Medtronic

  • Modèle / numéro de série
    Lot Numbers: 182212
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Nationwide Foreign: Austria, Australia, Bahrain, Bulgaria, Canada, Czech Republic, Denmark, Germany, Hungary, Italy, Jordan, France, Greece, Japan, Hong Kong, India, Italy, Norway, Poland, Portugal, Saudi Arabia, Spain, Sweden, Switzerland, UK.
  • Description du dispositif
    CATH.GUIDE 8F EBU 4.5 SH 110CM || CATHETER LA8EBU45SHA LA 8F 110CM EB45 Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are introduced into the coronary or peripheral vascular system. || Product Number: LA8EBU45SHA
  • Manufacturer
  • 1 Event

Fabricant

  • Adresse du fabricant
    Medtronic, Inc., 35 -37A Cherry Hill Dr, Danvers MA 01923-2565
  • Source
    USFDA

829 dispositifs médicaux avec un nom similaire

En savoir plus sur les données ici

  • Modèle / numéro de série
    Lot numbers 17022809, 17030108,17022207,17022106, 17020805, 17020904, 17021798,17020987, 17011896, 17011221, 17011220, 16122237, 16122236, 16121661,16121260, 16121259, and 16112958
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution - US (nationwide) and Internationally to Canada.
  • Description du dispositif
    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
  • Modèle / numéro de série
    Lot numbers 17030722, 17022421,17022020, 17020619, 17011918, 17012417, I 17010602, 16122724,16122239, 16122038, 16120563, and 16112362
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution - US (nationwide) and Internationally to Canada.
  • Description du dispositif
    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
  • Modèle / numéro de série
    Lot numbers 17030728, 17022027, 17021426, 17013125, 17012724, 17011303, 16122767, 16122066, 16112965, and 16112164
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution - US (nationwide) and Internationally to Canada.
  • Description du dispositif
    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
  • Modèle / numéro de série
    Lot numbers 17022451,17011750, 16120349, 16082989, 16081888, 16071987, 16062713, and 16060712
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution - US (nationwide) and Internationally to Canada.
  • Description du dispositif
    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
  • Modèle / numéro de série
    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.
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution - US (nationwide) and Internationally to Canada.
  • Description du dispositif
    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
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