FDA.reportPublic FDA data

ATOS MEDICAL, INC.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
21351363007501574ATOS MEDICAL, INC.1Y2026-01-012230 S 162nd St New Berlin WI US 53151
80320443002806269ATOS MEDICAL AB1N2026-01-01KRAFTGATAN 8 HORBY Skane SE SE-24235
21351363007501574ATOS MEDICAL, INC.1Y2020-04-252801 S Moorland Rd New Berlin WI US 53151

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDID, Product, Phone table
Source GUDIDProductPhoneEmail
07331791008320HME DigiTop O2 - The HME DigiTop O2 is an accessory to Freevent HMEs and Provox FreeHands HME's. For patients spontaneously breathing through a tracheostoma and having a need of extra oxygen.+4641519800info@atosmedical.com
07331791010309Provox FlexiDerm Round (3pcs) - The Provox Adhesives are single use devices intended for laryngectomized patients breathing through a tracheostoma. The devices are attached to the skin around the tracheostoma in order to provide attachment of components of the Provox HME System.+4641519800info@atosmedical.com
07331791010316Provox FlexiDerm Oval (3 pcs) - The Provox Adhesives are single use devices intended for laryngectomized patients breathing through a tracheostoma. The devices are attached to the skin around the tracheostoma in order to provide attachment of components of the Provox HME System.+4641519800info@atosmedical.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
110261224448296K971244PROVOX 2 VOICE PROSTHESIS SYSTEMEWL1997-06-06
110261511940733K940638PROVOX(TM) VOICE PROSTHESISEWL1994-06-22
110261443467494K151404ProTrach DualcareJOH2016-02-12
110261793078609K141380PROVOX FREEHANDS FLEXIVOICEEWL2014-09-26
110261034847053K131947PROVOX VEGA PUNCTURE SETEWL2013-10-18
110261858402626K092593PROVOX ACTIVALVE (SIZE 4.5MM, 6MM, 8MM, 10MM, 12.5MM)EWL2010-10-14
110261871395635K090455PROVOX VEGA, MODEL 8130-8135EWL2009-06-05
110261167261760K072582PROVOX MICRON HMEJOH2008-05-30
110261831672724K043138PROVOX NID VOICE REHABILITATION SYSTEM, MODEL REF 7101 TO 7134EWL2004-11-22
110262022265825K022125PROVOX FREEHANDS HME, MODEL 7710EWL2002-07-30
110261532947815K014102PROVOX HME CASSETTE, MODEL 7240; PROVOX ADHESIVE, MODEL 7251JOH2002-02-21
110261101603220
110271797408170
110261027798751
110261065048837
110261074778555
110261187230716
110261260185809
110261329033576
110261369406381
110261379302213
110261399091899
110261451964198
110261505807949
110261699504248
110261797408170
110261871815786
110262040461320

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
EWL82014-09-26
JOH32016-02-12

PMN#

GUDID#

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