Atos Medical AB

FDA Regulatory Profile

Summary

Total Recalls
1
510(k) Clearances
15
Inspections
4
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-1548-2021Class IIProvox Life Night HME, Catalogue Number 8262 - Product Usage: single use heat and moisture exchangeMarch 29, 2021

Recent 510(k) Clearances

K-NumberDeviceDate
K151404ProTrach DualcareFebruary 12, 2016
K141380PROVOX FREEHANDS FLEXIVOICESeptember 26, 2014
K131947PROVOX VEGA PUNCTURE SETOctober 18, 2013
K092593PROVOX ACTIVALVE (SIZE 4.5MM, 6MM, 8MM, 10MM, 12.5MM)October 14, 2010
K090455PROVOX VEGA, MODEL 8130-8135June 5, 2009
K072582PROVOX MICRON HMEMay 30, 2008
K043138PROVOX NID VOICE REHABILITATION SYSTEM, MODEL REF 7101 TO 7134November 22, 2004
K022125PROVOX FREEHANDS HME, MODEL 7710July 30, 2002
K014102PROVOX HME CASSETTE, MODEL 7240; PROVOX ADHESIVE, MODEL 7251February 21, 2002
K971244PROVOX 2 VOICE PROSTHESIS SYSTEMJune 6, 1997
K942495SINOJET MAXILLARY SINUS PUNCTURE & IRRIGATION SYSTEMFebruary 21, 1995
K940638PROVOX(TM) VOICE PROSTHESISJune 22, 1994
K936275TYMPOVENTMay 5, 1994
K922145SINOJECT MAXILLARY SINUS PUNCTURE & IRRIGATION SYSJanuary 21, 1993
K896630SINOVENT MAXILLARY SINUS DRAINAGE SYSTEMJune 6, 1990