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  • Dispositivo 26490
  • Fabricante 33665
  • Evento 35826
  • Implante 7175
Gebauer"s Topical anesthetic skin refrigerant
  • Modelo / Serial
    Lot numbers 6257 expires 08-08; 6258  expires 09-08 and 6259 expires 10/08; 6260 expires 11-08 and 6261 expires 12/08
  • Clasificación del producto
    Physical Medicine Devices
  • Clase de dispositivo
    Unclassified
  • ¿Implante?
    No
  • Distribución
    Nationwide
  • Descripción del producto
    Gebauer''s Pain Ease Medium Stream -Topical Anesthetic Skin Refrigerant is a vapocoolant (skin refrigerant) packed in an aerosol container. Rx only. 103.5ml (3.5 fl. oz.) can-(Product Number-0386-0008-03)
  • Manufacturer
    Gebauer Company
  • 1 Event
    • Retiro De Equipo (Recall) de Gebauer"s Topical anesthetic skin refrigerant
Gebauer"s Topical anesthetic skin refrigerant
  • Modelo / Serial
    Lot number 9253 expires 11-08
  • Clasificación del producto
    Physical Medicine Devices
  • Clase de dispositivo
    Unclassified
  • ¿Implante?
    No
  • Distribución
    Nationwide
  • Descripción del producto
    Gebauer''s Pain Ease Sample Spray -Topical Anesthtic Skin Refrigerant is a vapocoolant (skin refrigerant) packed in an aerosol container, Rx only, 30 mL(1.0 fl. oz.) can.-(Product Number-0386-0008-01)
  • Manufacturer
    Gebauer Company
  • 1 Event
    • Retiro De Equipo (Recall) de Gebauer"s Topical anesthetic skin refrigerant
Boston Scientiific PCNL
  • Modelo / Serial
    Batch/Lot Numbers: 8529320, 8568190, 9371965
  • Clasificación del producto
    Gastroenterology-Urology Devices
  • Clase de dispositivo
    Unclassified
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution; USA including states of OH, MS, NM, MD, and TX and Foreign country of Trinidad
  • Descripción del producto
    Boston Scientific PCNL (Percutaneous Tract) Kit with Nephromax Balloon; || Part Number: M0064501110
  • Manufacturer
    Boston Scientific Corporation
  • 1 Event
    • Retiro De Equipo (Recall) de Boston Scientiific PCNL
Harmonic Scalpel
  • Modelo / Serial
  • Clasificación del producto
    General and Plastic Surgery Devices
  • Clase de dispositivo
    Unclassified
  • ¿Implante?
    No
  • Distribución
    AL, AZ, CA, CO, CT, FL, GA, IA, ID, IL, IN, KS, KY, MA, MI, MN, MO, MS, MT, NC, ND, NE, NJ, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, WA, WI, and WV OUS: CANADA
  • Descripción del producto
    Harmonic Scalpel || Model #'s: || ETHACE14S || ETHACE23P || ETHACE36P || ETHCS14C || ETHFCS9 || ETHHDH05 || ETHLCS-C5 and || ETHLCSC5HA || Intended for use in soft tissue incisions when bleeding control and minimal thermal injury are desired.
  • Manufacturer
    Sterilmed Inc
  • 1 Event
    • Retiro De Equipo (Recall) de Harmonic Scalpel
PICIS
  • Modelo / Serial
    Software version 7.2.2
  • Clasificación del producto
    General Hospital and Personal Use Devices
  • Clase de dispositivo
    Unclassified
  • ¿Implante?
    No
  • Distribución
    Worldwide distribution: USA, Australia, Austria, Belgium, Denmark, Finland, France, Germany, Italy, Malaysia, Netherlands, Norway, Portugal, Singapore, Spain, Sweden, and United Kingdom
  • Descripción del producto
    PICIS, CareSuite Family- OR Manager (4235), Preop Manager (4250), Anesthesia Manager (4220), PACU Manager (4245) & Critical Care Manager (1110), patient information systems.
  • Manufacturer
    Picis Inc.
  • 1 Event
    • Retiro De Equipo (Recall) de PICIS
CareSuite" Critical Care Manager, PACU Manager and Anesthesia Manager
  • Modelo / Serial
    S/W version 7.1 release date - February 2004
  • Clasificación del producto
    General Hospital and Personal Use Devices
  • Clase de dispositivo
    Unclassified
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution-USA (nationwide) and the countries of Australia, Austria, Brussels, Belgium, Denmark, Finland, France, Germany, Malaysia, Netherlands, Norway, Portugal, Singapore, Spain, Sweden, and UK.
  • Descripción del producto
    CareSuite" - Critical Care Manager, PACU Manager and Anesthesia Manager Software, transmission & storage, patient data. || This product is a non-alarming software patient information system that compiles an electronic medical record utilizing commonly available hardware. A patient record is populated with information from various sources, such as health care professionals, medical devices connected to the system, and data that arrives via hospital and laboratory information systems. The application stores this information in a database and displays it to healthcare providers in different formats for informational purposes. The product is intended for use by healthcare professionals.
  • Manufacturer
    Picis Inc.
  • 1 Event
    • Retiro De Equipo (Recall) de CareSuite" Critical Care Manager, PACU Manager and Anesthesia Manager
SoftLab version 4.01 ASCII Lab/Mic Addon
  • Modelo / Serial
    SoftLab version 4.01 ASCII, ASCII Base 3.1.3.0-3.1.3.32, 3.1.4-3.1.4.27, 3.1.6-3.1.6.4, 4.0.0.0-4.0.0.9; LAB/MIC Add-on 4.0.1, 4.0.1.0-4.0.1.13, 4.0.2.0 in 2006.
  • Clasificación del producto
    General Hospital and Personal Use Devices
  • Clase de dispositivo
    Unclassified
  • ¿Implante?
    No
  • Distribución
    Nationwide Distribution: USA in the states of AL, AR, CA, CT, FL, GA, IA, IL, IN, KS, KY, LA, MD, ME, MI, MO, MS, NC, ND, NH, NJ, NY, OH, OK, PA, SD, TN, TX, VA, WA, WI, and WV.
  • Descripción del producto
    SoftLab version 4.01 ASCII, ASCII Base 3.1.3.0-3.1.3.32, 3.1.4-3.1.4.27, 3.1.6-3.1.6.4, 4.0.0.0-4.0.0.9; LAB/MIC Add-on 4.0.1, 4.0.1.0-4.0.1.13, 4.0.2.0 in 2006. || SCC Soft Computer, 5400 Tech Data Drive, Clearwater, FL 33760.
  • Manufacturer
    SCC Soft Computer
  • 1 Event
    • Retiro De Equipo (Recall) de SoftLab version 4.01 ASCII Lab/Mic Addon
Fresenius AS 104 Blood Cell Separator 2/03.11 (OPUSA)
  • Modelo / Serial
    The manual contains the operating instructions for AS 104 Blood Cell Separator and has a Software Version 4.71.   The AS104 Blood Cell Separator Device has a Catalog Number 9007031.
  • Clasificación del producto
    Gastroenterology-Urology Devices
  • Clase de dispositivo
    Unclassified
  • ¿Implante?
    No
  • Distribución
    Nationwided Distribution -- AK, AL, AR, AZ, CA, CO, CT, FL, GA, IA, IL, IN, KY, LA, MA, MI, MN, NC, NH, NJ, NM, NY, OH, PA, SD, TN, TX, VT, and WI.
  • Descripción del producto
    The Operating Manual contains the Operating Instructions for AS 104 Blood Cell Separator and has a Software Version 4.71. The AS 104 Blood Cell Separator Device has a Catalog Number 9007031. || Used for depletion or exchange of red blood cells during therapeutic apheresis procedures on the Fresenius AS 104 Blood Cell Separator Device. This set is used with a single stage separation chamber.
  • Manufacturer
    Fresenius Kabi, LLC
  • 1 Event
    • Retiro De Equipo (Recall) de Fresenius AS 104 Blood Cell Separator 2/03.11 (OPUSA)
Device Recall Integra CUSA Selector NXT Ultrasonic Surgical Aspirator
  • Modelo / Serial
    Serial Numbers: NBF1001601IE NBA1000501IE NBA1100901IE  NBA1101001IE NBA1102701IE  NBA1102801IE NBC1001501IE NBC1002001IE NBC1002301IE NBC1002901IE NBD1000101IE NBE1001301IE NBF1000701IE NBF1001101IE  NBG1001001IE NBG1001201IE NBJ1002401IE NBL0901901IE NBL0902101IE NBL0902501IE NCE1001901IE NCF1002201IE NCG1000201IE NCG1001401IE NCG1001501IE NXT1001 NXT1002 NXT1003 NXT1004 NXT1005 NXT1006 NXT1007 NXT1008 NXT1009 NXT1010 NXT1011 NXT1012 NXT1013 NXT1014 NXT1015 NXT1016 NXT1017 NXT1018 NXT1019 NXT1020P NXT1021 NXT1022 NXT1023 NXT1024 NXT1025 NXT1026 NXT1027 NXT1028 NXT1029 NXT1030 NXT1031 NXT1032 NXT1033 NXT1034 NXT1035 NXT1036 NXT1037 NXT1038 NXT1039 NXT1040 NXT1041 NXT1042 NXT1043 NXT1044 NXT1045 NXT1046 NXT1047 NXT1048 NXT1049 NXT1050 NXT1051 NXT1052 NXT1053 NXT1054 NXT1055 NXT1056 NXT1057 NXT1058 NXT1059 NXT1060 NXT1061 NXT1062 NXT1063 NXT1064 NXT1065 NXT1066 NXT1067 NXT1068 NXT1069 NXT1070 NXT1071 NXT1072 NXT1073 (Asia) NXT1074 NXT1075 NXT1076 NXT1077 NXT1078 NXT1079 NXT1080
  • Clasificación del producto
    General and Plastic Surgery Devices
  • Clase de dispositivo
    Unclassified
  • ¿Implante?
    No
  • Distribución
    Worldwide -- USA (nationwide) and countries of France, Germany, Hungary, Ireland, Italy, Netherlands, Spain, Sweden and Taiwan
  • Descripción del producto
    Integra CUSA NXT Ultrasonic Tissue Ablation System Service Module || The CUSA NXT Ultrasonic Surgical Aspirator System is indicated for use in surgical procedures where fragmentation. emulsification and aspiration of soft and hard (e.g. bone) tissue is desirable. including Neurosurgery. Gastrointestinal and affiliated organ surgery. Urological surgery. Plastic and Reconstructive surgery. General surgery, Orthopedic surgery. Gynecological surgery, Thoracic surgery. laparoscopic surgery and Thoracoscopic surgery.
  • Manufacturer
    Integra Limited
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall Integra CUSA Selector NXT Ultrasonic Surgical Aspirator
Device Recall Spectra Optia Apheresis System
  • Modelo / Serial
    Serial Numbers: 1P00100 thru 1P00719
  • Clasificación del producto
    Gastroenterology-Urology Devices
  • Clase de dispositivo
    Unclassified
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution--USA (nationwide) and countries of Australia, Belgium, Canada, China, Hong Kong, Japan, Malaysia, Mexico, Pakistan, Saudi Arabia, Singapore, South Korea, Taiwan, Thailand, and Vietnam.
  • Descripción del producto
    Spectra Optia Apheresis System, REF: 61000, CaridianBCT, Lakewood, CO 80215. || The Spectra Optia Apheresis System, a blood component separator, is intended for use in therapeutic apheresis applications. The system may be used to perform Therapeutic Plasma Exchange, Mononuclear Cell Collection, and Red Blood Cell Exchange.
  • Manufacturer
    Caridian BCT, Incorporated
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall Spectra Optia Apheresis System
Device Recall ONQ Silver Dressing
  • Modelo / Serial
    Lot Numbers: H0705J (I-Flow Lots 17055 and 17054) and H0706J (I-Flow Lot 17054). Expiration date: 11/1/2008.
  • Clasificación del producto
    General and Plastic Surgery Devices
  • Clase de dispositivo
    Unclassified
  • ¿Implante?
    No
  • Distribución
    Nationwide distribution -- DE, FL, KY, OR, IN, TX, NV, MT, CA and NY.
  • Descripción del producto
    ON-Q Silver Dressing is a Antimicrobial wound dressing containing silver. It is individually wrapped in a foil pouch. Each pouch contains 1 single use 4" x 4.5" pad. There are 5 pouches per box. Ref: SD4X4.5; Part Number: IF-151023 and IF-151026. || The product is labeled in parts: "***5 DRESSINGS***4 X 4.5 INCHES***REF SD4X4.5***PART NO. 5001826***ON-Q SilverDressing is a silver containing adhesive transparent polyurethane film for fixation and securement of devices to the skin as a primary contact sound dressing***MANUFACTURED BY ACRYMED***DISTRIBUTED BY I-FLOW***AcryMed, Inc Beaverton, OR 97008***". || Intended for use in securing devices such as catheters to the skin. Also intended for use as a primary or secondary cover wound dressing on surgical incision sites.
  • Manufacturer
    Acrymed Incorporated
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall ONQ Silver Dressing
Device Recall Microcyn Solution
  • Modelo / Serial
    Part number: 84798; - 500 mL Lot numbers: OIS00011-01, exp 1/12; OIS00011-02, exp 1/12; 10l0119, exp 8/12; 10J0145, exp 8/12; 10K0158, exp 8/12; 10K0159, exp 8/12; 10K0160, exp 8/12; 11C0130, exp 2/13.  Part number 84781: - 990 mL lot numbers: OIS00012-01, exp 1/12; OIS00012-02, ecp 1/12; 10E0086-01, exp 5/12; 10l0120, exp 8/12; 10J0145, exp 8/12; 11A0042, exp 1/13; 11B0056, exp 2/13; 11B0081-01, exp 2/13; 11B0082-02, exp 2/13; 11E0192, exp 6/13; 11F0197, exp 6/13.
  • Clasificación del producto
    General and Plastic Surgery Devices
  • Clase de dispositivo
    Unclassified
  • ¿Implante?
    No
  • Distribución
    Nationwide Distribution.
  • Descripción del producto
    Microcyn Solution with Preservatives (Rx), 16.9 fl oz (500 mL) and 33.5 fl oz. (990 mL) || Ingredients: Electrolyzed Water (99.97%) Sodium Chloride (NaCl) (230 mg/L) and preservatives: Sodium Hypochlorite (Na0Cl) (40 mg/L), Hypochlorous acid (H0CL) (30 mg/L) || -Non Foaming || -Does not contain antibiotics || - Does not facilitate resistance || - No known drug/treatment interactions or contraindications || -laboratory proven in solution inactivation of bacteria, viruses, fungi and spores. || Performance testing: Microcyn Solution with Preservatives has been evaluated by the USP <51> antimicrobial Effectiveness Test and in Time-Kill studies. It has demonstrated effectiveness by reducing the microorganisms listed below and passed the USP antimicrobial Effectiveness test for a category 1 product. || Oculus Innovative Sciences' || Petaluma, CA 94954. || Intended to be used by health care professionals in the management in wounds.
  • Manufacturer
    Oculus Innovative Sciences Inc
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall Microcyn Solution
Device Recall Puracyn OTC Wound & Skin Care Solution
  • Modelo / Serial
    Part number: 6000;80003 (8 oz trigger spray): Lot numbers: 10E0084-01, exp 11/11; 10F0099, exp 12/11; 10F0105, exp 12/11; 041311-01, exp 5/12.  Part number: 6002; 80001, (8 oz finger pump); lot number s: 041311-01, exp 5/12;  081710-01, exp.9/11;  120810-01, exp 2/2012; 073010-02, exp 11/11.  Part number: 6004; 80005. 16 oz with insert:  061511-02. exp 12/12.
  • Clasificación del producto
    General and Plastic Surgery Devices
  • Clase de dispositivo
    Unclassified
  • ¿Implante?
    No
  • Distribución
    Nationwide Distribution.
  • Descripción del producto
    Puracyn OTC; || Wound & Skin Care Solution with Preservatives; Sold in 8 fl oz (trigger spray and finder pump) and 16 fl oz pump with insert. || Kills 99.99% of Staph, MRSA, Strep and other Infectious Germs in 30 seconds in solution. || Does not contain Antibiotics, Steroids or Alcohol. || -Cleans infected wounds in one step || - Safe to use around eyes, nose, m mouth and open wounds || - Accelerated healing of minor wounds by keeping the wound clean || -Non-toxic and non-irritating. || Manufactured by Oculus Innovative Sciences for Innovaycen, Inc. || 3546 N. Riverside Ave. Rialto, CA 92377 || Made in USA. || Intended for OTC use for the management of skin abrasions, lacerations, minor irritations, cuts, and intact skin.
  • Manufacturer
    Oculus Innovative Sciences Inc
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall Puracyn OTC Wound & Skin Care Solution
Device Recall Microcyn Dermatology Spray
  • Modelo / Serial
    Part number: 84866 - 8 oz spray bottle lot numbers: 11G0108, exp 1/12; 10H0113-01, exp 2/12; 10H0118-01, exp 8/12; 10l0122-03, exp 3/12; 10l0125-01, exp 3/12; 10J0137-03, exp 4/12; 10K0164, exp 5/12; 11B0068-01, exp 8/12.
  • Clasificación del producto
    General and Plastic Surgery Devices
  • Clase de dispositivo
    Unclassified
  • ¿Implante?
    No
  • Distribución
    Nationwide Distribution.
  • Descripción del producto
    Microcyn Dermatology Spray with germ killing Preservatives (Rx); 8 fl oz. || 99.999% Reduction In-solution in 30 seconds. || MRSA - Staphylococcus aureus || VFR - Enterococcus faecalis || Acinetobacter baumannii || Pseudomonas aeruginosa. || Microcyn Dermatology Spray has been evaluated by the USP <51> Antimicrobial Effectiveness Test and in Time Kill studies. It has demonstrated effectiveness by reducing the microorganisms listed below and passed the USP antimicrobial Effectiveness test for a Category 1 product. || Safe to use around eyes, nose and mouth. || Oculus Innovative Sciences . || Petaluma, CA 94954. || Intended for use by health care professionals in management via debridement of wounds
  • Manufacturer
    Oculus Innovative Sciences Inc
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall Microcyn Dermatology Spray
Device Recall Microcyn Dermatology HydroGel Spray
  • Modelo / Serial
    Part number: 84811 - 1.76 oz. Lot numbers: 10C0030-03, exp 3/12; 10C0034-03, exp 3/12; 10D0051-01, exp 4/12; 10D0059-02, exp 4/12; 10E0076-01, exp 5/12; 10H0112-03, exp 8/12; 10H0116-03, exp 8/12; 10J0143-02, exp 10/12; 11B0051-01, exp 2/13.  Part number 84828, 4 oz. lot 10C0032, exp 3/12.
  • Clasificación del producto
    General and Plastic Surgery Devices
  • Clase de dispositivo
    Unclassified
  • ¿Implante?
    No
  • Distribución
    Nationwide Distribution.
  • Descripción del producto
    Microcyn Dermatology HydroGel, Spray , 4 oz and 1.76 oz. || Provided Pain Relief, Relieve Itch, Reduces symptoms of inflammation due to irritation, Provide a protective shield against contamination. || Antibiotic-free, steroid-free and biodegradable.. || Oculus Innovative Sciences . || Petaluma, CA 94954. || Intended for use by health care professionals in management of wounds including itch and pain relief associated with dermal irritation, sore, injuries and ulcers or dermal tissue. Microcyn Skin and Wound hydrogel is intended for use on first and second degree burns, excluding wounds such as leg ulcers, pressure ulcers, diabetic ulcers, and for the management of mechanically or surgically debrided wounds.
  • Manufacturer
    Oculus Innovative Sciences Inc
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall Microcyn Dermatology HydroGel Spray
Device Recall Softlab
  • Modelo / Serial
    Softlab with DORA versions: 2.0.0.4 with Hot Fix 1.2808, 1.2809, 1.2956, or 1.3476; 2.0.0.5; 2.0.0.6; 2.0.0.7 with Hot Fix 1.6595; and 2.1.0.3.
  • Clasificación del producto
    General Hospital and Personal Use Devices
  • Clase de dispositivo
    Unclassified
  • ¿Implante?
    No
  • Distribución
    Sold throughout US and Canada.
  • Descripción del producto
    SCC Soft Computer, Softlab Laboratory information System with DORA versions: 2.0.0.4 with Hot Fix 1.2808, 1.2809, 1.2956, or 1.3476; 2.0.0.5; 2.0.0.6; 2.0.0.7 with Hot Fix 1.6595; and 2.1.0.3.
  • Manufacturer
    SCC Soft Computer
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall Softlab
Device Recall SoftLab GUI versions 4.0.2.84.0.2.10; 4.0.3.124.0.3.13; and 4.0.4.14.0.4.4.
  • Modelo / Serial
    SoftLab GUI versions 4.0.2.8-4.0.2.10; 4.0.3.12-4.0.3.13; and 4.0.4.1-4.0.4.4.
  • Clasificación del producto
    General Hospital and Personal Use Devices
  • Clase de dispositivo
    Unclassified
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution-- USA ( nationwide) and Canada.
  • Descripción del producto
    SoftLab GUI versions 4.0.2.8-4.0.2.10; 4.0.3.12-4.0.3.13; and 4.0.4.1-4.0.4.4. || SoftLab is a laboratory information system to be used in a medical research or clinical laboratory by knowledgeable, trained, and experienced personnel. SoftLab enables the user to handle data-processing and laboratory activities, for the purpose of storing, managing, querying, and report laboratory data.
  • Manufacturer
    SCC Soft Computer
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall SoftLab GUI versions 4.0.2.84.0.2.10; 4.0.3.124.0.3.13; and 4.0.4.14.0.4.4.
Device Recall SoftPath GUI Versions: 4.3.0.10, 4.3.0.11, and 4.3.0.12.
  • Modelo / Serial
    SoftPath GUI Versions: 4.3.0.10, 4.3.0.11, and 4.3.0.12.
  • Clasificación del producto
    General Hospital and Personal Use Devices
  • Clase de dispositivo
    Unclassified
  • ¿Implante?
    No
  • Distribución
    Class II Recall - Worldwide Distribution -- USA (nationwide) and the country of Canada.
  • Descripción del producto
    SoftPath GUI Versions: 4.3.0.10, 4.3.0.11, and 4.3.0.12. || SoftPath is a laboratory information system to be used in a clinical laboratory by knowledgeable, trained, and experienced personnel. SoftPath enables the user to document steps in the receiving and processing of surgical, gynecological, medical cytological, and autopsy case specimens within the Pathology labs, for the purpose of generating Pathology reports for requesting physicians and label creation for identification of specimen/case material.
  • Manufacturer
    SCC Soft Computer
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall SoftPath GUI Versions: 4.3.0.10, 4.3.0.11, and 4.3.0.12.
Device Recall TX1 Tissue Removal System Console
  • Modelo / Serial
    Product Codes: LFL, GEI,  Serial #: 55400001, 55400002, 55400003. Part Order No: 554-0034-000 510(K) Mp.: K101561
  • Clasificación del producto
    General and Plastic Surgery Devices
  • Clase de dispositivo
    Unclassified
  • ¿Implante?
    No
  • Distribución
    Nationwide distribution: MN only.
  • Descripción del producto
    TX1 Tissue Removal System Console. Model: TX1 || TX1 Tissue Removal System is an ultrasonic aspirator that emulsifies and removes soft tissue. The TX1 Console provides control over each mode of operation, as well as the user interface via LCD touchscreen and audible tones for confirmation of user selections. || Indiciated for use in surgical procedures where fragmentation, emulsification, and aspiration of soft tissue are desirable, including General Surgery, Orthopedic Surgery, Laparoscopic Surgery and Plastic and Reconstructive Surgery.
  • Manufacturer
    American Optisurgical Inc
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall TX1 Tissue Removal System Console
Device Recall ENSEAL Laparoscopic 5 mm Diameter Tissue Sealer G2 35 cm Length Curved Jaw
  • Modelo / Serial
    Product Code 00NSLG2C35, Lot #, H44V7M, Exp Date, Oct-2013, Lot # H44V7N, Exp Date, Oct-2013, Lot # H44V7P, Exp Date, Oct-2013, Lot # H44X9L, Exp Date, Nov-2013, Lot # H44X9M, Exp Date, Nov-2013, Lot # H44X9R, Exp Date, Nov-2013, Lot # H44Z3R, Exp Date, Nov-2013, Lot # H44Z4C, Exp Date, Nov-2013, Lot # H44Z54, Exp Date, Nov-2013, Lot # J4A085, Exp Date, Dec-2013 & Lot # J4A134, Exp Date, Dec-2013; Product Code 00NSLG2C45, Lot #, H44W25, Exp Date, Oct-2013, Lot # H44W26, Exp Date, Oct-2013, Lot # H44W27, Exp Date, Oct-2013 & Lot # J4A19D, Exp Date, Dec-2013
  • Clasificación del producto
    General and Plastic Surgery Devices
  • Clase de dispositivo
    Unclassified
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - USA including AZ, CA, CT, FL, IL, IN, KS, KY, MA, MI, MO, NC, NY, OH, PA, TN & TX and the countries of Arab Emirates, Austria, Belgium, France, Germany, Great Britain, Italy, Jordan, Kingdom of Saudi Arabia, Lebanon, Portugal, Slovenia, Sweden and Turkey.
  • Descripción del producto
    ENSEAL¿ Laparoscopic 5 mm Diameter Tissue Sealer G2 35 cm Length Curved Jaw, Model # NSLG2C35 and ENSEAL¿ Laparoscopic 5 mm Diameter Tissue Sealer G2 45 cm Length Curved Jaw, Model # NSLG2C45. Ethicon Endo-Surgery, LLC Guaynabo, Puerto Rico 00969 || The ENSEAL¿ G2 Tissue Sealers are indicated for bipolar coagulation and mechanical transection of tissue during laparoscopic and open procedures. The devices are bipolar electrosurgical instruments for use with an electrosurgical generator. They are intended for use during open or laparoscopic, general and gynecological surgery to cut and seal vessels, and to cut, grasp and dissect tissue during surgery. Indications for use include open and laparoscopic, general and gynecological surgical procedures (including urologic, thoracic, plastic and reconstructive, bowel resections, hysterectomies, cholecystectomies, gall bladder procedures, Nissen fundoplication, adhesiolysis, oophorectomies, etc.), or any procedure where vessel ligation (cutting and sealing), tissue grasping and dissection is performed. The devices can be used on vessels up to (and including) 7 mm and bundles as large as will fit in the jaws of the instruments.
  • Manufacturer
    Ethicon Endo-Surgery Inc
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall ENSEAL Laparoscopic 5 mm Diameter Tissue Sealer G2 35 cm Length Curved Jaw
Device Recall ENSEAL 5 mm Diameter Tissue Sealer G2 14 cm Length Straight Jaw
  • Modelo / Serial
    Product Code 00NSLG2S14, Lot #, H44Z5R, Exp Date, Nov-2013; Product Code 00NSLG2S25, Lot #, H44Z57, Exp Date, Nov-2013 & Lot # J4A28X, Exp Date, Dec-2013
  • Clasificación del producto
    General and Plastic Surgery Devices
  • Clase de dispositivo
    Unclassified
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - USA including AZ, CA, CT, FL, IL, IN, KS, KY, MA, MI, MO, NC, NY, OH, PA, TN & TX and the countries of Arab Emirates, Austria, Belgium, France, Germany, Great Britain, Italy, Jordan, Kingdom of Saudi Arabia, Lebanon, Portugal, Slovenia, Sweden and Turkey.
  • Descripción del producto
    ENSEAL¿ 5 mm Diameter Tissue Sealer G2 14 cm Length Straight Jaw, Model # NSLG2S14 and ENSEAL¿ 5 mm Diameter Tissue Sealer G2 25 cm Length Straight Jaw, Model # NSLG2S25. Ethicon Endo-Surgery, LLC Guaynabo, Puerto Rico 00969 || The ENSEAL¿ G2 Tissue Sealers are indicated for bipolar coagulation and mechanical transection of tissue during laparoscopic and open procedures. The devices are bipolar electrosurgical instruments for use with an electrosurgical generator. They are intended for use during open or laparoscopic, general and gynecological surgery to cut and seal vessels, and to cut, grasp and dissect tissue during surgery. Indications for use include open and laparoscopic, general and gynecological surgical procedures (including urologic, thoracic, plastic and reconstructive, bowel resections, hysterectomies, cholecystectomies, gall bladder procedures, Nissen fundoplication, adhesiolysis, oophorectomies, etc.), or any procedure where vessel ligation (cutting and sealing), tissue grasping and dissection is performed. The devices can be used on vessels up to (and including) 7 mm and bundles as large as will fit in the jaws of the instruments.
  • Manufacturer
    Ethicon Endo-Surgery Inc
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall ENSEAL 5 mm Diameter Tissue Sealer G2 14 cm Length Straight Jaw
Device Recall ENSEAL Laparoscopic 5 mm Diameter Tissue Sealer G2 35 cm Length Straight Jaw
  • Modelo / Serial
    Product Code 00NSLG2S35, Lot #, H44Y6N, Exp Date, Nov-2013, Lot # H44Y8A, Exp Date, Nov-2013, Lot # H44Y8K, Exp Date, Nov-2013, Lot # H44Z65, Exp Date, Nov-2013, Lot # H44Z6J, Exp Date, Nov-2013 & Lot # J4A164, Exp Date, Dec-2013.
  • Clasificación del producto
    General and Plastic Surgery Devices
  • Clase de dispositivo
    Unclassified
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - USA including AZ, CA, CT, FL, IL, IN, KS, KY, MA, MI, MO, NC, NY, OH, PA, TN & TX and the countries of Arab Emirates, Austria, Belgium, France, Germany, Great Britain, Italy, Jordan, Kingdom of Saudi Arabia, Lebanon, Portugal, Slovenia, Sweden and Turkey.
  • Descripción del producto
    ENSEAL¿ Laparoscopic 5 mm Diameter Tissue Sealer G2 35 cm Length Straight Jaw, Model # NSLG2S35. Ethicon Endo-Surgery, LLC Guaynabo, Puerto Rico 00969 || The ENSEAL¿ G2 Tissue Sealers are indicated for bipolar coagulation and mechanical transection of tissue during laparoscopic and open procedures. The devices are bipolar electrosurgical instruments for use with an electrosurgical generator. They are intended for use during open or laparoscopic, general and gynecological surgery to cut and seal vessels, and to cut, grasp and dissect tissue during surgery. Indications for use include open and laparoscopic, general and gynecological surgical procedures (including urologic, thoracic, plastic and reconstructive, bowel resections, hysterectomies, cholecystectomies, gall bladder procedures, Nissen fundoplication, adhesiolysis, oophorectomies, etc.), or any procedure where vessel ligation (cutting and sealing), tissue grasping and dissection is performed. The devices can be used on vessels up to (and including) 7 mm and bundles as large as will fit in the jaws of the instruments.
  • Manufacturer
    Ethicon Endo-Surgery Inc
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall ENSEAL Laparoscopic 5 mm Diameter Tissue Sealer G2 35 cm Length Straight Jaw
Device Recall HARMONIC Blue Hand Piece & HARMONIC Hand Piece
  • Modelo / Serial
    HARMONIC¿ HP054 Hand Pieces Lot Numbers produced to-date: H92Y3M, J9039C, J90817, J90E7C, J9000C, J90432, J9084W, J90E7Z, J90029, J90470, J9088L, J90F3G,J9006C, J9054E, J9093L, J90F7Z, J9011D, J9056K, J9095C, J90G32, J90151, J9057V,J90974, J90G9Y,J9018H, J9058L, J90A45, J90H37,J9020F, J90624, J90A72, J90H4U, 9023D, J90681, J90C7X, J90H7D,J9027C, J9069F, J90C84, J90H9Y,J90314, J90726, J90D4N, J90J2N,J9034N, J90762, J90E0R, J90J8E,J9038W, J9076A, and J90E29.   HARMONIC¿ HPBLUE Hand Pieces Lot Numbers produced to-date: J9001P, J9053N, J9091G, J90D84,J9005J, J9057E, J90A2C, J90E55,J9010E, J9065U, J90A64, J90F76,J9042G, J90696, J90C36, J90G4C,J9050E, J9086W, J90C7U, and J90H46.
  • Clasificación del producto
    General and Plastic Surgery Devices
  • Clase de dispositivo
    Unclassified
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution-USA including: AK,AL,AR,AZ,CA,CO,CT,DE,FL,GA,HI,IA,ID,IL,IN,KS,KY,LA,MA,MD,ME,MI,MN,MO,MS,MT,NCND,NE,NH,NJ,NM,NV,NY,OH,OK,OR,PA,RI,SC,SD,TN,TX,UT,VA,VT,WA,WI,WV, and WY. and the countries of: Argentina, Australia, Belgium, Brazil, Canada, Chile, China, Colombia, Cyprus, Ecuador, Egypt, Greece, Hong Kong, India, Indonesia, Israel, Japan, Jordan, Korea (South),Kuwait, Lebanon, Malaysia, Mexico, Netherlands, Antilles, Pakistan, Panama, Puerto Rico, Russia, Saudi Arabia, Singapore, Slovenia, South Africa, Taiwan, Thailand, Turkey, United Arab Emirates Uruguay, Venezuela & Yemen.
  • Descripción del producto
    HPBLUE: HARMONIC¿ Blue Hand Piece; HP054: HARMONIC¿ Hand Piece; Non-Sterile products are individually packed in a poly bag and then placed into an individual carton. Mfr. By: Ethicon Endo-Surgery, LLc, 475 Calle C, Guaynbo, PR 00969. || Indicated for soft tissue incisions when bleeding control and minimal thermal injury are desired. The instruments can be used as an adjunct to or substitute for electrosurgery, lasers, and steel scalpels.
  • Manufacturer
    Ethicon Endo-Surgery Inc
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall HARMONIC Blue Hand Piece & HARMONIC Hand Piece
Device Recall Terumo BCT
  • Modelo / Serial
    Lot numbers 1P00881 1P00545 1P00310 1P00888 1P00595 1P00652 1P00594 1P00230 1P00592 1P00804 1P00596 1P00878 1P00327 1P00166 1P00566 1P00135 1P00882 1P00681 1P00482 1P00604 1P00379 1P00422 1P00781 1P00235 1P00184 1P00441 1P00523 1P00520 1P00854 1P00795 1P00299 1P00671 1P00941 1P00461 1P00817 1P00787 1P00822 1P00672 1P00840 1P00866 1P00622 1P00389 1P00392 1P00391 1P00400 1P00394 1P00384 1P00430 1P00168 1P00933 1P00167 1P00462 1P00211 1P00162 1P00541 1P00703 1P00874 1P00591 1P00884 1P00782 1P00440 1P00646 1P00457 1P00542 1P00600 1P00147 1P00701 1P00298 1P00358 1P00393 1P00732 1P00228 1P00560 1P00177 1P00176 1P00242 1P00616 1P00387 1P00780 1P00142 1P00557 1P00172 1P00774 1P00791 1P00655 1P00511 1P00451 1P00472 1P00207 1P00669 1P00768 1P00290 1P00641 1P00534 1P00429 1P00598 1P00538 1P00515 1P00608 1P00916 1P00551 1P00353 1P00240 1P00790 1P00815 1P00268 1P00642 1P00621 1P00537 1P00361 1P00687 1P00522 1P00160 1P00512 1P00586 1P00402 1P00785 1P00731 1P00447 1P00239 1P00640 1P00453 1P00191 1P00851 1P00169 1P00606 1P00662 1P00277 1P00684 1P00311 1P00436 1P00885 1P00226 1P00302 1P00385 1P00345 1P00229 1P00803 1P00778 1P00222 1P00509 1P00666 1P00459 1P00267 1P00434 1P00141 1P00251 1P00143 1P00565 1P00382 1P00232 1P00491 1P00627 1P00553 1P00636 1P01183 1P00349 1P00981 1P00513 1P00617 1P00238 1P00639 1P00688 1P00285 1P00995 1P00810 1P01182 1P00212 1P00559 1P00982 1P00590 1P00848 1P01115 1P00900 1P01185 1P00811 1P00203 1P00605 1P00321 1P00868 1P00459 1P00267 1P00669 1P00560 1P00884 1P00141 1P00143.
  • Clasificación del producto
    Gastroenterology-Urology Devices
  • Clase de dispositivo
    Unclassified
  • ¿Implante?
    No
  • Distribución
    US Nationwide Distribution and the country of Canada.
  • Descripción del producto
    Terumo BCT Lakewood, CO 80215, Catalog No 61000 Spectra Optia Apheresis System, Country of Origin: US. || Product Usage: || For use in humans. Within the US marketplace, this device is approved for use in Therapeutic Plasma Exchange. Internationally, this device is approved for use in Mono Nucleo Cell engraftment.
  • Manufacturer
    CaridianBCT, Inc.
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall Terumo BCT
Device Recall Siemens syngo(R) Lab Data Manager
  • Modelo / Serial
    Version VA11B and all previously released versions.
  • Clasificación del producto
    General Hospital and Personal Use Devices
  • Clase de dispositivo
    Unclassified
  • ¿Implante?
    No
  • Distribución
    USA (nationwide) including the states of AZ, CA, MS, MO, NJ, NC, OH, OR, PA, and TX.
  • Descripción del producto
    Siemens syngo(R) Lab Data Manager. || The syngo(R) Lab Data Manager is classified as a data calculator and processing module for use with In-vitro diagnostic devices. It also provides work flow management as well as remote instrument control to multiple interfaced instruments
  • Manufacturer
    Siemens Healthcare Diagnostics, Inc.
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall Siemens syngo(R) Lab Data Manager
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Aviso

Los dispositivos médicos ayudan con el diagnóstico, la prevención y el tratamiento de muchas lesiones y enfermedades. A través de la International Medical Devices Database no estamos sugiriendo que compañías u otras entidades mencionadas en la base de datos hayan sido parte de una conducta ilegal o hayan actuado de manera impropia. Un mismo dispositivo médico puede tener distintos nombres en diferentes países. Esta base de datos no busca proporcionar asesoría médica. Los pacientes deben consultar con sus médicos para determinar si la data contiene información relevante y si la misma tiene implicaciones médicas para ellos.

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