Medical Device Manufacturer · US , Jacksonville , FL

Medtronic Xomed, Inc. - FDA 510(k) Cleared Devices

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

FDA 510(k) cleared devices by Medtronic Xomed, Inc. Ear, Nose, Throat

22 devices
1-22 of 22
Cleared Feb 10, 2026
NIM Essence™ EMG Endotracheal Tube (NIMEID060)
K251672 · ETN
Ear, Nose, Throat · 256d
Cleared Oct 26, 2023
NIM Standard Reinforced EMG Endotracheal Tube
K230320 · ETN
Ear, Nose, Throat · 262d
Cleared Aug 30, 2023
NIM™ 35cm long Surgeon Control Probe, 1mm Ball-Tip (NIMDTP35)
K231580 · ETN
Ear, Nose, Throat · 91d
Cleared Mar 21, 2022
NIM Surgeon Control Probe, Prass Tip, NIM Surgeon Control Probe, 1mm Ball...
K213246 · ETN
Ear, Nose, Throat · 172d
Cleared Aug 16, 2021
NuVent Eustachian Tube Dilation Balloon
K210841 · PNZ
Ear, Nose, Throat · 147d
Cleared Apr 20, 2018
Sharpsite AC Rigid Endsocope
K173855 · EOB
Ear, Nose, Throat · 121d
Cleared Dec 01, 2015
NuVent EM Sinus Dilation System
K152121 · LRC
Ear, Nose, Throat · 124d
Cleared Aug 14, 2015
XPS Nexus System, XPS Nexus Foot Control, XPS Nexus IV Pole
K150728 · ERL
Ear, Nose, Throat · 147d
Cleared Jul 22, 2015
Ventilation (Tympanostomy) Tubes
K151067 · ETD
Ear, Nose, Throat · 92d
Cleared Nov 05, 2013
EM SINUS DILATION SYSTEM
K132297 · LRC
Ear, Nose, Throat · 104d
Cleared Jun 27, 2012
NEXT GEN EMG ENDOTRACHEAL TUBE
K112686 · ETN
Ear, Nose, Throat · 286d
Cleared Sep 05, 2008
XPS 4000 SYSTEM, MIDAS REX LEGEND EHS SYSTEM, INTEGRATED POWER CONS0LE (IPC)
K081277 · ERL
Ear, Nose, Throat · 123d
Cleared Mar 24, 2008
XPS 3000 SYSTEM
K073255 · ERL
Ear, Nose, Throat · 126d
Cleared Nov 29, 2006
STIMULATING BUR GUARD
K063305 · ETN
Ear, Nose, Throat · 28d
Cleared Mar 03, 2005
CONTACT EMG ROTATABLE ENDOTRACHEAL TUBE
K050162 · ETN
Ear, Nose, Throat · 37d
Cleared Sep 10, 2004
MEROPACK BIORESORBABLE NASAL PACKING AND SINUS STENT
K041381 · LYA
Ear, Nose, Throat · 108d
Cleared Aug 12, 2004
XPS CURVED BUR
K041985 · EQJ
Ear, Nose, Throat · 20d
Cleared Jul 23, 2004
XPS 3000 SYSTEM
K041523 · ERL
Ear, Nose, Throat · 45d
Cleared Jul 12, 2004
XPS 3000 SYSTEM
K041413 · ERL
Ear, Nose, Throat · 46d
Cleared Apr 11, 2003
STIMULUS/DISSECTION INSTRUMENTS, BALL-TIP PROBES
K031003 · ETN
Ear, Nose, Throat · 11d
Cleared Jan 22, 2002
STIMULUS - DISSECTION INSTRUMENTS
K014165 · ETN
Ear, Nose, Throat · 34d
Cleared Jun 26, 2001
MODIFICATION TO XPS 3000 SYSTEM
K011321 · ERL
Ear, Nose, Throat · 60d
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