Medtronic Xomed, Inc.
Medtronic Xomed, Inc. holds FDA 510(k) medical device clearances, first cleared 2001, most recent 2026, with 26 FDA device recalls on record.
Top product codes for Medtronic Xomed, Inc.
FDA recalls by Medtronic Xomed, Inc.
10 most recent of 26- Z-2461-2025 — 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 surgery, including open and minimally invasive procedures. The IPC POWEREASE System is also used in the placement of screws, or cutting of screws, posts, and rods. The IPC is indicated for the incision/cutting, removal, drilling, and sawing of soft and hard tissue and bone, and biomaterials in Neurosurgical (Cranial, Craniofacial), Orthopedic, Arthroscopic, Spinal, Sternotomy, and General surgical procedures.
- Z-1623-2025 — 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 INTFC NIM4CPB1RF NIM 4.0 REFURB, REF: NIM4CPB1RF; SOFTWARE NIM4SWU143 UPGRADE V1.4.3, REF: NIM4SWU143; SOFTWARE NIM4SWU154 UPGRADE V1.5.4, REF: NIM4SWU154; SOFTWARE NIM4SWU164 UPGRADE V1.6.4, REF: NIM4SWU164
- Z-3130-2024 — Medtronic ENT Ultra Round Steel Cutting Bur, Model Number REF 31313069
- Z-2409-2024 — 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. 1. CONSOLE NIM4CM01 NIM 4.0, Model Number: NIM4CM01. 2. CONSOLE NIM4CM01RF NIM 4.0 REFURBISHED, Model Number: NIM4CM01RF, 3. PATIENT INTERFACE NIM4CPB1 NIM 4.0, Model Number: NIM4CPB1, 4. PATIENT INTFC NIM4CPB1RF NIM 4.0 REFURB, Model Number: NIM4CPB1RF, 5. SOFTWARE NIM4SWU143 UPGRADE V1.4.3, Model Number: NIM4SWU143
- Z-0696-2024 — 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, 8MM ID 3 PK
- Z-1224-2022 — NIM Vital Patient Interface 4.0 (P/N: NIM4CPB1) NIM with Software version 1.3.2
- Z-1223-2022 — NIM Vital Console 4.0 (P/N: NIM4CM01) NIM with Software version 1.3.2
- Z-1520-2022 — NIM EMG Endotracheal Tube, Part Numbers: a) REF 8229308 b) REF 8229307 c) REF 8229306
- Z-1521-2022 — NIM EMG Endotracheal Tube, Part Numbers: a) REF 8229307J b) REF 8229308J c) REF 8229306J
- Z-1519-2022 — NIM CONTACT EMG Endotracheal Tube, Part Numbers: a) REF 8229508 b) REF 8229507 c) REF 8229506
Recalls are matched by FDA's recalling-firm name — openFDA's enforcement dataset doesn't reference 510(k) numbers, so a recall here may cover devices beyond this company's 510(k) clearances.
Recent clearances by Medtronic Xomed, Inc.
- K262235 — ApexCut Blade with Automated EM Tracking (6 models)
- K251672 — NIM Essence EMG Endotracheal Tube (5 models)
- K230320 — NIM Standard Reinforced EMG Endotracheal Tube; CONTACT Reinforced EMG Endotracheal Tube
- K231580 — NIM 35cm long Surgeon Control Probe, 1mm Ball-Tip (NIMDTP35)
- K213246 — NIM Surgeon Control Probe, Prass Tip, NIM Surgeon Control Probe, 1mm Ball Tip, NIM Surgeon Control Probe, 1mm Ball Tip, 35cm Long
- K210841 — NuVent Eustachian Tube Dilation Balloon
- K200759 — NIM Vital, Nerve Integrity Monitor
- K173855 — Sharpsite AC Rigid Endsocope
- K152121 — NuVent EM Sinus Dilation System
- K151758 — ALAR Nasal Valve Stent
- K150728 — XPS Nexus System, XPS Nexus Foot Control, XPS Nexus IV Pole
- K151067 — Ventilation (Tympanostomy) Tubes
- K132297 — EM SINUS DILATION SYSTEM
- K122391 — MEDTRONIC XOMED, INC.
- K112686 — NEXT GEN EMG ENDOTRACHEAL TUBE
- K110623 — PILLAR PALATAL IMPLANT SYSTEM
- K112662 — MICROFRANCE(R) WORMALD VASCULAR CLAMP
- K111520 — IPC POWEREASE SYSTEM
- K083124 — NIM 3.0
- K081475 — ELECTRIC DRILL SYSTEM [XPS 4000 SYSTEM, MIDAS REX LEGEND EHS SYSTEM, INTEGRATED POWER CONSOLE (IPC)]
- K081277 — XPS 4000 SYSTEM, MIDAS REX LEGEND EHS SYSTEM, INTEGRATED POWER CONS0LE (IPC)
- K080257 — MICROFRANCE LAPAROSCOPIC MANUAL SURGICAL INSTRUMENTS
- K073255 — XPS 3000 SYSTEM
- K063305 — STIMULATING BUR GUARD
- K053430 — TONO-PEN AVIA TONOMETER AND OCU-SHILED TIP COVER
- K050162 — CONTACT EMG ROTATABLE ENDOTRACHEAL TUBE
- K041381 — MEROPACK BIORESORBABLE NASAL PACKING AND SINUS STENT
- K041985 — XPS CURVED BUR
- K041523 — XPS 3000 SYSTEM
- K041413 — XPS 3000 SYSTEM
- K031003 — STIMULUS/DISSECTION INSTRUMENTS, BALL-TIP PROBES
- K024316 — NIM-PRS
- K022370 — FRAMELOCK; FRAMELOCK ACCESSORIES
- K014165 — STIMULUS - DISSECTION INSTRUMENTS
- K011191 — MEROCEL CORNELL LID AND LASH GUARD, MEROCEL AND KEROCEL OPHTHALMIC SPONGES
- K011321 — MODIFICATION TO XPS 3000 SYSTEM
- K010666 — XPS 3000 SYSTEM WITH RECIPROCATING ADAPTER AND SUCTION CANNULAE
- K010677 — XPS 3000 SYSTEM
Data sourced from openFDA. This site is unofficial and independent of the FDA.