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  • Dispositivo 26490
  • Fabricante 33665
  • Evento 35826
  • Implante 7175
Device Recall GAUZE SPONGE 4"X4" 16 PLY SOFT
  • Modelo / Serial
    Code:9004165 Lots: 141015896 exp. 12/31/99 141216338 exp. 12/31/99 150418409 exp. 12/31/99
  • Clasificación del producto
    General and Plastic Surgery Devices
  • Clase de dispositivo
    Unclassified
  • ¿Implante?
    No
  • Distribución
    Distributed Only in Puerto Rico.
  • Descripción del producto
    GAUZE SPONGE 4"X4" 16 PLY SOFT 1280/CS || Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc. || .
  • Manufacturer
    Customed, Inc
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall GAUZE SPONGE 4"X4" 16 PLY SOFT
Device Recall GAUZE SPONGE 4"X4" 16 PLY XRD
  • Modelo / Serial
    Code:9005416 Lots: 141015903 exp. 12/31/99 141216348 exp. 12/31/99 150317999 exp. 12/31/99 150418415 exp. 12/31/99
  • Clasificación del producto
    General and Plastic Surgery Devices
  • Clase de dispositivo
    Unclassified
  • ¿Implante?
    No
  • Distribución
    Distributed Only in Puerto Rico.
  • Descripción del producto
    GAUZE SPONGE 4"X4" 16 PLY XRD 1280/CS (STERILE) || Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc. || .
  • Manufacturer
    Customed, Inc
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall GAUZE SPONGE 4"X4" 16 PLY XRD
Device Recall Tegaderm
  • Modelo / Serial
    Kit #73775, Lot 213403
  • Clasificación del producto
    General and Plastic Surgery Devices
  • Clase de dispositivo
    Unclassified
  • ¿Implante?
    No
  • Distribución
    Nationwide distribution to MO, NE and TX .
  • Descripción del producto
    PICC/CVC Secure Dressing Change kit, Ref: 73775, Lot 213403, Sterile Single Use, Medical Action Industries, Inc., Arden, NC. || This kit is used by clinicians to change dressings
  • Manufacturer
    Medical Action Industries Inc
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall Tegaderm
Device Recall Alaris PC Unit, Model 8000, Infusion Pump power supply board part Part No. TC10005...
  • Modelo / Serial
    Serial No. 4044845 9950535 4064411 12475162 4045659 9899143 3606478 4021398 4093501 4043745 4063430 4094994 9907675 9945292 9922622 4043375 12409069 4020663 12498854 4044531 4058193 12351849 4064030 9925068 12426138 4063830 4063911 9945269
  • Clasificación del producto
    General and Plastic Surgery Devices
  • Clase de dispositivo
    Unclassified
  • ¿Implante?
    No
  • Distribución
    Nationwide in US: AR, AZ, CA, FL, GA, IN, KY, MD, MI, MN, MO, NJ, NM, NY, OH, OR, PA, SC, TN, TX, VA, WI.
  • Descripción del producto
    Alaris PC Unit, Infusion Pump Model 8000, Part No. TC10005092
  • Manufacturer
    CareFusion 303, Inc.
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall Alaris PC Unit, Model 8000, Infusion Pump power supply board part Part No. TC10005092.
Device Recall Ultraxx
  • Modelo / Serial
    Catalog # UNBS-1 0-15-CS GPN# G30357 Lot# 5082013 Exp: 06/01/2017
  • Clasificación del producto
    Gastroenterology-Urology Devices
  • Clase de dispositivo
    Unclassified
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - US including GA, ID, LA, OR, SC, TX and Internationally to CHINA.
  • Descripción del producto
    UltraxxTM Nephrostomy Balloon Set || The Ultraxx" Nephrostomy Balloon Set consists of a radiopaque balloon catheter, radiopaque sheath, and inflation device. The Ultraxx" Nephrostomy Balloon Set is used to dilate the musculofascia, renal capsule, and parenchyma to establish and maintain a percutaneous tract.
  • Manufacturer
    Cook Inc.
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall Ultraxx
Device Recall Ascend AQ
  • Modelo / Serial
    Catalog # AUBS-6-4 GPN# G32840 Lot# 5083854 Exp: 06/01/2017
  • Clasificación del producto
    Gastroenterology-Urology Devices
  • Clase de dispositivo
    Unclassified
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - US including GA, ID, LA, OR, SC, TX and Internationally to CHINA.
  • Descripción del producto
    Ascend¿ AQ¿ Ureteral Dilation Balloon Catheter Set || The Ascend¿ AQ¿ Ureteral Dilation Balloon Catheter Set consists of a radiopaque balloon catheter and inflation device. The Ascend¿ AQ¿ Ureteral Dilation Balloon Catheter Set is used for transluminal dilation of ureteral strictures or ureteral dilation prior to ureteroscopy and stone manipulation.
  • Manufacturer
    Cook Inc.
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall Ascend AQ
Device Recall Syva Emit Methotrexate Assay
  • Modelo / Serial
    Lot # F1, F2, G1, G2, H1, and H2
  • Clasificación del producto
    Clinical Chemistry and Clinical Toxicology Devices
  • Clase de dispositivo
    Unclassified
  • ¿Implante?
    No
  • Distribución
    Units were shipped to MI, FL, NJ, NY, DC, CA, GA, MI, MT, VA, NC, TX, PA, Australia, Belgium, Czech Republic, Finland, Japan, Republic of Korea, Italy, Saudi Arabia, Slovakia, Slovenia, Spain and Switzerland.
  • Descripción del producto
    Syva Emit Methotrexate Assay, is a homogeneous enzyme immunoassay intended for use in the quantitative analysis of methotrexate in human serum or plasma.
  • Manufacturer
    Siemens Healthcare Diagnostics, Inc.
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall Syva Emit Methotrexate Assay
Device Recall The Spetzler Claw"
  • Modelo / Serial
    5450-800-311  Lot Number 0545410 5450-800-313  Lot Number 0555170
  • Clasificación del producto
    General and Plastic Surgery Devices
  • Clase de dispositivo
    Unclassified
  • ¿Implante?
    No
  • Distribución
    Distributed in the states of AZ, CA, CO, CT, IL, IN, MD, MI, MN, NY, PA, SC, TN, WA, WI, and VA, and in the NETHERLANDS.
  • Descripción del producto
    Spetzler Claw Tip, Universal - 5450-800-311 || Spetzler Open Angle Micro Claw Tip, Universal - 5450-800-313 || The Spetzler Claw" Tips are bone cutting tips which are a part of Strykers Neuro Spine Ear, Nose and Throat (ENT) Sonopet Portfolio. They are removable attachments intended to be used with the Sonopet Ultrasonic Handpiece.
  • Manufacturer
    Stryker Instruments Div. of Stryker Corporation
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall The Spetzler Claw"
Device Recall AllergiEnd ST9 Multiple Skin Test Applicator (Item 1000) and AllergiEnd ST9 Multip...
  • Modelo / Serial
    All lots
  • Clasificación del producto
    General Hospital and Personal Use Devices
  • Clase de dispositivo
    Unclassified
  • ¿Implante?
    No
  • Distribución
    Nationwide Distribution to AZ, CA, CO, CT, FL, GA, LA, MD, MI, NJ, NY, PA, TX, VA, and WA.
  • Descripción del producto
    AllergiEnd ST-9 Multiple Skin Test Applicator (Item 1000) and AllergiEnd ST-9 Multiple Well Test Tray (Item (1001). Contents: 8 applicators to perform up to 72 skin tests. || Perform a multi-site skin test to identify reactions to certain allergens using a non-invasive applicator that contains 70 different allergens and histamine
  • Manufacturer
    Medscience Inc
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall AllergiEnd ST9 Multiple Skin Test Applicator (Item 1000) and AllergiEnd ST9 Multiple Well Test Tra
Device Recall American Surgical
  • Modelo / Serial
    Lot numbers:  2015/12 BE
  • Clasificación del producto
    General and Plastic Surgery Devices
  • Clase de dispositivo
    Unclassified
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - US Nationwide and the countries of Australia, Belgium, Canada, France, Germany, Greece, Hong Kong, Hong Kong, Israel, Italy, Italy, Japan, Netherlands, New Zealand, Portugal, Saudi Arabia, South Africa, Spain, Sweden, Switzerland, and United Kingdom.
  • Descripción del producto
    American Surgical Tonsil Sponges 1" Large || Ref Number: 50-01 || Product Usage: || Neurosurgical and Nonneurosurgical Sponges
  • Manufacturer
    American Surgical Company
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall American Surgical
Device Recall Best Theratronics cabinet xray systems
  • Modelo / Serial
    All Raycell units with serial #'s 5000 and higher.
  • Clasificación del producto
    Radiology Devices
  • Clase de dispositivo
    Unclassified
  • ¿Implante?
    No
  • Distribución
    Nationwide
  • Descripción del producto
    Best Theratronics cabinet x-ray systems intended for use in the irradiation of blood and blood products (packaged in transfusion bags) to inactivate T-lymphocytes for the prevention of Graft Versus Host Disease.
  • Manufacturer
    BEST THERATRONICS LTD.
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall Best Theratronics cabinet xray systems
Device Recall Neptune Plus (Hemostatic Pad)
  • Modelo / Serial
    Lot R970249
  • Clasificación del producto
    General and Plastic Surgery Devices
  • Clase de dispositivo
    Unclassified
  • ¿Implante?
    No
  • Distribución
    Nationwide Distribution to AL, CA, FL, GA, IL, IN, KY, MO, MS, NC, NV, NY, PA, SC, TN, TX, and WV.
  • Descripción del producto
    Neptune Plus (Hemostatic Pad), Part Numbers: 8870-03 || Neptune Pad is used to promote the rapid control of bleeding and provide hemostasis for lacerations, abrasions, vascular access sites and following surgical incision. It can be used to achieve hemostasis at the skin surface for arterial/venous catheterization/tubes, needle puncture, hemodialysis and in patients on anticoagulation therapy
  • Manufacturer
    TZ Medical, Inc.
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall Neptune Plus (Hemostatic Pad)
Device Recall Sterile Empty Vial (SEV)
  • Modelo / Serial
    SEV2120414, SEV2120514
  • Clasificación del producto
    General Hospital and Personal Use Devices
  • Clase de dispositivo
    Unclassified
  • ¿Implante?
    No
  • Distribución
    US Distribution to the state of : NC
  • Descripción del producto
    GREER 2 ML Sterile Empty Vials 2-13 vial 25 ea - Silver Cap
  • Manufacturer
    Allergy Laboratories, Inc.
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall Sterile Empty Vial (SEV)
Device Recall ReliaMed Silver Alginate/CMC
  • Modelo / Serial
    AMS Lot number 51594 51800 51883 51928 52023 52024 52002 52065 52230 52750 52754 52782 52775 52811 53213 53488 53532 53628 53665 53633 53981 53989 54066 01334 01263 01341 02112 02438 02583 02592 02582 02523 03138 03667 03675 03819 03908 03779 04254 04142 05996 06086 06256
  • Clasificación del producto
    General and Plastic Surgery Devices
  • Clase de dispositivo
    Unclassified
  • ¿Implante?
    No
  • Distribución
    OH
  • Descripción del producto
    ReliaMed¿ Silver Alginate/CMC. Each dressing is packed in a pouch (primary packaging), each pouch is packed in a carton (secondary packaging) holding multiple (depending on stock keeping unit) pouches and each carton contains one (1) Instructions For Use (IFU) leaflet.
  • Manufacturer
    Advanced Medical Solutions Ltd.
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall ReliaMed Silver Alginate/CMC
Device Recall ReliaMed Alginate/CMC
  • Modelo / Serial
    51593 51772 52013 52001 52074 52668 52752 52756 52810 52851 53233 53234 53467 53655 53727 53685 53769 01129 01332 01569 02390 02584 02429 03696 03813 04095 04137
  • Clasificación del producto
    General and Plastic Surgery Devices
  • Clase de dispositivo
    Unclassified
  • ¿Implante?
    No
  • Distribución
    OH
  • Descripción del producto
    ReliaMed¿ Alginate/CMC. Each dressing is packed in a pouch (primary packaging), each pouch is packed in a carton (secondary packaging) holding multiple (depending on stock keeping unit) pouches and each carton contains one (1) Instructions For Use (IFU) leaflet.
  • Manufacturer
    Advanced Medical Solutions Ltd.
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall ReliaMed Alginate/CMC
Device Recall FROWound cleanser/ Dressing, wound, drug
  • Modelo / Serial
    Lot 3045639, expiration date: 01/2018
  • Clasificación del producto
    General and Plastic Surgery Devices
  • Clase de dispositivo
    Unclassified
  • ¿Implante?
    No
  • Distribución
    Nationwide Distribution
  • Descripción del producto
    Ceramax Skin Barrier Cream: || NET WT 0.1 OZ (3 g professional sample - not for retail sale) || Under the supervision of a health care professional, Ceramax is intended to be used as a topical skin care preparation to relieve and to manage the burning and itching associated with various dermatoses including atopic dermatitis, irritant contact dermatitis, radiation dermatitis, and other dry skin conditions, by maintaining a moist wound and skin environment. || General and Plastic Surgery: Ceramax is intended to be used as a topical skin care preparation to relieve and to manage the burning and itching associated with various dermatoses including atopic dermatitis, irritant contact dermatitis, radiation dermatitis, and other dry skin conditions, by maintaining a moist wound and skin environment.
  • Manufacturer
    Oculus Innovative Sciences, Inc.
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall FROWound cleanser/ Dressing, wound, drug
Device Recall Covidien Curity Wet Dressing
  • Modelo / Serial
    Lot Number beginning with: 14, 15, 16 Expiration Date: From February 2017 through November 2019
  • Clasificación del producto
    General and Plastic Surgery Devices
  • Clase de dispositivo
    Unclassified
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution. US (Nationwide), Internationally to Canada, Australia, Brunei, Japan, Mexico, Philippines, Singapore, Andorra, Belgium, Botswana, Czech Republic, Denmark, Egypt, France, Greece, Hungary, Ireland, Israel, Italy, Kenya, Libya, Luxembourg, Mauritius, Namibia, Netherlands, Norway, Poland, Portugal, Russia, Russian Federation, Spain, Saudi Arabia, Seychelles, Slovakia, South Africa, Switzerland, UAE, and United Kingdom.
  • Descripción del producto
    Covidien Curity Wet Dressing 8 x 4 (20.3 cm x 10.2 cm), Sterile || Item Code: 3337 || Curity sodium chloride dressing is saturated in a 20% hypertonic saline solution. The dressing is designed to help promote biological cleansing within the wound and aid in the autolytic debridement process.
  • Manufacturer
    Covidien LLC
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall Covidien Curity Wet Dressing
Device Recall BD MAX System
  • Modelo / Serial
    Catalog number 441916
  • Clasificación del producto
    General Hospital and Personal Use Devices
  • Clase de dispositivo
    Unclassified
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - US Distribution to the states of : CA, CO, FL, IL, MN, MO, MT, NE, NJ, NY, OH, OR, PA, TX, TN, WA, WI., and to the countries of : Canada, Hong Kong, Taiwan, Turkey and Europe. Federal Government Agency sales/distribution centers or foreign countries VA Fort Harrison and VAMC Austin.
  • Descripción del producto
    Software version 4.44A utilized on the BD MAX System
  • Manufacturer
    BD LIFE SCIENCES
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall BD MAX System
Device Recall QuikClot TraumaPad
  • Modelo / Serial
    Lot # 7313
  • Clasificación del producto
    General and Plastic Surgery Devices
  • Clase de dispositivo
    Unclassified
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - US (Nationwide) Foreign: South Korea, Taiwan, Thailand
  • Descripción del producto
    QuikClot TraumaPad, , sterile, soft, white, X-ray detectable || hemostatic dressing || Part Number 460 || Manufactured by Z-Medica, LLC 4 Fairfield Boulevard, Wallingford, CT 06492 USA || For use as a topical dressing for local management of bleeding wounds such as cuts, lacerations, and abrasions. It may also be used for temporary treatment of severely bleeding wounds such as surgical wounds (operative, postoperative, dermatological, etc.) and traumatic injuries
  • Manufacturer
    Z-Medica, LLC
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall QuikClot TraumaPad
Device Recall SoftLab
  • Modelo / Serial
    Versions 4.5.4.3, 4.5.4.5, 4.5.4.6, 4.5.4.8, 4.5.4.9, 4.5.4.20, 4.5.4.30, 4.5.4.40, 4.5.5.0, 4.5.5.10, and 4.5.5.20
  • Clasificación del producto
    General Hospital and Personal Use Devices
  • Clase de dispositivo
    Unclassified
  • ¿Implante?
    No
  • Distribución
    US Distribution to states of: CA, IL, LA, MA, MD, MI, MN, NJ, NY, PA, and TX.
  • Descripción del producto
    SoftLab Software || Laboratory information system to be used in a medical research or clinical laboratory by knowledgeable, trained,
  • Manufacturer
    Soft Computer Consultants, Inc.
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall SoftLab
Device Recall QuikClot Trauma Pad
  • Modelo / Serial
    Part# 460, Lot# 7397
  • Clasificación del producto
    General and Plastic Surgery Devices
  • Clase de dispositivo
    Unclassified
  • ¿Implante?
    No
  • Distribución
    Nationally
  • Descripción del producto
    QuikClot TraumaPad, Part# 460 a topical dressing for local management of bleeding wounds such as cuts, lacerations, and abrasions. It may also be used for temporary treatment of severely bleeding wounds such as surgical wounds (operative, postoperative, dermatological, etc.) and traumatic injuries
  • Manufacturer
    Z-Medica, LLC
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall QuikClot Trauma Pad
Device Recall Manuka Honey Wound Gel
  • Modelo / Serial
    Lot# 1610; 1621; 1639; 1737; 1745
  • Clasificación del producto
    General and Plastic Surgery Devices
  • Clase de dispositivo
    Unclassified
  • ¿Implante?
    No
  • Distribución
    US state of RI
  • Descripción del producto
    Manuka Honey Wound Gel || Catalogue No: 716597 || Product Usage: || Helps maintain a moist wound environment which has shown to be conducive to wound healing Ideal for minor scalds and burns, minor cuts, lacerations and minor abrasions
  • Manufacturer
    Integra LifeSciences Corp.
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall Manuka Honey Wound Gel
Device Recall HARMONIC ACE Shears Adaptive Tissue Technology
  • Modelo / Serial
    P9125C,  P93T5J,  P93T5K,  P93V06,  P93W4Y,  P93Y4A,  P93W8A, P9400F,  P9409V,  P94A93,  P94A94,  P94C8R,  P94G1W,  P91F4A,  P91F86,  P93M3W,  P93W0A,  P93Z4X,  P93Z96,  P94E6U,  P94H32,  P94H9V,  P94J28
  • Clasificación del producto
    General and Plastic Surgery Devices
  • Clase de dispositivo
    Unclassified
  • ¿Implante?
    No
  • Distribución
    Worldwide distribution - US Nationwide. The devices were distributed to the following foreign countries: Algeria, Angola, Argentina, Armenia, Australia, Austria, Belgium, Bolivia, Bosnia, Brazil, Bulgaria, Canada, Chile, China, Columbia, Costa Rica, Croatia, Czech Republic, Denmark, Ecuador, Egypt, Estonia, Finland, France, French Guiana, French Polynesia, Georgia, Germany, UK, Greece, Guadeloupe, Hong Kong, Hungary, Iceland, India, Indonesia, Iran, Ireland, Israel, Italy, Jamaica, Japan, Jordan, Kazakhstan, Kenya, Korea, Latvia, Lebanon, Lithuania, Luxembourg, Malaysia, Malta, Martinique, Mayotte, Mexico, Mongolia, Montenegro, Morocco, Netherlands, Norway, Pakistan, Panama, Peru, Philippines, Poland, Portugal, Puerto Rico, Romania, Russia, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Syria, Taiwan, Thailand, Trinidad and Tobago, Turkey, Ukraine, UAE, Uruguay, Vietnam.
  • Descripción del producto
    HARMONIC ACE Shears + Adaptive Tissue Technology, 5mm Diameter / 23cm Length / Curved, Product Code HAR23, GTIN 10705036014430 || Product Usage: The HARMONIC ACE¿ Shears + Adaptive Tissue Technology are 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 in general, plastic, pediatric, gynecologic, urologic, thoracic, exposure to orthopedic structures (such as spine and joint space) and other open and endoscopic procedures.
  • Manufacturer
    Ethicon Endo-Surgery Inc
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall HARMONIC ACE Shears Adaptive Tissue Technology
Device Recall The HARMONIC ACE Shears Adaptive Tissue Technology
  • Modelo / Serial
    N93923,  N9392K,  N93978,  P9123A,  P9129W,  P91301,  P91394,  P9139N,  P9144R,  P9149J,  P9148K,  P9168K,  P9173R,  P9174K,  P91795,  P91C51,  P91C83,  P91D30,  P91K68,  P91L0H,  P91K69,  P91L0J,  P91L1Y,  P91L6E,  P91L6J,  P9396A,  P9396C,  P9399T,  P93A1L,  P93M0K,  P93M0L,  P93N01,  P93M5Y,  P93N5A,  P93N3X,  P93N3Y,  P93P09,  P93P26,  P93P7H,  P93R10,  P93R4F,  P93R4G,  P93R56,  P93R6V,  P93T0X,  P93T9L,  P93T9M,  P93U17,  P93U91,  P93V0V,  P93V0W,  P93V5T,  P93V02,  P93V03,  P93X4E,  P93X65,  P93X85,  P93X98,  P93X9E,  P93Y47,  P93Y48,  P93Y8X,  P93X2X,  P93Z95,  P93Z4T,  P93Z5X,  P94015,  P9405H,  P9409W,  P9410Z,  P9414T,  P94A5K,  P94A6A,  P94C11,  P94C47,  P94C5R,  P94C8T,  P94D3J,  P94D3K,  P94D5G,  P94D7Z,  P94D9K,  P94E1Z,  P94E20,  P94E3Z,  P94E8W,  P94F1M,  P94F3A,  P94F5T,  P94F6C,  P94F7L,  P94G1G,  P94G1H,  P94G1J,  P94H0J,  P94H0K,  P94H31,  P94H4V,  P94H8J,  P9139V,  P91749,  P9179U,  P91F2X,  P91L1Z,  P93L47,  P93L76,  P93M6T,  P93M6P,  P93N00,  P93N7G,  P93N7H,  P93P2E,  P93P7G,  P93R0Z,  P93R57,  P93R6U,  P93T20,  P93T26,  P93U0P,  P93U5N,  P93U90,  P93V57,  P93W9X,  P93X2G,  P93W9R,  P93X2W,  P94C10,  P94D0M,  P94D0P,  P94J29
  • Clasificación del producto
    General and Plastic Surgery Devices
  • Clase de dispositivo
    Unclassified
  • ¿Implante?
    No
  • Distribución
    Worldwide distribution - US Nationwide. The devices were distributed to the following foreign countries: Algeria, Angola, Argentina, Armenia, Australia, Austria, Belgium, Bolivia, Bosnia, Brazil, Bulgaria, Canada, Chile, China, Columbia, Costa Rica, Croatia, Czech Republic, Denmark, Ecuador, Egypt, Estonia, Finland, France, French Guiana, French Polynesia, Georgia, Germany, UK, Greece, Guadeloupe, Hong Kong, Hungary, Iceland, India, Indonesia, Iran, Ireland, Israel, Italy, Jamaica, Japan, Jordan, Kazakhstan, Kenya, Korea, Latvia, Lebanon, Lithuania, Luxembourg, Malaysia, Malta, Martinique, Mayotte, Mexico, Mongolia, Montenegro, Morocco, Netherlands, Norway, Pakistan, Panama, Peru, Philippines, Poland, Portugal, Puerto Rico, Romania, Russia, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Syria, Taiwan, Thailand, Trinidad and Tobago, Turkey, Ukraine, UAE, Uruguay, Vietnam.
  • Descripción del producto
    HARMONIC ACE Shears + Adaptive Tissue Technology, 5mm Diameter / 36cm Length / Curved, Product Code HAR36, GTIN 10705036014447 || Product Usage: The HARMONIC ACE¿ Shears + Adaptive Tissue Technology are 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 in general, plastic, pediatric, gynecologic, urologic, thoracic, exposure to orthopedic structures (such as spine and joint space) and other open and endoscopic procedures.
  • Manufacturer
    Ethicon Endo-Surgery Inc
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall The HARMONIC ACE Shears Adaptive Tissue Technology
Device Recall Kit containing Endopath ETSFlex Articulating Endoscopic Linear Cutter
  • Modelo / Serial
    Lot Numbers: T4VZ68, T4W30K, T4W881, T4WL7Z, T4WR5X, T4WT38, T4WY34, T4X38G, T4X52L, T4YC9J.
  • Clasificación del producto
    General and Plastic Surgery Devices
  • Clase de dispositivo
    Unclassified
  • ¿Implante?
    No
  • Distribución
    The product was shipped to hospitals and distributors located nationwide and worldwide.
  • Descripción del producto
    FlexTray Procedure Delivery System Endopath Bariatric Surgery Tray, Product #FBW24.
  • Manufacturer
    Ethicon Endo-Surgery
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall Kit containing Endopath ETSFlex Articulating Endoscopic Linear Cutter
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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.