Medical Device Manufacturer · US , Jacksonville , FL

Medtronic Xomed - FDA 510(k) Cleared Devices

9 submissions · 9 cleared · Since 1996

Recent clearances: Novapak Nasal Sinus Packing and Stent, MEROGEL INJECTABLE BIORESORBABLE NASAL DRESSING AND SINUS STENT AND OTOLOGIC GEL, ACCUGUIDE MUSCLE INJECTION MONITOR

9

Total

9

Cleared

0

Denied

FDA 510(k) Regulatory Record - Medtronic Xomed Ear, Nose, Throat ✕

7 devices

1-7 of 7

Cleared Dec 08, 2020

Novapak Nasal Sinus Packing and Stent

Ear, Nose, Throat · 89d

Cleared Oct 31, 2012

MEROGEL INJECTABLE BIORESORBABLE NASAL DRESSING AND SINUS STENT AND OTOLOGIC GEL

Ear, Nose, Throat · 82d

Cleared Jun 18, 2003

Ear, Nose, Throat · 35d

Cleared Dec 15, 2000

MEROGEL CONTROL GEL ENT SURGICAL DRESSING

Ear, Nose, Throat · 84d

Cleared Dec 04, 2000

XPS 3000 SYSTEM

Ear, Nose, Throat · 133d

Cleared Feb 11, 1997

HOFFMAN H/A COATED LONG-TERM VENTILATION TUBE WITH LINER

Ear, Nose, Throat · 148d

Cleared Sep 23, 1996

TREBAY MICRODEBRIDER OR XPS STRAIGHT SHOT

Ear, Nose, Throat · 35d