Medical Device Manufacturer · US , Jacksonville , FL

Medtronic Xomed, Inc.

37 submissions · 37 cleared · Since 2001
37
Total
37
Cleared
0
Denied

Medtronic Xomed, Inc. — FDA 510(k) Submissions

Medtronic Xomed, Inc. has submitted 37 FDA 510(k) premarket notifications since 2001, of which 37 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Stimulator, Nerve, Drill, Surgical, Ent (electric Or Pneumatic) Including Handpiece, Instrument, Ent Manual Surgical, Drills, Burrs, Trephines & Accessories (simple, Powered), Stimulator, Electrical, Evoked Response . Use the specialty filter in the sidebar to narrow results.

37 devices
1–25 of 37
NIM Essence? EMG Endotracheal Tube (NIMEID060); NIM Essence? EMG Endotracheal Tube (NIMEID065); NIM Essence? EMG Endotracheal Tube (NIMEID070); NIM Essence? EMG Endotracheal Tube (NIMEID075); NIM Essence? EMG Endotracheal Tube (NIMEID080)
K251672 · ETN Stimulator, Nerve · Ear, Nose, Throat
Feb 2026 256d
NIM Standard Reinforced EMG Endotracheal Tube; CONTACT Reinforced EMG Endotracheal Tube
K230320 · ETN Stimulator, Nerve · Ear, Nose, Throat
Oct 2023 262d
NIM? 35cm long Surgeon Control Probe, 1mm Ball-Tip (NIMDTP35)
K231580 · ETN Stimulator, Nerve · Ear, Nose, Throat
Aug 2023 91d
NIM Surgeon Control Probe, Prass Tip, NIM Surgeon Control Probe, 1mm Ball Tip, NIM Surgeon Control Probe, 1mm Ball Tip, 35cm Long
K213246 · ETN Stimulator, Nerve · Ear, Nose, Throat
Mar 2022 172d
NuVent Eustachian Tube Dilation Balloon
K210841 · PNZ Eustachian Tube Balloon... · Ear, Nose, Throat
Aug 2021 147d
NIM Vital, Nerve Integrity Monitor
K200759 · GWF Stimulator, Electrical,... · Neurology
Oct 2020 218d
Sharpsite AC Rigid Endsocope
K173855 · EOB Nasopharyngoscope... · Ear, Nose, Throat
Apr 2018 121d
NuVent EM Sinus Dilation System
K152121 · LRC Instrument, Ent Manual... · Ear, Nose, Throat
Dec 2015 124d
ALAR Nasal Valve Stent
K151758 · GAT Suture, Nonabsorbable,... · General & Plastic Surgery
Oct 2015 122d
XPS Nexus System, XPS Nexus Foot Control, XPS Nexus IV Pole
K150728 · ERL Drill, Surgical, Ent... · Ear, Nose, Throat
Aug 2015 147d
Ventilation (Tympanostomy) Tubes
K151067 · ETD Tube, Tympanostomy · Ear, Nose, Throat
Jul 2015 92d
EM SINUS DILATION SYSTEM
K132297 · LRC Instrument, Ent Manual... · Ear, Nose, Throat
Nov 2013 104d
MEDTRONIC XOMED, INC.
K122391 · LRK Device, Anti-snoring · Dental
Jan 2013 156d
NEXT GEN EMG ENDOTRACHEAL TUBE
K112686 · ETN Stimulator, Nerve · Ear, Nose, Throat
Jun 2012 286d
PILLAR PALATAL IMPLANT SYSTEM
K110623 · LRK Device, Anti-snoring · Dental
Feb 2012 344d
MICROFRANCE(R) WORMALD VASCULAR CLAMP
K112662 · DXC Clamp, Vascular · Cardiovascular
Jan 2012 129d
IPC POWEREASE SYSTEM
K111520 · HBE Drills, Burrs, Trephines... · Neurology
Oct 2011 146d
NIM 3.0
K083124 · GWF Stimulator, Electrical,... · Neurology
Feb 2009 128d
ELECTRIC DRILL SYSTEM [XPS 4000 SYSTEM, MIDAS REX LEGEND EHS SYSTEM, INTEGRATED POWER CONSOLE (IPC)]
K081475 · HBE Drills, Burrs, Trephines... · Neurology
Oct 2008 143d
XPS 4000 SYSTEM, MIDAS REX LEGEND EHS SYSTEM, INTEGRATED POWER CONS0LE (IPC)
K081277 · ERL Drill, Surgical, Ent... · Ear, Nose, Throat
Sep 2008 123d
MICROFRANCE LAPAROSCOPIC MANUAL SURGICAL INSTRUMENTS
K080257 · GCJ Laparoscope, General &... · General & Plastic Surgery
May 2008 112d
XPS 3000 SYSTEM
K073255 · ERL Drill, Surgical, Ent... · Ear, Nose, Throat
Mar 2008 126d
STIMULATING BUR GUARD
K063305 · ETN Stimulator, Nerve · Ear, Nose, Throat
Nov 2006 28d
TONO-PEN AVIA TONOMETER AND OCU-SHILED TIP COVER
K053430 · HKY Tonometer, Manual · Ophthalmic
Mar 2006 84d
CONTACT EMG ROTATABLE ENDOTRACHEAL TUBE
K050162 · ETN Stimulator, Nerve · Ear, Nose, Throat
Mar 2005 37d
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