Atos Medical AB
New Berlin, WI, US
ATOS MEDICAL AB appears in FDA device records in New Berlin, WI. FDA records list 15 510(k) clearances between and , no PMA records and 2 registered establishments. As of , FDA records show one recall for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 15 510(k) clearances for Atos Medical AB between 1990 and 2016. The busiest year on record is 1994, with 2. The most recent is 2016, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1990 | 1 |
| 1993 | 1 |
| 1994 | 2 |
| 1995 | 1 |
| 1997 | 1 |
| 2002 | 2 |
| 2004 | 1 |
| 2008 | 1 |
| 2009 | 1 |
| 2010 | 1 |
| 2013 | 1 |
| 2014 | 1 |
| 2016 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K151404 | ProTrach Dualcare | JOH | Substantially Equivalent | |
| K141380 | PROVOX FREEHANDS FLEXIVOICE | EWL | Substantially Equivalent | |
| K131947 | PROVOX VEGA PUNCTURE SET | EWL | Substantially Equivalent | |
| K092593 | PROVOX ACTIVALVE (SIZE 4.5MM, 6MM, 8MM, 10MM, 12.5MM) | EWL | Unknown | |
| K090455 | PROVOX VEGA, MODEL 8130-8135 | EWL | Substantially Equivalent | |
| K072582 | PROVOX MICRON HME | JOH | Substantially Equivalent | |
| K043138 | PROVOX NID VOICE REHABILITATION SYSTEM, MODEL REF 7101 TO 7134 | EWL | Substantially Equivalent | |
| K022125 | PROVOX FREEHANDS HME, MODEL 7710 | EWL | Substantially Equivalent | |
| K014102 | PROVOX HME CASSETTE, MODEL 7240; PROVOX ADHESIVE, MODEL 7251 | JOH | Substantially Equivalent | |
| K971244 | PROVOX 2 VOICE PROSTHESIS SYSTEM | EWL | Substantially Equivalent | |
| K942495 | SINOJET MAXILLARY SINUS PUNCTURE & IRRIGATION SYSTEM | KAM | Substantially Equivalent | |
| K940638 | PROVOX(TM) VOICE PROSTHESIS | EWL | Substantially Equivalent | |
| K936275 | TYMPOVENT | ETD | Substantially Equivalent | |
| K922145 | SINOJECT MAXILLARY SINUS PUNCTURE & IRRIGATION SYS | KAM | Substantially Equivalent | |
| K896630 | SINOVENT MAXILLARY SINUS DRAINAGE SYSTEM | KAM | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 8032044 | 3002806269 | ATOS MEDICAL AB | KRAFTGATAN 8, HORBY Skane SE-24235 SE | 2026 | and 7 more, listed in full below |
| 2135136 | 3007501574 | ATOS MEDICAL, INC. | 2230 S 162nd St, New Berlin, WI 53151 US | 2026 | No device listings on this registration |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- NECBandage, Liquid, Skin Protectant
- EPEBrush, Cleaning, Tracheal Tube
- KAMCannula, Sinus
- BYDCondenser, Heat And Moisture (Artificial Nose)
- CBHDevice, Fixation, Tracheal Tube
- NACDressing, Wound, Hydrophilic
- NADDressing, Wound, Occlusive
- IONExerciser, Non-Measuring
- KAEForceps, Ent
- LRCInstrument, Ent Manual Surgical
- ESELarynx, Artificial (Battery-Powered)
- GBJProsthesis, Adhesive, External
- EWLProsthesis, Laryngeal (Taub)
- KOXSolvent, Adhesive Tape
- KGXTape And Bandage, Adhesive
- OGWTracheostomy Kit
- JOHTube Tracheostomy And Tube Cuff
- KACTube, Laryngectomy
- ETDTube, Tympanostomy
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-1548-2021 | 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. | Class II | Terminated |
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain