Data / Medical devices / Sweden / Atos Medical AB

Atos Medical AB: FDA-registered device maker in HORBY Skane, Sweden, 10 510(k) clearances

Name: Atos Medical AB FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Atos Medical AB is registered with the FDA (registration 8032044) in HORBY Skane, Sweden. It lists 17 device types. The FDA files 10 510(k) clearances under its listings, the newest dated February 12, 2016. 1 recall event names it as the recalling firm. Registered through 2027. FDA data exported November 2, 2026.

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FDA registration number: 8032044
FEI number: 3002806269
Address: Kraftgatan 8, HORBY Skane, Sweden, SE-24235
Owner or operator: ATOS MEDICAL AB (8032044)
Roles: Manufacturer
First device listed: January 9, 1997
Registered through: 2027
Brand names listed: ActiValve Lubricant, Freevent Connection Strap, Freevent Dressing Softfoam L, Freevent Dressing Softfoam S, Freevent Dressing Softfoam Slim, Freevent DualCare Set 15, Freevent DualCare Set 22, Freevent DualCare Speaking Valve and more

Devices it lists

Device	Product code	Class	Role	Source
Bandage, Liquid, Skin Protectant	NEC	1	Manufacturer	accessdata.fda.gov
Brush, Cleaning, Tracheal Tube	EPE	1	Manufacturer	accessdata.fda.gov
Condenser, Heat And Moisture (Artificial Nose)	BYD	1	Manufacturer	accessdata.fda.gov
Device, Fixation, Tracheal Tube	CBH	1	Manufacturer	accessdata.fda.gov
Dressing, Wound, Hydrophilic	NAC	1	Manufacturer	accessdata.fda.gov
Dressing, Wound, Occlusive	NAD	1	Manufacturer	accessdata.fda.gov
Exerciser, Non-Measuring	ION	1	Manufacturer	accessdata.fda.gov
Forceps, Ent	KAE	1	Manufacturer	accessdata.fda.gov
Instrument, Ent Manual Surgical	LRC	1	Manufacturer	accessdata.fda.gov
Larynx, Artificial (Battery-Powered)	ESE	1	Manufacturer	accessdata.fda.gov
Prosthesis, Adhesive, External	GBJ	1	Manufacturer	accessdata.fda.gov
Prosthesis, Laryngeal (Taub)	EWL	2	Manufacturer	accessdata.fda.gov
Solvent, Adhesive Tape	KOX	1	Manufacturer	accessdata.fda.gov
Tape And Bandage, Adhesive	KGX	1	Manufacturer	accessdata.fda.gov
Tracheostomy Kit	OGW	2	Manufacturer	accessdata.fda.gov
Tube Tracheostomy And Tube Cuff	JOH	2	Manufacturer	accessdata.fda.gov
Tube, Laryngectomy	KAC	1	Manufacturer	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
February 12, 2016	K151404	ProTrach Dualcare	JOH	Substantially Equivalent	Atos Medical AB	accessdata.fda.gov
September 26, 2014	K141380	PROVOX FREEHANDS FLEXIVOICE	EWL	Substantially Equivalent	Atos Medical AB	accessdata.fda.gov
October 18, 2013	K131947	PROVOX VEGA PUNCTURE SET	EWL	Substantially Equivalent	Atos Medical AB	accessdata.fda.gov
October 14, 2010	K092593	PROVOX ACTIVALVE (SIZE 4.5MM, 6MM, 8MM, 10MM, 12.5MM)	EWL	Unknown	Atos Medical AB	accessdata.fda.gov
June 5, 2009	K090455	PROVOX VEGA, MODEL 8130-8135	EWL	Substantially Equivalent	Atos Medical AB	accessdata.fda.gov
May 30, 2008	K072582	PROVOX MICRON HME	JOH	Substantially Equivalent	Atos Medical AB	accessdata.fda.gov
November 22, 2004	K043138	PROVOX NID VOICE REHABILITATION SYSTEM, MODEL REF 7101 TO 7134	EWL	Substantially Equivalent	Atos Medical AB	accessdata.fda.gov
February 21, 2002	K014102	PROVOX HME CASSETTE, MODEL 7240; PROVOX ADHESIVE, MODEL 7251	JOH	Substantially Equivalent	Atos Medical AB	accessdata.fda.gov
June 6, 1997	K971244	PROVOX 2 VOICE PROSTHESIS SYSTEM	EWL	Substantially Equivalent	Atos Medical AB	accessdata.fda.gov
June 22, 1994	K940638	PROVOX(TM) VOICE PROSTHESIS	EWL	Substantially Equivalent	Atos Medical AB	accessdata.fda.gov

Recalls

Recall events where this establishment is the recalling firm, matched on its FEI.

Initiated	Event	Class	Status	Product	Reason	Source
March 29, 2021	87635	Class II	Terminated	Provox Life Night HME, Catalogue Number 8262 - Product Usage: single use heat and moisture exchangers for patients breathing through a tracheostoma.	Provox Life Night HME may be incorrectly inserted sideways or forcefully through the adhesive coupling potentially occluding or blocking the stoma.	accessdata.fda.gov

Compare with other makers

Updated February 12, 2016. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.