Medical Device Manufacturer · US , Potomac , MD

Atos Medical AB - FDA 510(k) Cleared Devices

15 submissions · 14 cleared · Since 1990

Recent clearances: ProTrach Dualcare, PROVOX FREEHANDS FLEXIVOICE, PROVOX VEGA PUNCTURE SET

View 15 510(k) Devices ↓

15

Total

14

Cleared

0

Denied

FDA 510(k) Regulatory Record - Atos Medical AB Ear, Nose, Throat ✕

9 devices

1-9 of 9

Cleared Sep 26, 2014

PROVOX FREEHANDS FLEXIVOICE

Ear, Nose, Throat · 122d

Cleared Oct 18, 2013

PROVOX VEGA PUNCTURE SET

Ear, Nose, Throat · 113d

Cleared Oct 14, 2010

PROVOX ACTIVALVE (SIZE 4.5MM, 6MM, 8MM, 10MM, 12.5MM)

Ear, Nose, Throat · 416d

Cleared CT Jun 05, 2009

PROVOX VEGA, MODEL 8130-8135

Ear, Nose, Throat · 102d

Cleared Nov 22, 2004

PROVOX NID VOICE REHABILITATION SYSTEM, MODEL REF 7101 TO 7134

Ear, Nose, Throat · 10d

Cleared Jul 30, 2002

PROVOX FREEHANDS HME, MODEL 7710

Ear, Nose, Throat · 29d

Cleared Jun 06, 1997

PROVOX 2 VOICE PROSTHESIS SYSTEM

Ear, Nose, Throat · 64d

Cleared Jun 22, 1994

PROVOX(TM) VOICE PROSTHESIS

Ear, Nose, Throat · 128d

Cleared May 05, 1994

Ear, Nose, Throat · 126d