# Atos Medical AB

- Location (FDA's records): Horby, SE
- FDA decisions: 15 (1990–2016): 15 510(k) clearances
- Product codes: EWL (8), JOH (3), KAM (3), ETD (1)
- Predicates its devices cite: 14 (8 its own); citations of its devices by later devices: 10 (8 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Bivona Medical Technologies: 3 (https://510kreport.com/company/bivona-medical-technologies)
- Fogless International AB: 1 (https://510kreport.com/company/fogless-international)
- Helix Medical, Inc.: 1 (https://510kreport.com/company/helix-medical)
- Datex-Ohmeda, Inc.: 1 (https://510kreport.com/company/datex-ohmeda)

## Firms that cite its devices most
- Helix Medical, Inc.: 1 (https://510kreport.com/company/helix-medical)
- Freudenberg Medical, LLC: 1 (https://510kreport.com/company/freudenberg-medical)

## Its most-cited devices
- K971244: Provox 2 Voice Prosthesis System (1997), cited by 3
- K022125: Provox Freehands Hme, Model 7710 (2002), cited by 2
- K014102: Provox Hme Cassette, Model 7240; Provox Adhesive, Model 7251 (2002), cited by 2
- K131947: Provox Vega Puncture Set (2013), cited by 1
- K090455: Provox Vega, Model 8130-8135 (2009), cited by 1
- K940638: Provox (TM) Voice Prosthesis (1994), cited by 1

## Recent decisions
- K151404: ProTrach Dualcare (Feb 12, 2016)
- K141380: Provox Freehands Flexivoice (Sep 26, 2014)
- K131947: Provox Vega Puncture Set (Oct 18, 2013)
- K092593: Provox Activalve (Size 4.5MM, 6MM, 8MM, 10MM, 12.5MM) (Oct 14, 2010)
- K090455: Provox Vega, Model 8130-8135 (Jun 5, 2009)
- K072582: Provox Micron Hme (May 30, 2008)
- K043138: Provox Nid Voice Rehabilitation System, Model Ref 7101 to 7134 (Nov 22, 2004)
- K022125: Provox Freehands Hme, Model 7710 (Jul 30, 2002)

Source page: https://510kreport.com/company/atos-medical