Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Atos Medical AB

FDA 510(k) & PMA Approved Devices — 14 products

Total Devices14
Categories0
Latest FDA decision
TypeNumberDevice NameCodeDateActions
510(k) K151404 ProTrach DualcareJOH2016-02-12 View
510(k) K131947 PROVOX VEGA PUNCTURE SETEWL2013-10-18 View
510(k) K092593 PROVOX ACTIVALVE (SIZE 4.5MM, 6MM, 8MM, 10MM, 12.5MM)EWL2010-10-14 View
510(k) K090455 PROVOX VEGA, MODEL 8130-8135EWL2009-06-05 View
510(k) K072582 PROVOX MICRON HMEJOH2008-05-30 View
510(k) K043138 PROVOX NID VOICE REHABILITATION SYSTEM, MODEL REF 7101 TO 7134EWL2004-11-22 View
510(k) K022125 PROVOX FREEHANDS HME, MODEL 7710EWL2002-07-30 View
510(k) K014102 PROVOX HME CASSETTE, MODEL 7240; PROVOX ADHESIVE, MODEL 7251JOH2002-02-21 View
510(k) K971244 PROVOX 2 VOICE PROSTHESIS SYSTEMEWL1997-06-06 View
510(k) K942495 SINOJET MAXILLARY SINUS PUNCTURE & IRRIGATION SYSTEMKAM1995-02-21 View
510(k) K940638 PROVOX(TM) VOICE PROSTHESISEWL1994-06-22 View
510(k) K936275 TYMPOVENTETD1994-05-05 View
510(k) K922145 SINOJECT MAXILLARY SINUS PUNCTURE & IRRIGATION SYSKAM1993-01-21 View
510(k) K896630 SINOVENT MAXILLARY SINUS DRAINAGE SYSTEMKAM1990-06-06 View
↑