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.

15 devices
1–12 of 15
ProTrach Dualcare
K151404 · JOH Tube Tracheostomy And Tube Cuff · Anesthesiology
Feb 2016 262d
PROVOX FREEHANDS FLEXIVOICE
K141380 · EWL Prosthesis, Laryngeal (taub) · Ear, Nose, Throat
Sep 2014 122d
PROVOX VEGA PUNCTURE SET
K131947 · EWL Prosthesis, Laryngeal (taub) · Ear, Nose, Throat
Oct 2013 113d
PROVOX ACTIVALVE (SIZE 4.5MM, 6MM, 8MM, 10MM, 12.5MM)
K092593 · EWL Prosthesis, Laryngeal (taub) · Ear, Nose, Throat
Oct 2010 416d
PROVOX VEGA, MODEL 8130-8135
K090455 · EWL Prosthesis, Laryngeal (taub) · Ear, Nose, Throat
Jun 2009 102d
PROVOX MICRON HME
K072582 · JOH Tube Tracheostomy And Tube Cuff · Anesthesiology
May 2008 260d
PROVOX NID VOICE REHABILITATION SYSTEM, MODEL REF 7101 TO 7134
K043138 · EWL Prosthesis, Laryngeal (taub) · Ear, Nose, Throat
Nov 2004 10d
PROVOX FREEHANDS HME, MODEL 7710
K022125 · EWL Prosthesis, Laryngeal (taub) · Ear, Nose, Throat
Jul 2002 29d
PROVOX HME CASSETTE, MODEL 7240; PROVOX ADHESIVE, MODEL 7251
K014102 · JOH Tube Tracheostomy And Tube Cuff · Anesthesiology
Feb 2002 70d
PROVOX 2 VOICE PROSTHESIS SYSTEM
K971244 · EWL Prosthesis, Laryngeal (taub) · Ear, Nose, Throat
Jun 1997 64d
SINOJET MAXILLARY SINUS PUNCTURE & IRRIGATION SYSTEM
K942495 · KAM Cannula, Sinus · General & Plastic Surgery
Feb 1995 280d
PROVOX(TM) VOICE PROSTHESIS
K940638 · EWL Prosthesis, Laryngeal (taub) · Ear, Nose, Throat
Jun 1994 128d
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All15 Ear, Nose, Throat 9 General & Plastic Surgery 3 Anesthesiology 3