Company ยท SE
Atos Medical AB
FDA 510(k) clearances and medical device recalls filed under this name, 1990 to 2016. Name variants (Inc, Corp, punctuation) are merged.
15510(k) clearances (0 in 12 months)
1recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Feb 12, 2016 | K151404 | ProTrach Dualcare Atos Medical AB, SE | JOH |
| Sep 26, 2014 | K141380 | PROVOX FREEHANDS FLEXIVOICE Atos Medical AB, SE | EWL |
| Oct 18, 2013 | K131947 | PROVOX VEGA PUNCTURE SET Atos Medical AB, SE | EWL |
| Oct 14, 2010 | K092593 | PROVOX ACTIVALVE (SIZE 4.5MM, 6MM, 8MM, 10MM, 12.5MM) Atos Medical AB, SE | EWL |
| Jun 5, 2009 | K090455 | PROVOX VEGA, MODEL 8130-8135 Atos Medical AB, SE | EWL |
| May 30, 2008 | K072582 | PROVOX MICRON HME Atos Medical AB | JOH |
| Nov 22, 2004 | K043138 | PROVOX NID VOICE REHABILITATION SYSTEM, MODEL REF 7101 TO 7134 Atos Medical AB, SE | EWL |
| Jul 30, 2002 | K022125 | PROVOX FREEHANDS HME, MODEL 7710 Atos Medical AB, SE | EWL |
| Feb 21, 2002 | K014102 | PROVOX HME CASSETTE, MODEL 7240; PROVOX ADHESIVE, MODEL 7251 Atos Medical AB, SE | JOH |
| Jun 6, 1997 | K971244 | PROVOX 2 VOICE PROSTHESIS SYSTEM Atos Medical AB, SE | EWL |
| Feb 21, 1995 | K942495 | SINOJET MAXILLARY SINUS PUNCTURE & IRRIGATION SYSTEM Atos Medical AB, SE | KAM |
| Jun 22, 1994 | K940638 | PROVOX(TM) VOICE PROSTHESIS Atos Medical AB, SE | EWL |
| May 5, 1994 | K936275 | TYMPOVENT Atos Medical AB, SE | ETD |
| Jan 21, 1993 | K922145 | SINOJECT MAXILLARY SINUS PUNCTURE & IRRIGATION SYS Atos Medical AB | KAM |
| Jun 6, 1990 | K896630 | SINOVENT MAXILLARY SINUS DRAINAGE SYSTEM Atos Medical AB | KAM |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 29, 2021 | Atos Medical AB Provox Life Night HME, Catalogue Number 8262 - Product Usage: single use heat and moisture exchangers for patients breathing through a tracheostoma. Terminated |
BYD | None listed |