Atos Medical AB
FDA Regulatory Profile
Atos Medical AB appears in FDA public data with 1 recall, 15 510(k) clearances, 4 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-1548-2021, Class II) was initiated on March 29, 2021. Its most recent 510(k) clearance was granted on February 12, 2016.
Summary
- Total Recalls
- 1
- 510(k) Clearances
- 15
- Inspections
- 4
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-1548-2021 | Class II | Provox Life Night HME, Catalogue Number 8262 - Product Usage: single use heat and moisture exchange | March 29, 2021 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K151404 | ProTrach Dualcare | February 12, 2016 |
| K141380 | PROVOX FREEHANDS FLEXIVOICE | September 26, 2014 |
| K131947 | PROVOX VEGA PUNCTURE SET | October 18, 2013 |
| K092593 | PROVOX ACTIVALVE (SIZE 4.5MM, 6MM, 8MM, 10MM, 12.5MM) | October 14, 2010 |
| K090455 | PROVOX VEGA, MODEL 8130-8135 | June 5, 2009 |
| K072582 | PROVOX MICRON HME | May 30, 2008 |
| K043138 | PROVOX NID VOICE REHABILITATION SYSTEM, MODEL REF 7101 TO 7134 | November 22, 2004 |
| K022125 | PROVOX FREEHANDS HME, MODEL 7710 | July 30, 2002 |
| K014102 | PROVOX HME CASSETTE, MODEL 7240; PROVOX ADHESIVE, MODEL 7251 | February 21, 2002 |
| K971244 | PROVOX 2 VOICE PROSTHESIS SYSTEM | June 6, 1997 |
| K942495 | SINOJET MAXILLARY SINUS PUNCTURE & IRRIGATION SYSTEM | February 21, 1995 |
| K940638 | PROVOX(TM) VOICE PROSTHESIS | June 22, 1994 |
| K936275 | TYMPOVENT | May 5, 1994 |
| K922145 | SINOJECT MAXILLARY SINUS PUNCTURE & IRRIGATION SYS | January 21, 1993 |
| K896630 | SINOVENT MAXILLARY SINUS DRAINAGE SYSTEM | June 6, 1990 |