Company · US
Medtronic Xomed, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 1996 to 2026. Name variants (Inc, Corp, punctuation) are merged.
47510(k) clearances (2 in 12 months)
38recalls (0 in 12 months)
25recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| ETN | Stimulator, Nerve | 19 |
| ERL | Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece | 11 |
| GWF | Stimulator, Electrical, Evoked Response | 9 |
| EQJ | Bur, Ear, Nose And Throat | 4 |
| HBE | Drills, Burrs, Trephines & Accessories (Simple, Powered) | 4 |
| LRK | Device, Anti-Snoring | 4 |
| LOB | Dilator, Cervical, Synthetic, Osmotic, Pregnancy Termination | 3 |
| EPP | Splint, Nasal | 2 |
| ETD | Tube, Tympanostomy | 2 |
| LRC | Instrument, Ent Manual Surgical | 2 |
| LYA | Splint, Intranasal Septal | 2 |
| DXC | Clamp, Vascular | 1 |
| EOB | Nasopharyngoscope (Flexible Or Rigid) | 1 |
| ETA | Replacement, Ossicular Prosthesis, Total | 1 |
| FED | Endoscopic Access Overtube, Gastroenterology-Urology | 1 |
| FST | Light, Surgical, Fiberoptic | 1 |
| GAT | Suture, Nonabsorbable, Synthetic, Polyethylene | 1 |
| GCJ | Laparoscope, General & Plastic Surgery | 1 |
| GFF | Bur, Surgical, General & Plastic Surgery | 1 |
| GXZ | Electrode, Needle | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Sep 4, 2026 | K262235 | ApexCut Blade with Automated EM Tracking (187BL4012EM);ApexCut Blade with Automated EM Tracking (187BL4040EM);ApexCu Medtronic Xomed, Inc. | PGW |
| Feb 10, 2026 | K251672 | NIM Essence EMG Endotracheal Tube (NIMEID060); NIM Essence EMG Endotracheal Tube (NIMEID065); NIM Essence EMG Endotra Medtronic Xomed, Inc. | ETN |
| Oct 26, 2023 | K230320 | NIM Standard Reinforced EMG Endotracheal Tube; CONTACT Reinforced EMG Endotracheal Tube Medtronic Xomed, Inc. | ETN |
| Aug 30, 2023 | K231580 | NIM 35cm long Surgeon Control Probe, 1mm Ball-Tip (NIMDTP35) Medtronic Xomed, Inc. | ETN |
| Mar 21, 2022 | K213246 | NIM Surgeon Control Probe, Prass Tip, NIM Surgeon Control Probe, 1mm Ball Tip, NIM Surgeon Control Probe, 1mm Ball Tip, Medtronic Xomed, Inc. | ETN |
| Aug 16, 2021 | K210841 | NuVent Eustachian Tube Dilation Balloon Medtronic Xomed, Inc. | PNZ |
| Dec 8, 2020 | K202623 | Novapak Nasal Sinus Packing and Stent Medtronic Xomed | LYA |
| Oct 28, 2020 | K200759 | NIM Vital, Nerve Integrity Monitor Medtronic Xomed, Inc. | GWF |
| Apr 20, 2018 | K173855 | Sharpsite AC Rigid Endsocope Medtronic Xomed, Inc. | EOB |
| Dec 1, 2015 | K152121 | NuVent EM Sinus Dilation System Medtronic Xomed, Inc. | LRC |
| Oct 29, 2015 | K151758 | ALAR Nasal Valve Stent Medtronic Xomed, Inc. | GAT |
| Aug 14, 2015 | K150728 | XPS Nexus System, XPS Nexus Foot Control, XPS Nexus IV Pole Medtronic Xomed, Inc. | ERL |
| Jul 22, 2015 | K151067 | Ventilation (Tympanostomy) Tubes Medtronic Xomed, Inc. | ETD |
| Nov 5, 2013 | K132297 | EM SINUS DILATION SYSTEM Medtronic Xomed, Inc. | LRC |
| Jan 10, 2013 | K122391 | MEDTRONIC XOMED, INC. Medtronic Xomed, Inc. | LRK |
| Oct 31, 2012 | K122434 | MEROGEL INJECTABLE BIORESORBABLE NASAL DRESSING AND SINUS STENT AND OTOLOGIC GEL Medtronic Xomed | NHB |
| Jun 27, 2012 | K112686 | NEXT GEN EMG ENDOTRACHEAL TUBE Medtronic Xomed, Inc. | ETN |
| Feb 10, 2012 | K110623 | PILLAR PALATAL IMPLANT SYSTEM Medtronic Xomed, Inc. | LRK |
| Jan 20, 2012 | K112662 | MICROFRANCE(R) WORMALD VASCULAR CLAMP Medtronic Xomed, Inc. | DXC |
| Oct 26, 2011 | K111520 | IPC POWEREASE SYSTEM Medtronic Xomed, Inc. | HBE |
| Feb 27, 2009 | K083124 | NIM 3.0 Medtronic Xomed, Inc. | GWF |
| Oct 17, 2008 | K081475 | ELECTRIC DRILL SYSTEM [XPS 4000 SYSTEM, MIDAS REX LEGEND EHS SYSTEM, INTEGRATED POWER CONSOLE (IPC)] Medtronic Xomed, Inc. | HBE |
| Sep 5, 2008 | K081277 | XPS 4000 SYSTEM, MIDAS REX LEGEND EHS SYSTEM, INTEGRATED POWER CONS0LE (IPC) Medtronic Xomed, Inc. | ERL |
| May 22, 2008 | K080257 | MICROFRANCE LAPAROSCOPIC MANUAL SURGICAL INSTRUMENTS Medtronic Xomed, Inc. | GCJ |
| Mar 24, 2008 | K073255 | XPS 3000 SYSTEM Medtronic Xomed, Inc. | ERL |
| Nov 29, 2006 | K063305 | STIMULATING BUR GUARD Medtronic Xomed, Inc. | ETN |
| Mar 3, 2006 | K053430 | TONO-PEN AVIA TONOMETER AND OCU-SHILED TIP COVER Medtronic Xomed, Inc. | HKY |
| Mar 3, 2005 | K050162 | CONTACT EMG ROTATABLE ENDOTRACHEAL TUBE Medtronic Xomed, Inc. | ETN |
| Sep 10, 2004 | K041381 | MEROPACK BIORESORBABLE NASAL PACKING AND SINUS STENT Medtronic Xomed, Inc. | LYA |
| Aug 12, 2004 | K041985 | XPS CURVED BUR Medtronic Xomed, Inc. | EQJ |
| Jul 23, 2004 | K041523 | XPS 3000 SYSTEM Medtronic Xomed, Inc. | ERL |
| Jul 12, 2004 | K041413 | XPS 3000 SYSTEM Medtronic Xomed, Inc. | ERL |
| Jun 18, 2003 | K031510 | NIM-SPINE Medtronic Xomed | ETN |
| Apr 11, 2003 | K031003 | STIMULUS/DISSECTION INSTRUMENTS, BALL-TIP PROBES Medtronic Xomed, Inc. | ETN |
| Jan 6, 2003 | K024316 | NIM-PRS Medtronic Xomed, Inc. | IKN |
| Oct 18, 2002 | K022370 | FRAMELOCK; FRAMELOCK ACCESSORIES Medtronic Xomed, Inc. | HBG |
| Jan 22, 2002 | K014165 | STIMULUS - DISSECTION INSTRUMENTS Medtronic Xomed, Inc. | ETN |
| Jun 26, 2001 | K011321 | MODIFICATION TO XPS 3000 SYSTEM Medtronic Xomed, Inc. | ERL |
| Jun 26, 2001 | K011191 | MEROCEL CORNELL LID AND LASH GUARD, MEROCEL AND KEROCEL OPHTHALMIC SPONGES Medtronic Xomed, Inc. | HOZ |
| May 7, 2001 | K010677 | XPS 3000 SYSTEM Medtronic Xomed, Inc. | HRX |
| May 7, 2001 | K010666 | XPS 3000 SYSTEM WITH RECIPROCATING ADAPTER AND SUCTION CANNULAE Medtronic Xomed, Inc. | QPB |
| Dec 15, 2000 | K002972 | MEROGEL CONTROL GEL ENT SURGICAL DRESSING Medtronic Xomed | KHJ |
| Dec 4, 2000 | K002224 | XPS 3000 SYSTEM Medtronic Xomed | ERL |
| Mar 21, 2000 | K000728 | MEDTRONIC SOLAN FIBEROPTIC CORNEAL LIGHT PROBE Medtronic Xomed | FST |
| Oct 22, 1999 | K990793 | ACCUGUIDE MUSCLE INJECTION MONITOR Medtronic Xomed | GXZ |
| Feb 11, 1997 | K963727 | HOFFMAN H/A COATED LONG-TERM VENTILATION TUBE WITH LINER Medtronic Xomed | ETD |
| Sep 23, 1996 | K963246 | TREBAY MICRODEBRIDER OR XPS STRAIGHT SHOT Medtronic Xomed | ERL |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 27, 2025 | Medtronic Xomed, Inc. IPC Powerease System REF 2300000
UDI-DI:
00613994448705
00643169406834.
The IPC POWEREASE System is indicated for drilling, tapping, and driving
screws and working end attachments during spinal surge Open, Classified |
HBE | K111520 |
| Apr 18, 2025 | Medtronic Xomed, Inc. NIM Vital Nerve Monitoring System:
CONSOLE NIM4CM01 NIM 4.0, REF: NIM4CM01;
CONSOLE NIM4CM01RF NIM 4.0 REFURBISHED, REF: NIM4CM01RF;
PATIENT INTERFACE NIM4CPB1 NIM 4.0, REF: NIM4CPB1;
PATIENT IN Open, Classified |
GWF | K200759 |
| Sep 12, 2024 | Medtronic Xomed, Inc. Medtronic ENT Ultra Round Steel Cutting Bur, Model Number REF 31313069 Open, Classified |
EQJ | None listed |
| Jul 24, 2024 | Medtronic Xomed, Inc. NIM Vital Nerve Monitoring systems (all serial numbers manufactured) with NIM Vital System versions: v1.0.0, v1.1.1, v1.3.2, v1.4.3.
NIM Vital Nerve Integrity Monitor with below product descriptions. Open, Classified |
GWF | K200759 |
| Jan 10, 2024 | Medtronic Xomed, Inc. NIM TriVantage EMG Endotracheal Tubes, Model (REF) Numbers and sizes:
a) 8229706, 6.0MM ID;
b) 8229707, 7.0MM ID;
c) 8229708, 8.0MM ID;
d) 8229736, 6MM ID 3PK;
e) 8229737, 7MM ID 3 PK;
f) 8229738 Open, Classified |
ETN | K112686 |
| Sep 1, 2022 | Medtronic Xomed, Inc. NIM EMG Endotracheal Tube, Part Numbers:
a) REF 8229307J
b) REF 8229308J
c) REF 8229306J Open, Classified |
ETN | None listed |
| Sep 1, 2022 | Medtronic Xomed, Inc. NIM EMG Endotracheal Tube, Part Numbers:
a) REF 8229308
b) REF 8229307
c) REF 8229306 Open, Classified |
ETN | K925640 |
| Sep 1, 2022 | Medtronic Xomed, Inc. NIM CONTACT EMG Endotracheal Tube, Part Numbers:
a) REF 8229508
b) REF 8229507
c) REF 8229506 Open, Classified |
ETN | K050162 |
| Jun 2, 2022 | Medtronic Xomed, Inc. NIM Vital Patient Interface 4.0 (P/N: NIM4CPB1) NIM with Software version 1.3.2 Open, Classified |
GWF | K200759 |
| Jun 2, 2022 | Medtronic Xomed, Inc. NIM Vital Console 4.0 (P/N: NIM4CM01) NIM with Software version 1.3.2 Open, Classified |
GWF | K200759 |
| Dec 22, 2021 | Medtronic Xomed, Inc. NIM TRIVANTAGE EMG Endotracheal Tube Open, Classified |
ETN | K112686 |
| Dec 15, 2021 | Medtronic Xomed, Inc. Software 1898072 IPC upgrade v 2.7.3.0, IPC System:
a) CONSOLE 1898001 IPC, Product Number 1898001; b) CONSOLE IPC REFURB, Product Number EC300RF; c) MASTER CONSOLE EC300 LEGEND EHS, Product Number EC Terminated |
ERL | K081277 K081475 |
| Oct 21, 2021 | Medtronic Xomed, Inc. Medtronic Sterile single-use blades that are components of the StraightShot M Series Handpiece and Fusion ENT Navigation Software, and the Midas Rex Microsaw and Triton System with the following produ Open, Classified |
HBE | K081475 |
| Oct 21, 2021 | Medtronic Xomed, Inc. Medtronic sterile single-use blades that are components of the StraightShot M Series Handpiece and Fusion ENT Navigation Software, and the Midas Rex Microsaw and Triton System with the following produ Open, Classified |
HAW | K130608 |
| Oct 21, 2021 | Medtronic Xomed, Inc. Medtronic sterile single-use blades that are components of the StraightShot M Series Handpiece and Fusion ENT Navigation Software, and the Midas Rex Microsaw and Triton System with the following produ Open, Classified |
EQJ | None listed |
| Jun 12, 2020 | Medtronic Xomed, Inc. Software 1898072 IPC upgrade v 2.7.3.0 - Product Usage: The IPC system is indicated for the incision/cutting removal, drilling and sawing of soft and hard tissue and bone in surgical procedures. Terminated |
ERL | None listed |
| Nov 13, 2019 | Medtronic Xomed, Inc. Lamicel 10PK 10MM INTL Open, Classified |
LOB | None listed |
| Nov 13, 2019 | Medtronic Xomed, Inc. Lamicel 20PK 5MM INTL Open, Classified |
LOB | None listed |
| Nov 13, 2019 | Medtronic Xomed, Inc. Lamicel 20PK 3MM INTL Cervical dilator Open, Classified |
LOB | None listed |
| Jun 28, 2016 | Medtronic Xomed, Inc. NIM EMG Endotracheal Tube, 6.0 mm I.D. x 8.8 mm O.D. (27 FR), Reinforced, Sterile, Rx only. Individually packaged. Terminated |
ETN | K925640 |
| Sep 26, 2013 | Medtronic Xomed, Inc. Universal Titanium Prosthesis, Round Head, with Flex H/A titanium shoe. The ear prosthesis is implantable and indicated for hearing loss. Terminated |
ETA | K002897 |
| Aug 9, 2013 | Medtronic Xomed, Inc. Tray Surgical, ENT (various instrument trays)
Used for stot age and transportation of reusable surgical instruments utilized in various ear, nose and throat (ENT) and head and neck surgical procedure Terminated |
MMO | None listed |
| Jun 4, 2013 | Medtronic Xomed, Inc. REF 8229705 x1 NIM TriVantage EMG Endotracheal Tube 5.0 mm I.D. x 6.5 mm O.D. Medtronic Xomed, Inc., 6743 Southpoint Drive North, Jacksonville, FL 32216-0980 USA STERILE Rx Only
The electrodes are Terminated |
ETN | K112686 |
| Sep 10, 2012 | Medtronic Xomed, Inc. Interfaces subject to recall:
Medtronic NIM (Nerve Integrity Monitor) 3.0 Patient Interfaces REF 8253210 (Pulse).
LABELING:
Box Label: REF 8253210 x1***NIM-Response 3.0 Patient Interface***Medtr Terminated |
GWF | K083124 |
| Sep 10, 2012 | Medtronic Xomed, Inc. Interfaces subject to recall:
Medtronic NIM (Nerve Integrity Monitor) 3.0 Patient Interfaces REF 8253410 (Neuro).
LABELING:
Box Label: REF 8253410 x1***NIM-Response 3.0 Patient Interface***Medtr Terminated |
GWF | K083124 |
| Sep 10, 2012 | Medtronic Xomed, Inc. Interfaces subject to recall:
Medtronic NIM (Nerve Integrity Monitor) 3.0 Patient Interfaces 8253200 (Response)
LABELING:
Box Label: REF 8253200 x1***NIM-Response 3.0 Patient Interface***Medtron Terminated |
GWF | K083124 |
| Mar 17, 2011 | Medtronic Xomed, Inc. Recall of Alcohol Pads contained in the following kits distributed by Medtronic:
***REF 1529100***Thermasplint Kit, Small***X5***.
***REF 1529110***Thermasplint Kit, Medium***X5***.
Terminated |
EPP | None listed |
| Mar 17, 2011 | Medtronic Xomed, Inc. An external nasal splint is a rigid or partially rigid device intended for the use externally for immobilization of part of the nose.
An external nasal splint is a rigid or partially rigid device in Terminated |
EPP | None listed |
| Dec 15, 2009 | Medtronic Xomed, Inc. Repose G2 Bone Screw, Sterile, REF 76310200, Lot # 62450200.
Distributed by Medtronic Xomed, Inc., Jacksonville, Florida 32216 U.S.A. Terminated |
LRK | K981677 |
| Dec 15, 2009 | Medtronic Xomed, Inc. Repose G2 Bone Screw System, Sterile, REF 76353200; Lot # 62450300.
Distributed by Medtronic Xomed, Inc. Jacksonville, Florida 32216 U.S.A.
The Repose G@ Bone Screw System is composed of the Repose Terminated |
LRK | K981677 |
| Nov 13, 2009 | Medtronic Xomed, Inc. Medtronic Integrated Power Console System, IP X1
REF 1898001 or REF EC300
Medtronic Xomed, Inc., 6743 Southpoint Drive North, Jacksonville, FL 32216-0980 USA.
Distributed by: Medtronic Powered Surg Terminated |
ERL | K002828 |
| Mar 3, 2009 | Medtronic Xomed, Inc. VARI-STIM III Nerve Locator/Stimulator, Sterile, Medtronic Xomed, Inc.
The Vari-Stim III nerve locator/stimulator is a sterile, single-use disposable, hand-held, battery-operated device intended to Terminated |
ETN | K031003 |
| Mar 7, 2007 | Medtronic Xomed, Inc. AccuGuide Injection Needles (Surface electrodes)
The AccuGuide EMG Injection Needle, product 8263210, contains 5 individually packaged and sterilized injection needles and 10 nonsterile surface ele Terminated |
GZX | K990793 |
| Dec 15, 2004 | Medtronic Xomed, Inc. Brand name:
NIM EMG Endotracheal Tube REF 82-29106, 82-29107, 82-29108
NIM EMG Reinforced Endotracheal Tube REF 82-29306, 82-29307, 82-29308
[ Terminated |
ETN | K925640 |
| Jul 20, 2004 | Medtronic Xomed, Inc. Product is a device used in adenoid surgery and is labeled as Lusk Disposable Adenoid Curettes. Terminated |
KBJ | None listed |
| Jul 20, 2004 | Medtronic Xomed, Inc. The product is a sheath meant to fit over a Nasopharyngoscope and is labeled as EndoScrub 2 Sheaths Terminated |
FED | K982594 |
| Jul 20, 2004 | Medtronic Xomed, Inc. Product is a surgical nasal/sinus surgical device labeled as a RAD Frontal Finesse Bur, Reference Number 18-83070 Terminated |
GFF | None listed |
| Mar 20, 2003 | Medtronic Xomed, Inc. Product is labeled as ''Oto-''Flex Bur'', Medtronic-Xomed brand, packed into a sterile pouch. Product is further packaged into a shelf box with similar labeling as follows:
Part Number 31-55631 Oto-Fl Terminated |
EQJ | None listed |