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Medtronic Xomed, Inc.

37 FDA 510(k) clearances · Manufacturer

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RecordFirmDate
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)Medtronic Xomed, Inc.2026-02-10
NIM Standard Reinforced EMG Endotracheal Tube; CONTACT Reinforced EMG Endotracheal Tube (K230320)Medtronic Xomed, Inc.2023-10-26
NIM™ 35cm long Surgeon Control Probe, 1mm Ball-Tip (NIMDTP35) (K231580)Medtronic Xomed, Inc.2023-08-30
NIM Surgeon Control Probe, Prass Tip, NIM Surgeon Control Probe, 1mm Ball Tip, NIM Surgeon Control Probe, 1mm Ball Tip, 35cm Long (K213246)Medtronic Xomed, Inc.2022-03-21
NuVent Eustachian Tube Dilation Balloon (K210841)Medtronic Xomed, Inc.2021-08-16
NIM Vital, Nerve Integrity Monitor (K200759)Medtronic Xomed, Inc.2020-10-28
Sharpsite AC Rigid Endsocope (K173855)Medtronic Xomed, Inc.2018-04-20
NuVent EM Sinus Dilation System (K152121)Medtronic Xomed, Inc.2015-12-01
ALAR Nasal Valve Stent (K151758)Medtronic Xomed, Inc.2015-10-29
XPS Nexus System, XPS Nexus Foot Control, XPS Nexus IV Pole (K150728)Medtronic Xomed, Inc.2015-08-14
Ventilation (Tympanostomy) Tubes (K151067)Medtronic Xomed, Inc.2015-07-22
EM SINUS DILATION SYSTEM (K132297)Medtronic Xomed, Inc.2013-11-05
MEDTRONIC XOMED, INC. (K122391)Medtronic Xomed, Inc.2013-01-10
NEXT GEN EMG ENDOTRACHEAL TUBE (K112686)Medtronic Xomed, Inc.2012-06-27
PILLAR PALATAL IMPLANT SYSTEM (K110623)Medtronic Xomed, Inc.2012-02-10
MICROFRANCE(R) WORMALD VASCULAR CLAMP (K112662)Medtronic Xomed, Inc.2012-01-20
IPC POWEREASE SYSTEM (K111520)Medtronic Xomed, Inc.2011-10-26
NIM 3.0 (K083124)Medtronic Xomed, Inc.2009-02-27
ELECTRIC DRILL SYSTEM [XPS 4000 SYSTEM, MIDAS REX LEGEND EHS SYSTEM, INTEGRATED POWER CONSOLE (IPC)] (K081475)Medtronic Xomed, Inc.2008-10-17
XPS 4000 SYSTEM, MIDAS REX LEGEND EHS SYSTEM, INTEGRATED POWER CONS0LE (IPC) (K081277)Medtronic Xomed, Inc.2008-09-05
MICROFRANCE LAPAROSCOPIC MANUAL SURGICAL INSTRUMENTS (K080257)Medtronic Xomed, Inc.2008-05-22
XPS 3000 SYSTEM (K073255)Medtronic Xomed, Inc.2008-03-24
STIMULATING BUR GUARD (K063305)Medtronic Xomed, Inc.2006-11-29
TONO-PEN AVIA TONOMETER AND OCU-SHILED TIP COVER (K053430)Medtronic Xomed, Inc.2006-03-03
CONTACT EMG ROTATABLE ENDOTRACHEAL TUBE (K050162)Medtronic Xomed, Inc.2005-03-03
MEROPACK BIORESORBABLE NASAL PACKING AND SINUS STENT (K041381)Medtronic Xomed, Inc.2004-09-10
XPS CURVED BUR (K041985)Medtronic Xomed, Inc.2004-08-12
XPS 3000 SYSTEM (K041523)Medtronic Xomed, Inc.2004-07-23
XPS 3000 SYSTEM (K041413)Medtronic Xomed, Inc.2004-07-12
STIMULUS/DISSECTION INSTRUMENTS, BALL-TIP PROBES (K031003)Medtronic Xomed, Inc.2003-04-11
NIM-PRS (K024316)Medtronic Xomed, Inc.2003-01-06
FRAMELOCK; FRAMELOCK ACCESSORIES (K022370)Medtronic Xomed, Inc.2002-10-18
STIMULUS - DISSECTION INSTRUMENTS (K014165)Medtronic Xomed, Inc.2002-01-22
MODIFICATION TO XPS 3000 SYSTEM (K011321)Medtronic Xomed, Inc.2001-06-26
MEROCEL CORNELL LID AND LASH GUARD, MEROCEL AND KEROCEL OPHTHALMIC SPONGES (K011191)Medtronic Xomed, Inc.2001-06-26
XPS 3000 SYSTEM (K010677)Medtronic Xomed, Inc.2001-05-07
XPS 3000 SYSTEM WITH RECIPROCATING ADAPTER AND SUCTION CANNULAE (K010666)Medtronic Xomed, Inc.2001-05-07

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Every clearance here is in the API, with alerts when new ones post.