Medical Device Manufacturer · US , Potomac , MD

Atos Medical AB - FDA 510(k) Cleared Devices

15 submissions · 14 cleared · Since 1990
15
Total
14
Cleared
0
Denied

Atos Medical AB has 14 FDA 510(k) cleared medical devices. Based in Potomac, US.

Historical record: 14 cleared submissions from 1990 to 2016. Primary specialty: Ear, Nose, Throat.

Browse the FDA 510(k) cleared devices submitted by Atos Medical AB Filter by specialty or product code using the sidebar.

FDA 510(k) Regulatory Record - Atos Medical AB
15 devices
1-12 of 15
Cleared Feb 12, 2016
ProTrach Dualcare
K151404 · JOH
Anesthesiology · 262d
Cleared Sep 26, 2014
PROVOX FREEHANDS FLEXIVOICE
K141380 · EWL
Ear, Nose, Throat · 122d
Cleared Oct 18, 2013
PROVOX VEGA PUNCTURE SET
K131947 · EWL
Ear, Nose, Throat · 113d
Cleared Oct 14, 2010
PROVOX ACTIVALVE (SIZE 4.5MM, 6MM, 8MM, 10MM, 12.5MM)
K092593 · EWL
Ear, Nose, Throat · 416d
Cleared Jun 05, 2009
PROVOX VEGA, MODEL 8130-8135
K090455 · EWL
Ear, Nose, Throat · 102d
Cleared May 30, 2008
PROVOX MICRON HME
K072582 · JOH
Anesthesiology · 260d
Cleared Nov 22, 2004
PROVOX NID VOICE REHABILITATION SYSTEM, MODEL REF 7101 TO 7134
K043138 · EWL
Ear, Nose, Throat · 10d
Cleared Jul 30, 2002
PROVOX FREEHANDS HME, MODEL 7710
K022125 · EWL
Ear, Nose, Throat · 29d
Cleared Feb 21, 2002
PROVOX HME CASSETTE, MODEL 7240
K014102 · JOH
Anesthesiology · 70d
Cleared Jun 06, 1997
PROVOX 2 VOICE PROSTHESIS SYSTEM
K971244 · EWL
Ear, Nose, Throat · 64d
Cleared Feb 21, 1995
SINOJET MAXILLARY SINUS PUNCTURE & IRRIGATION SYSTEM
K942495 · KAM
General & Plastic Surgery · 280d
Cleared Jun 22, 1994
PROVOX(TM) VOICE PROSTHESIS
K940638 · EWL
Ear, Nose, Throat · 128d
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All15 Ear, Nose, Throat 9 General & Plastic Surgery 3 Anesthesiology 3