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Medtronic Xomed, Inc.

FDA 510(k) & PMA Approved Devices — 34 products

Total Devices34
Categories0
Latest FDA decision
TypeNumberDevice NameCodeDateActions
510(k) K262235 ApexCut ™ Blade with Automated EM Tracking (187BL4012EM);ApexCut ™ Blade with Automated EM Tracking (187BL4040EM);ApexCut ™ Blade with Automated EM Tracking (187BL4060EM);ApexCut ™ Blade with Automated EM Tracking (187BL2975EM);ApexCut ™ Blade with Automated EM Tracking (187BL3590EM);ApexCut ™ Blade with Automated EM Tracking (187BL4000LEM)PGW2026-09-04 View
510(k) K251672 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)ETN2026-02-10 View
510(k) K230320 NIM Standard Reinforced EMG Endotracheal Tube; CONTACT Reinforced EMG Endotracheal TubeETN2023-10-26 View
510(k) K231580 NIM™ 35cm long Surgeon Control Probe, 1mm Ball-Tip (NIMDTP35)ETN2023-08-30 View
510(k) K213246 NIM Surgeon Control Probe, Prass Tip, NIM Surgeon Control Probe, 1mm Ball Tip, NIM Surgeon Control Probe, 1mm Ball Tip, 35cm LongETN2022-03-21 View
510(k) K210841 NuVent Eustachian Tube Dilation BalloonPNZ2021-08-16 View
510(k) K200759 NIM Vital, Nerve Integrity MonitorGWF2020-10-28 View
510(k) K173855 Sharpsite AC Rigid EndsocopeEOB2018-04-20 View
510(k) K132297 EM SINUS DILATION SYSTEMLRC2013-11-05 View
510(k) K122391 MEDTRONIC XOMED, INC.LRK2013-01-10 View
510(k) K112686 NEXT GEN EMG ENDOTRACHEAL TUBEETN2012-06-27 View
510(k) K110623 PILLAR PALATAL IMPLANT SYSTEMLRK2012-02-10 View
510(k) K112662 MICROFRANCE(R) WORMALD VASCULAR CLAMPDXC2012-01-20 View
510(k) K111520 IPC POWEREASE SYSTEMHBE2011-10-26 View
510(k) K083124 NIM 3.0GWF2009-02-27 View
510(k) K081475 ELECTRIC DRILL SYSTEM [XPS 4000 SYSTEM, MIDAS REX LEGEND EHS SYSTEM, INTEGRATED POWER CONSOLE (IPC)]HBE2008-10-17 View
510(k) K081277 XPS 4000 SYSTEM, MIDAS REX LEGEND EHS SYSTEM, INTEGRATED POWER CONS0LE (IPC)ERL2008-09-05 View
510(k) K080257 MICROFRANCE LAPAROSCOPIC MANUAL SURGICAL INSTRUMENTSGCJ2008-05-22 View
510(k) K073255 XPS 3000 SYSTEMERL2008-03-24 View
510(k) K063305 STIMULATING BUR GUARDETN2006-11-29 View
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