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Medtronic Xomed, Inc. FDA Approvals

0 new drug approvals and 6 device clearances on file. Matched by name to MDT.

Newest first

A new drug approval is an original application; a 510(k) is a device shown equivalent to one already sold.

Product
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)510(k)Sep 4, 2026Neurology
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)510(k)Feb 10, 2026Ear, Nose, Throat
NIM Standard Reinforced EMG Endotracheal Tube; CONTACT Reinforced EMG Endotracheal Tube510(k)Oct 26, 2023Ear, Nose, Throat
NIM™ 35cm long Surgeon Control Probe, 1mm Ball-Tip (NIMDTP35)510(k)Aug 30, 2023Ear, Nose, Throat
NIM Surgeon Control Probe, Prass Tip, NIM Surgeon Control Probe, 1mm Ball Tip, NIM Surgeon Control Probe, 1mm Ball Tip, 35cm Long510(k)Mar 21, 2022Ear, Nose, Throat
NuVent Eustachian Tube Dilation Balloon510(k)Aug 16, 2021Ear, Nose, Throat

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