Medtronic 9734378

• EUDAMED Basic UDI-DI 0763000B00007968Q registered 17 Jul 2026 Active
• FDA 510(k) K001284 decided 12 Jun 2000 Active
• FDA GUDID UDI-DI 00763000811129 listed 7 Jun 2026 Listed

• 2 recalls, same reason

  • Terminated Z-2317-2016 FDA Class II ·initiated 18 Jul 2016
  • Terminated Z-2319-2016 FDA Class II ·initiated 18 Jul 2016

  Medtronic Navigation, Inc. announces a voluntary field action for the Medtronic Navigation StealthStation Software applications affected by Neurologica BodyTom/CereTom floor-based scanners.

• 25 recalls, same reason

  • Terminated Z-1587-2014 FDA Class II ·initiated 24 Apr 2014
  • Terminated Z-1581-2014 FDA Class II ·initiated 24 Apr 2014
  • Terminated Z-1582-2014 FDA Class II ·initiated 24 Apr 2014
  • Terminated Z-1600-2014 FDA Class II ·initiated 24 Apr 2014
  • Terminated Z-1584-2014 FDA Class II ·initiated 24 Apr 2014
  • Terminated Z-1601-2014 FDA Class II ·initiated 24 Apr 2014
  • Terminated Z-1578-2014 FDA Class II ·initiated 24 Apr 2014
  • Terminated Z-1580-2014 FDA Class II ·initiated 24 Apr 2014
  • Terminated Z-1591-2014 FDA Class II ·initiated 24 Apr 2014
  • Terminated Z-1590-2014 FDA Class II ·initiated 24 Apr 2014
  • Terminated Z-1595-2014 FDA Class II ·initiated 24 Apr 2014
  • Terminated Z-1594-2014 FDA Class II ·initiated 24 Apr 2014
  • Terminated Z-1593-2014 FDA Class II ·initiated 24 Apr 2014
  • Terminated Z-1596-2014 FDA Class II ·initiated 24 Apr 2014
  • Terminated Z-1598-2014 FDA Class II ·initiated 24 Apr 2014
  • Terminated Z-1592-2014 FDA Class II ·initiated 24 Apr 2014
  • Terminated Z-1589-2014 FDA Class II ·initiated 24 Apr 2014
  • Terminated Z-1585-2014 FDA Class II ·initiated 24 Apr 2014
  • Terminated Z-1579-2014 FDA Class II ·initiated 24 Apr 2014
  • Terminated Z-1602-2014 FDA Class II ·initiated 24 Apr 2014
  • Terminated Z-1583-2014 FDA Class II ·initiated 24 Apr 2014 ·on shared 510(k) K001284
  • Terminated Z-1599-2014 FDA Class II ·initiated 24 Apr 2014
  • Terminated Z-1588-2014 FDA Class II ·initiated 24 Apr 2014 ·on shared 510(k) K001284
  • Terminated Z-1597-2014 FDA Class II ·initiated 24 Apr 2014
  • Terminated Z-1586-2014 FDA Class II ·initiated 24 Apr 2014

  Medtronic Navigation is recalling certain Medtronic single-use, disposable devices because there was not sufficient control to assure that returned, unused devices were appropriately examined for product and/or package damage to ensure sterility.

• • Terminated Z-0718-06 FDA Unclassified (pre-2012) ·initiated 1 Feb 2006

  Knee Navigation Disposable Kits were programmed with an incorrect identification number on the tracker ROM chip which would not permit navigation during surgery.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

1. 24 Apr 2014 Recall initiated FDA recalls Z-1602-2014
2. 24 Apr 2014 Recall initiated FDA recalls Z-1583-2014
3. 24 Apr 2014 Recall initiated FDA recalls Z-1599-2014
4. 24 Apr 2014 Recall initiated FDA recalls Z-1588-2014
5. 24 Apr 2014 Recall initiated FDA recalls Z-1597-2014
6. 24 Apr 2014 Recall initiated FDA recalls Z-1586-2014
7. 18 Jul 2016 Recall initiated FDA recalls Z-2317-2016
8. 18 Jul 2016 Recall initiated FDA recalls Z-2319-2016
9. 7 Jun 2026 Listed FDA GUDID 00763000811129
10. 17 Jul 2026 Registered EUDAMED 0763000B00007968Q

21 earlier events are in the sections above.

Trade name

Medtronic

Generic name

Stereotactic surgery system probe, reusable

Device name

AxiEM ENT Instruments

Model / reference

9734378

Primary DI / UDI-DI

00763000811129

Basic UDI-DI

0763000B00007968Q

510(k) Number

K001284 ↗

FDA product code

HAW

EMDN code

Z12140580 Stereotactic ENT surgery instruments - hardware accessories

GMDN term

Stereotactic surgery system probe, reusable

Device class

Class IIa EUDAMED

Class II GUDID

Regulation number

882.4560

System or procedure pack

Procedure pack

EU registration type

System or procedure pack

Medical purpose

Допълнителни електромагнитни инструменти, използвани при компютърно-асистирана УНГ хирургия

GUDID distribution status

In Commercial Distribution

Sterilisation method

Moist Heat or Steam Sterilization

Device class is stated on each registry's own scale: Class IIa in the EU (EUDAMED), Class II in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

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• Non-Invasive Patient Tracker

  Class I

  CE/MDR

• Autoguide System

  Class I

  CE/MDR

• Tactile Probe

  Class I

  CE/MDR

• Universal Drill Guides

  Class I

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See all devices from Medtronic Navigation Inc. →