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  • Dispositivo 128
  • Fabricante 31827
  • Evento 155
  • Implante 27
Device Recall SpineWave
  • Modelo / Serial
    Lot Codes: 092514Z, 120814A, 011415H and 022415F
  • Clasificación del producto
    Ear, Nose, and Throat Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    US Nationwide Distribution in the state of CA, FL, GA, LA, MA, MD, MI, MO, NC, NH, OH, OR, PA, TX, and VA.
  • Descripción del producto
    Spine Wave Access Kit, Catalog Number 10-1530 || Package contents: RLSP494-Rhythmlink Monopolar Stimulating Probe and 10-1525 Disposable Dilator Set. || Product Usage: || The Spine Wave Access Kit is comprised of a sterile monopolar stimulating probe (individually packaged by Rhythmlink International) and a set of three sterile disposable dilators (individually packaged by Spine Wave). The Rhythmlink International Monopolar Stimulating Instrument is indicated for stimulation of cranial and peripheral motor nerves for location and identification during surgery, including spinal nerve roots.
  • Manufacturer
    Spine Wave, Inc.
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall SpineWave
Device Recall E.N.T. PK
  • Modelo / Serial
    Code:9001482 Lots: 140915232 exp. 11/30/15 141216408 exp. 12/31/15 150116993 exp. 2/28/16 150217269 exp. 2/28/16 150518643 exp. 5/31/16 150317602 exp. 5/31/16
  • Clasificación del producto
    Ear, Nose, and Throat Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Distributed Only in Puerto Rico.
  • Descripción del producto
    E.N.T. PK 7/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 E.N.T. PK
Device Recall EAR PACK
  • Modelo / Serial
    Code:9002234 Lots: 141015704 exp. 12/31/15 141216300 exp. 12/31/15 140915246 exp. 12/31/15 150217385 exp. 2/28/16 150317727 exp. 4/30/16 150418353 exp. 4/30/16 150418353 exp. 4/30/16 150518688 exp. 5/31/16 150619252 exp. 6/30/16
  • Clasificación del producto
    Ear, Nose, and Throat Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Distributed Only in Puerto Rico.
  • Descripción del producto
    EAR PACK 3/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 EAR PACK
Device Recall EAR PACK
  • Modelo / Serial
    Code:9002423 Lots: 141015705 exp. 12/31/15 141216302 exp. 2/28/16 150518811 exp. 5/31/16
  • Clasificación del producto
    Ear, Nose, and Throat Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Distributed Only in Puerto Rico.
  • Descripción del producto
    EAR PACK 3/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 EAR PACK
Device Recall EENT PACK I
  • Modelo / Serial
    Code:9002498 Lots: 150116588 exp. 1/31/16 150116586 exp. 1/31/16 150116587 exp. 1/31/16
  • Clasificación del producto
    Ear, Nose, and Throat Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Distributed Only in Puerto Rico.
  • Descripción del producto
    EENT PACK I (1) 10/CS CUSTOMED || 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 EENT PACK I
Device Recall Customed
  • Modelo / Serial
    LOTS: SL15201-01 (150719645) 31-JUL-16 SL15222 (150719959) 30-JUN-16 SL15223 (150719959) 30-JUN-16
  • Clasificación del producto
    Ear, Nose, and Throat Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Distributed only in Puerto Rico.
  • Descripción del producto
    Catalog Number: 9001482 || ENT SURGICAL PACK || 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 Customed
Device Recall OCM Cutting Burrs (Cutters)
  • Modelo / Serial
    Model/Catalog #:OCM7-15SD, 1.5 MM Diamond Ball, Lot Numbers: J473111704 and J473111705
  • Clasificación del producto
    Ear, Nose, and Throat Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    US Distribution in the states of KY and TX.
  • Descripción del producto
    ANSPACH, Rx only, Otologic Curved Micro (OCCM) Diamond Ball Burr, 1.5 MM, Part # OCM7-15SD || Product Usage: || The Otologic Curved Micro (OCCM) Attachment and burrs are intended for cutting and shaping bone primarily in otology procedures such as cochleostomies.
  • Manufacturer
    The Anspach Effort, Inc.
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall OCM Cutting Burrs (Cutters)
Device Recall OCM Cutting Burrs (Cutters)
  • Modelo / Serial
    Model/Catalog #: OCM7-2SD, 2.0 MM Diamond Ball, Lot Numbers: J473111699.
  • Clasificación del producto
    Ear, Nose, and Throat Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    US Distribution in the states of KY and TX.
  • Descripción del producto
    ANSPACH, Rx only, Otologic Curved Micro (OCCM) Diamond Ball Burr, 2.0 MM, Part # OCM7-2SD || Product Usage: || The Otologic Curved Micro (OCCM) Attachment and burrs are intended for cutting and shaping bone primarily in otology procedures such as cochleostomies.
  • Manufacturer
    The Anspach Effort, Inc.
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall OCM Cutting Burrs (Cutters)
Device Recall Cytosponge Cell Collection Device
  • Modelo / Serial
    Item Code: CYTO-KIT-R; Lot numbers: 3441120915, 3441102015
  • Clasificación del producto
    Ear, Nose, and Throat Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution-US Distribution to TN, NC, IL, CA, MN, OR and NY; and countries of: United Kingdom and Iran.
  • Descripción del producto
    Covidien Cytosponge Cell Collection Kit. || Contains Cytosponge Cell Collection Device, Specimen Jar with preservative. || Item code CYTO-KIT-R || Gastroenterology: Cytosponge Cell Collection Device is indicated for use in the collection and retrieval of surface cells in the esophagus. Currently the device is only available for clinical studies.
  • Manufacturer
    Covidien, LLC
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall Cytosponge Cell Collection Device
Device Recall Cytosponge Cell Collection Device
  • Modelo / Serial
    Item Code: CYTO-101-01. Lot numbers: F2500566X, F2500628X, F2500202X, F2500351X.
  • Clasificación del producto
    Ear, Nose, and Throat Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution-US Distribution to TN, NC, IL, CA, MN, OR and NY; and countries of: United Kingdom and Iran.
  • Descripción del producto
    Covidien Cytosponge Cell Collection Device. || Item code CYTO-101-01. || Gastroenterology: -.Cytosponge Cell Collection Device is indicated for use in the collection and retrieval of surface cells in the esophagus. This device is currently only being used in clinical studies.
  • Manufacturer
    Covidien, LLC
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall Cytosponge Cell Collection Device
Device Recall endotrachial tube
  • Modelo / Serial
    All lots distributed since May 2012. Catalog Ref No. (reinforced standard tubes) 82-29306, 82-29307, & 82-29308; Catalog Ref No. (reinforced standard tubes, Japan) 8229306J, 8229307J, & 8229308J; Catalot Ref No. (reinforced contact tubes) 8229506, 8229507, & 8229508;
  • Clasificación del producto
    Ear, Nose, and Throat Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - Nationwide Distribution including US Virgin Island and Puerto Rico , and to the countries of :Japan, Korea, China, Canada, Dominican Republic, Colombia, Chile, Costa Rica, Bahamas, Peru, Panama, Mexico, Argentina, Ecuador, Brazil, Trinidad and Tobago, Hong Kong, Taiwan, United Kingdom, Netherlands, Sri Lanka, Austria, Italy, Germany, United Arab Emirates, Saudi Arabia, Kuwait, France, Belgium, Oman, Ireland, Azerbaijan, India, Spain, Portugal, Luxembourg, Switzerland, Russian Federation, Austria, Greece, Cyprus, Portugal, India, Algeria, Iceland, Iran, Denmark, Hungary, Czech Republic, Ukraine, Turkey, Croatia, Israel, Norway, Oman, Sweden, Libya, Finland, Spain, Portugal, Algeria, Morocco, Poland, Canada, Malaysia, Singapore, Australia, and New Zealand
  • Descripción del producto
    NIM EMG Endotracheal Tube, 6.0 mm I.D. x 8.8 mm O.D. (27 FR), Reinforced, Sterile, Rx only. Individually packaged.
  • Manufacturer
    Medtronic Xomed, Inc.
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall endotrachial tube
Device Recall Pentax
  • Modelo / Serial
    EB-1170K; EB-1570K; EB-1575K; EB=1970K; EB-1970TK; EB-1975K
  • Clasificación del producto
    Ear, Nose, and Throat Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Nationwide Distribution
  • Descripción del producto
    Pentax Video Bronchoscope || Designed to be used with a Pentax Video Processor (including light source), documentation equipment, video monitor, endo-therapy accessories (such as biopsy forceps) and other ancillary equipment for endoscopy and endoscopic surgery within the airways and tracheobronchial tree.
  • Manufacturer
    Pentax of America Inc
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall Pentax
Device Recall Pentax Inc
  • Modelo / Serial
    EB-1970UK
  • Clasificación del producto
    Ear, Nose, and Throat Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Nationwide Distribution
  • Descripción del producto
    Ultrasound Video Bronchoscope || The EB-1970UK, Ultrasound Video Bronchoscope, is intended to provide optical visualization of, ultrasonic visualization of, and therapeutic access to, the Pulmonary Track including but not restricted to organs, tissues, and subsystem: Nasal Passage, Pharynx, Larynx, Trachea, Bronchial Tree (including access beyond the stem), and underlying areas. The instrument is introduced per orally when indications consistent with the requirement for procedure are observed in adult and pediatric patient populations.
  • Manufacturer
    Pentax of America Inc
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall Pentax Inc
Device Recall Pentax Rigid Laryngostroboscopes
  • Modelo / Serial
    Model #'s 9106 and 9108
  • Clasificación del producto
    Ear, Nose, and Throat Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution-US (nationwide) and countries of: Albania, Australia, Belgium, Brazil, Bulgaria, Canada, Chile, Croatia, Denmark, Ecuador, Egypt, Finland, France, Germany, Hong Kong, India, Ireland, Israel, Italy, Japan, Kuwait, Lebanon, Lithuania, Malaysia, Mexico, Netherlands, New Zealand, Oman, Philippines, Portugal, Saudi Arabia, Singapore, South Africa, South Korea, Spain, Sweden, Taiwan, Thailand, Trinidad, Turkey, United Arab Emirates, and United Kingdom.
  • Descripción del producto
    Rigid Laryngostroboscopes || The Rigid Laryngostroboscopes, Models 9106 and 9108 are intended to observe glottic action with the use of a stroboscopic light source. The instrument is inserted per-orally when indications consistent with the need for observation are observed.
  • Manufacturer
    Pentax of America Inc
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall Pentax Rigid Laryngostroboscopes
Device Recall Stryker PROFESS
  • Modelo / Serial
    Lot #202085 Stryker Product Number: 6001-420-000
  • Clasificación del producto
    Ear, Nose, and Throat Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    US (nationwide) Distribution to the states of : CA, CT, GA, IL, IN, MA, MD, NC, OH, PA, TN, and TX.
  • Descripción del producto
    Stryker PROFESS Registration Kit. || The Stryker PROFESS Registration Kit is a member of the Navigation portfolio and is used as an intraoperative guidance system to enable intranasal and sinus computer-assisted surgery. The system is comprised of PROFESS Registration Stickers, a PROFESS Patient Tracker, and a PROFESS Adaptor Cable.
  • Manufacturer
    Stryker Instruments Div. of Stryker Corporation
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall Stryker PROFESS
Device Recall Pentax
  • Modelo / Serial
    Model #'s: EB-1170K, EB-1570, EB-1570AK, EB-1570K, EB-1970AK, EB-1970K, EB-1970TK and EB-1970UK
  • Clasificación del producto
    Ear, Nose, and Throat Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    US Nationwide and Internationally
  • Descripción del producto
    Video Bronchoscope
  • Manufacturer
    Pentax of America Inc
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall Pentax
Device Recall Pentax
  • Modelo / Serial
    Model #'s:ECY-1570 and ECY-1570K
  • Clasificación del producto
    Ear, Nose, and Throat Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    US Nationwide and Internationally
  • Descripción del producto
    Video Cytoscopes
  • Manufacturer
    Pentax of America Inc
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall Pentax
Device Recall Pentax
  • Modelo / Serial
    Model #: VNL-1570STK
  • Clasificación del producto
    Ear, Nose, and Throat Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    US Nationwide and Internationally
  • Descripción del producto
    Video Naso pharyngo Laryngoscopes
  • Manufacturer
    Pentax of America Inc
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall Pentax
Device Recall Medtronic Straight Suction
  • Modelo / Serial
    Lot numbers 17022809, 17030108,17022207,17022106, 17020805, 17020904, 17021798,17020987, 17011896, 17011221, 17011220, 16122237, 16122236, 16121661,16121260, 16121259, and 16112958
  • Clasificación del producto
    Ear, Nose, and Throat Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - US (nationwide) and Internationally to Canada.
  • Descripción del producto
    Medtronic Straight Suction 9733449 EM ENT, reusable, Rx. The firm name on the label is Medtronic Navigation, Inc., Louisville, CO. || The suction devices are part of a family of reusable ENT instruments that are used with the StealthStationTM AxiEM surgical navigation system. The AxiEM system is an electromagnetic (EM) tracking solution for surgical tools. The system measures an induced voltage created by local magnetic fields from a set of coils in the transmit coil array (TCA). Each surgical tool has a set of receiving coils to sense the magnetic field strength. Using a mathematical algorithm, the position and orientation of the instrument can be computed and overlaid/registered to imagery on a computer monitor, resulting in the ability to track the instrument tip in relation to the patients anatomy. AxiEM ENT Suction devices are used as suction and pointing devices. The suction devices are intended to have an ENT Instrument Tracker mounted on it
  • Manufacturer
    Medtronic Navigation, Inc.
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall Medtronic Straight Suction
Device Recall Medtronic Curved Suction 70
  • Modelo / Serial
    Lot numbers 17030722, 17022421,17022020, 17020619, 17011918, 17012417, I 17010602, 16122724,16122239, 16122038, 16120563, and 16112362
  • Clasificación del producto
    Ear, Nose, and Throat Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - US (nationwide) and Internationally to Canada.
  • Descripción del producto
    Medtronic Curved Suction 70 9733450 EM ENT, reusable, Rx. The firm name on the label is Medtronic Navigation, Inc., Louisville, CO. || The suction devices are part of a family of reusable ENT instruments that are used with the StealthStationTM AxiEM surgical navigation system. The AxiEM system is an electromagnetic (EM) tracking solution for surgical tools. The system measures an induced voltage created by local magnetic fields from a set of coils in the transmit coil array (TCA). Each surgical tool has a set of receiving coils to sense the magnetic field strength. Using a mathematical algorithm, the position and orientation of the instrument can be computed and overlaid/registered to imagery on a computer monitor, resulting in the ability to track the instrument tip in relation to the patients anatomy. AxiEM ENT Suction devices are used as suction and pointing devices. The suction devices are intended to have an ENT Instrument Tracker mounted on it
  • Manufacturer
    Medtronic Navigation, Inc.
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall Medtronic Curved Suction 70
Device Recall Medtronic Curved Suction 90
  • Modelo / Serial
    Lot numbers 17030728, 17022027, 17021426, 17013125, 17012724, 17011303, 16122767, 16122066, 16112965, and 16112164
  • Clasificación del producto
    Ear, Nose, and Throat Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - US (nationwide) and Internationally to Canada.
  • Descripción del producto
    Medtronic Curved Suction 90 9733451 EM ENT, reusable, Rx. The firm name on the label is Medtronic Navigation, Inc., Louisville, CO. || The suction devices are part of a family of reusable ENT instruments that are used with the StealthStationTM AxiEM surgical navigation system. The AxiEM system is an electromagnetic (EM) tracking solution for surgical tools. The system measures an induced voltage created by local magnetic fields from a set of coils in the transmit coil array (TCA). Each surgical tool has a set of receiving coils to sense the magnetic field strength. Using a mathematical algorithm, the position and orientation of the instrument can be computed and overlaid/registered to imagery on a computer monitor, resulting in the ability to track the instrument tip in relation to the patients anatomy. AxiEM ENT Suction devices are used as suction and pointing devices. The suction devices are intended to have an ENT Instrument Tracker mounted on it
  • Manufacturer
    Medtronic Navigation, Inc.
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall Medtronic Curved Suction 90
Device Recall Medtronic Suction Small AxiEM ENT
  • Modelo / Serial
    Lot numbers 17022451,17011750, 16120349, 16082989, 16081888, 16071987, 16062713, and 16060712
  • Clasificación del producto
    Ear, Nose, and Throat Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - US (nationwide) and Internationally to Canada.
  • Descripción del producto
    Medtronic Suction 9734308 Small AxiEM ENT, reusable, Rx. The firm name on the label is Medtronic Navigation, Inc., Louisville, CO. || The suction devices are part of a family of reusable ENT instruments that are used with the StealthStationTM AxiEM surgical navigation system. The AxiEM system is an electromagnetic (EM) tracking solution for surgical tools. The system measures an induced voltage created by local magnetic fields from a set of coils in the transmit coil array (TCA). Each surgical tool has a set of receiving coils to sense the magnetic field strength. Using a mathematical algorithm, the position and orientation of the instrument can be computed and overlaid/registered to imagery on a computer monitor, resulting in the ability to track the instrument tip in relation to the patients anatomy. AxiEM ENT Suction devices are used as suction and pointing devices. The suction devices are intended to have an ENT Instrument Tracker mounted on it
  • Manufacturer
    Medtronic Navigation, Inc.
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall Medtronic Suction Small AxiEM ENT
Device Recall Medtronic Instrument Set EM ENT
  • Modelo / Serial
    Each of the devices within the kit are labeled with information specific to each of the reusable devices within the kit and those devices are what goes into the customer inventory. The outer box where the lot number is printed is discarded by the customer on receipt and the separate devices within the box are what is stored on the shelf. Therefore, no kit lot number is being provided.
  • Clasificación del producto
    Ear, Nose, and Throat Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - US (nationwide) and Internationally to Canada.
  • Descripción del producto
    Medtronic Instrument Set EM ENT, Ref. #9733452 and #9733452-G02, reusable, RX. This kit contains 9733449, Straight Suction, 9733450, 70 deg Curved Suction, and 9733451, 90 deg Curved Suction. The firm name on the label is Medtronic Navigation, Inc., Louisville, CO. || The suction devices are part of a family of reusable ENT instruments that are used with the StealthStationTM AxiEM surgical navigation system. The AxiEM system is an electromagnetic (EM) tracking solution for surgical tools. The system measures an induced voltage created by local magnetic fields from a set of coils in the transmit coil array (TCA). Each surgical tool has a set of receiving coils to sense the magnetic field strength. Using a mathematical algorithm, the position and orientation of the instrument can be computed and overlaid/registered to imagery on a computer monitor, resulting in the ability to track the instrument tip in relation to the patients anatomy. AxiEM ENT Suction devices are used as suction and pointing devices. The suction devices are intended to have an ENT Instrument Tracker mounted on it
  • Manufacturer
    Medtronic Navigation, Inc.
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall Medtronic Instrument Set EM ENT
Device Recall Medtronic Instrument Kit Fusion ENT
  • Modelo / Serial
    Each of the devices within the kit are labeled with information specific to each of the reusable devices within the kit and those devices are what goes into the customer inventory. The outer box where the lot number is printed is discarded by the customer on receipt and the separate devices within the box are what is stored on the shelf. Therefore, no kit lot number is being provided.
  • Clasificación del producto
    Ear, Nose, and Throat Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - US (nationwide) and Internationally to Canada.
  • Descripción del producto
    Medtronic Instrument Kit 9733908 Fusion ENT, reusable, RX. This kit includes Kit 9733452 (containing 9733449, Straight Suction, 9733450, 70 deg Curved Suction, and 9733451, 90 deg Curved Suction). The firm name on the label is Medtronic Navigation, Inc., Louisville, CO. || The suction devices are part of a family of reusable ENT instruments that are used with the StealthStationTM AxiEM surgical navigation system. The AxiEM system is an electromagnetic (EM) tracking solution for surgical tools. The system measures an induced voltage created by local magnetic fields from a set of coils in the transmit coil array (TCA). Each surgical tool has a set of receiving coils to sense the magnetic field strength. Using a mathematical algorithm, the position and orientation of the instrument can be computed and overlaid/registered to imagery on a computer monitor, resulting in the ability to track the instrument tip in relation to the patients anatomy. AxiEM ENT Suction devices are used as suction and pointing devices. The suction devices are intended to have an ENT Instrument Tracker mounted on it
  • Manufacturer
    Medtronic Navigation, Inc.
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall Medtronic Instrument Kit Fusion ENT
Device Recall Medtronic Set Supplemental INS AxiEM ENT
  • Modelo / Serial
    Each of the devices within the kit are labeled with information specific to each of the reusable devices within the kit and those devices are what goes into the customer inventory. The outer box where the lot number is printed is discarded by the customer on receipt and the separate devices within the box are what is stored on the shelf. Therefore, no kit lot number is being provided.
  • Clasificación del producto
    Ear, Nose, and Throat Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - US (nationwide) and Internationally to Canada.
  • Descripción del producto
    Medtronic Set Supplemental INS AxiEM ENT, Ref. 9734378, reusable, RX. This kit contains 9734308, Small Straight suction. The firm name on the label is Medtronic Navigation, Inc., Louisville, CO. || The suction devices are part of a family of reusable ENT instruments that are used with the StealthStationTM AxiEM surgical navigation system. The AxiEM system is an electromagnetic (EM) tracking solution for surgical tools. The system measures an induced voltage created by local magnetic fields from a set of coils in the transmit coil array (TCA). Each surgical tool has a set of receiving coils to sense the magnetic field strength. Using a mathematical algorithm, the position and orientation of the instrument can be computed and overlaid/registered to imagery on a computer monitor, resulting in the ability to track the instrument tip in relation to the patients anatomy. AxiEM ENT Suction devices are used as suction and pointing devices. The suction devices are intended to have an ENT Instrument Tracker mounted on it
  • Manufacturer
    Medtronic Navigation, Inc.
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall Medtronic Set Supplemental INS AxiEM ENT
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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.