Medical device makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field. in SwedenLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field., part of ColoplastLabelled by claude-sonnet-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under 2 spellings of its name, each linked to the record.
As of Nov 15, 2026, FDA's public records list Atos Medical with 15 510(k) clearances and 1 device recall. The most recent is a device recall dated Mar 29, 2021: Provox Life Night HME, Catalogue Number 8262 - Product Usage: single use heat and moist….
Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date
A hatched bar is a year that is not over, so its count covers only part of the year.
| Mar 29, 2021 | Provox Life Night HME, Catalogue Number 8262 - Product Usage: single use heat and moisture exchangers for patients breathing through a tracClass II · Provox Life Night HME may be incorrectly inserted sideways or forcefully through the adhesive coupling potentially occlu | Device recalls |
| Feb 12, 2016 | ProTrach DualcareK151404 · JOH | 510(k) clearances |
| Sep 26, 2014 | PROVOX FREEHANDS FLEXIVOICEK141380 · EWL | 510(k) clearances |
| Oct 18, 2013 | PROVOX VEGA PUNCTURE SETK131947 · EWL | 510(k) clearances |
| Oct 14, 2010 | PROVOX ACTIVALVE (SIZE 4.5MM, 6MM, 8MM, 10MM, 12.5MM)K092593 · EWL | 510(k) clearances |
| Jun 5, 2009 | PROVOX VEGA, MODEL 8130-8135K090455 · EWL | 510(k) clearances |
| May 30, 2008 | PROVOX MICRON HMEK072582 · JOH | 510(k) clearances |
| Nov 22, 2004 | PROVOX NID VOICE REHABILITATION SYSTEM, MODEL REF 7101 TO 7134K043138 · EWL | 510(k) clearances |
| Jul 30, 2002 | PROVOX FREEHANDS HME, MODEL 7710K022125 · EWL | 510(k) clearances |
Spellings are joined only when they reduce to the same name, or a reviewed source names the same company. Sharing an FDA establishment number (FEI) is not enough: contract sites make products for many firms. Facts marked AI were labelled by a language model from the firm's FDA names; everything else comes from FDA or Wikidata. How this page is built
