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Medtronic Xomed, Inc.

31 FDA 510(k) clearances · Recalling firm

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RecordFirmDate
IPC Powerease System REF 2300000 UDI-DI: 00613994448705 00643169406834. The IPC POWEREASE recall (Z-2461-2025)Medtronic Xomed, Inc.2025-08-27
NIM Vital Nerve Monitoring System: CONSOLE NIM4CM01 NIM 4.0, REF: NIM4CM01; CONSOLE NIM4CM recall (Z-1623-2025)Medtronic Xomed, Inc.2025-04-18
Medtronic ENT Ultra Round Steel Cutting Bur, Model Number REF 31313069 recall (Z-3130-2024)Medtronic Xomed, Inc.2024-09-12
NIM Vital Nerve Monitoring systems (all serial numbers manufactured) with NIM Vital System recall (Z-2409-2024)Medtronic Xomed, Inc.2024-07-24
NIM TriVantage EMG Endotracheal Tubes, Model (REF) Numbers and sizes: a) 8229706, 6.0MM ID recall (Z-0696-2024)Medtronic Xomed, Inc.2024-01-10
NIM CONTACT EMG Endotracheal Tube, Part Numbers: a) REF 8229508 b) REF 8229507 c) REF 8229 recall (Z-1519-2022)Medtronic Xomed, Inc.2022-09-01
NIM EMG Endotracheal Tube, Part Numbers: a) REF 8229308 b) REF 8229307 c) REF 8229306 recall (Z-1520-2022)Medtronic Xomed, Inc.2022-09-01
NIM EMG Endotracheal Tube, Part Numbers: a) REF 8229307J b) REF 8229308J c) REF 8229306J recall (Z-1521-2022)Medtronic Xomed, Inc.2022-09-01
NIM Vital Console 4.0 (P/N: NIM4CM01) NIM with Software version 1.3.2 recall (Z-1223-2022)Medtronic Xomed, Inc.2022-06-02
NIM Vital Patient Interface 4.0 (P/N: NIM4CPB1) NIM with Software version 1.3.2 recall (Z-1224-2022)Medtronic Xomed, Inc.2022-06-02
Medtronic sterile single-use blades that are components of the StraightShot M Series Handp recall (Z-0156-2022)Medtronic Xomed, Inc.2021-10-21
Medtronic sterile single-use blades that are components of the StraightShot M Series Handp recall (Z-0157-2022)Medtronic Xomed, Inc.2021-10-21
Medtronic Sterile single-use blades that are components of the StraightShot M Series Handp recall (Z-0158-2022)Medtronic Xomed, Inc.2021-10-21
Universal Titanium Prosthesis, Round Head, with Flex H/A titanium shoe. The ear prosthesis recall (Z-2284-2013)Medtronic Xomed, Inc.2013-09-26
Tray Surgical, ENT (various instrument trays) Used for stot age and transportation of reus recall (Z-1934-2013)Medtronic Xomed, Inc.2013-08-09
REF 8229705 x1 NIM TriVantage EMG Endotracheal Tube 5.0 mm I.D. x 6.5 mm O.D. Medtronic Xo recall (Z-1420-2013)Medtronic Xomed, Inc.2013-06-04
Interfaces subject to recall: Medtronic NIM (Nerve Integrity Monitor) 3.0 Patient Interfac recall (Z-2342-2012)Medtronic Xomed, Inc.2012-09-10
Interfaces subject to recall: Medtronic NIM (Nerve Integrity Monitor) 3.0 Patient Interfac recall (Z-2343-2012)Medtronic Xomed, Inc.2012-09-10
Interfaces subject to recall: Medtronic NIM (Nerve Integrity Monitor) 3.0 Patient Interfac recall (Z-2344-2012)Medtronic Xomed, Inc.2012-09-10
An external nasal splint is a rigid or partially rigid device intended for the use externa recall (Z-1699-2011)Medtronic Xomed, Inc.2011-03-17
Recall of Alcohol Pads contained in the following kits distributed by Medtronic: ***REF 15 recall (Z-1700-2011)Medtronic Xomed, Inc.2011-03-17
Repose G2 Bone Screw System, Sterile, REF 76353200; Lot # 62450300. Distributed by Medtron recall (Z-0535-2010)Medtronic Xomed, Inc.2009-12-15
Repose G2 Bone Screw, Sterile, REF 76310200, Lot # 62450200. Distributed by Medtronic Xome recall (Z-0536-2010)Medtronic Xomed, Inc.2009-12-15
Medtronic Integrated Power Console System, IP X1 REF 1898001 or REF EC300 Medtronic Xomed, recall (Z-0259-2010)Medtronic Xomed, Inc.2009-11-13
VARI-STIM III Nerve Locator/Stimulator, Sterile, Medtronic Xomed, Inc. The Vari-Stim III n recall (Z-0947-2009)Medtronic Xomed, Inc.2009-03-03
AccuGuide Injection Needles (Surface electrodes) The AccuGuide EMG Injection Needle, produ recall (Z-0576-2007)Medtronic Xomed, Inc.2007-03-07
Brand name: NIM EMG Endotracheal Tube REF 82-29106, 82-29107, 82-29108 NIM EMG Reinforced recall (Z-0310-05)Medtronic Xomed, Inc.2004-12-15
Product is a surgical nasal/sinus surgical device labeled as a RAD Frontal Finesse Bur, Re recall (Z-0953-04)Medtronic Xomed, Inc.2004-07-20
The product is a sheath meant to fit over a Nasopharyngoscope and is labeled as EndoScrub recall (Z-0954-04)Medtronic Xomed, Inc.2004-07-20
Product is a device used in adenoid surgery and is labeled as Lusk Disposable Adenoid Cure recall (Z-0955-04)Medtronic Xomed, Inc.2004-07-20
Product is labeled as ''Oto-''Flex Bur'', Medtronic-Xomed brand, packed into a sterile pou recall (Z-0662-03)Medtronic Xomed, Inc.2003-03-20

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