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, NIM-SPINE

View 9 510(k) Devices ↓

Total

Cleared

Denied

Medtronic Xomed has 9 FDA 510(k) cleared medical devices. Based in Jacksonville, US.

Historical record: 9 cleared submissions from 1996 to 2020. Primary specialty: Ear, Nose, Throat.

Browse the FDA 510(k) cleared devices submitted by Medtronic Xomed Filter by specialty or product code using the sidebar.

510(k) submissions have been managed by Citech as regulatory consultant.

Medtronic Xomed is one of 25969 FDA 510(k) medical device manufacturers from United States in the dataset, ranked by real submission volume.

FDA 510(k) Regulatory Record - Medtronic Xomed

9 devices

1-9 of 9

Cleared Dec 08, 2020

Novapak Nasal Sinus Packing and Stent

K202623 · LYA

Ear, Nose, Throat · 89d

Cleared Oct 31, 2012

MEROGEL INJECTABLE BIORESORBABLE NASAL DRESSING AND SINUS STENT AND OTOLOGIC GEL

K122434 · NHB

Ear, Nose, Throat · 82d

Cleared Jun 18, 2003

NIM-SPINE

K031510 · ETN

Ear, Nose, Throat · 35d

Cleared Dec 15, 2000

MEROGEL CONTROL GEL ENT SURGICAL DRESSING

K002972 · KHJ

Ear, Nose, Throat · 84d

Cleared Dec 04, 2000

XPS 3000 SYSTEM

K002224 · ERL

Ear, Nose, Throat · 133d

Cleared Mar 21, 2000

MEDTRONIC SOLAN FIBEROPTIC CORNEAL LIGHT PROBE

K000728 · FST

General & Plastic Surgery · 15d

Cleared Oct 22, 1999

ACCUGUIDE MUSCLE INJECTION MONITOR

K990793 · GXZ

Neurology · 226d

Cleared Feb 11, 1997

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

K963727 · ETD

Ear, Nose, Throat · 148d

Cleared Sep 23, 1996

TREBAY MICRODEBRIDER OR XPS STRAIGHT SHOT

K963246 · ERL

Ear, Nose, Throat · 35d

Medtronic Xomed - FDA 510(k) Cleared Devices

FDA 510(k) Regulatory Record - Medtronic Xomed

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