Data / Medical devices / Poland / Getinge AB
Getinge AB: FDA-registered device maker in POZNAN Wielkopolskie, Poland, 19 510(k) clearances
Getinge AB is registered with the FDA (registration 3031563141) in POZNAN Wielkopolskie, Poland. It lists 23 device types. The FDA files 19 510(k) clearances under its listings, the newest dated May 18, 2022. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3031563141
- Address
- Kopanina 30a, POZNAN Wielkopolskie, Poland, 60-105
- Owner or operator
- Getinge AB (10090886)
- Roles
- Complaint file establishment
- First device listed
- May 28, 2024
- Registered through
- 2026
- Brand names listed
- 1180 52A0 Multimodality Headrest, Fixed, 1180.12F0 Multimodality Transfer Table Top, 1180.71C0 Transfer Board, ALPHACLASSIC, ALPHAMAQUET, ALPHAMAXX, ALPHASTAR, ALPHASTAR PRO and more
Devices it lists
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 |
|---|---|---|---|---|---|---|
| May 18, 2022 | K214120 | GSS610N21 Series Steam Sterilizer | FLE | Substantially Equivalent | Maquet GmbH | accessdata.fda.gov |
| March 1, 2021 | K201927 | Getinge GSS610N Series Steam Sterilizer | FLE | Substantially Equivalent | Maquet GmbH | accessdata.fda.gov |
| January 30, 2018 | K172159 | Getinge GSS67N Series Steam Sterilizer | FLE | Substantially Equivalent | Maquet GmbH | accessdata.fda.gov |
| June 7, 2016 | K153713 | Getinge Series Warming Cabinet | LHC | Substantially Equivalent | Getinge Sourcing, LLC | accessdata.fda.gov |
| May 22, 2013 | K122625 | GETINGE 800HC- SERIES STEAM STERILIZER | FLE | Substantially Equivalent | Getinge Sourcing, LLC | accessdata.fda.gov |
| May 8, 2013 | K130513 | VOLISTA 400; VOLISTA 600 | FTD | Substantially Equivalent | Maquet S.A.S. | accessdata.fda.gov |
| March 12, 2013 | K122071 | GETINGE 400HC-E / SERIES STEAM STERILIZER | FLE | Substantially Equivalent | Getinge Sourcing, LLC | accessdata.fda.gov |
| May 31, 2012 | K120441 | GETINGE 700HC-E SERIES STEAM STERILIZER | FLE | Substantially Equivalent | Getinge Sourcing, LLC | accessdata.fda.gov |
| January 12, 2012 | K113679 | LUCEA LED SURGICAL LIGHT SYSTEM | NTN | Substantially Equivalent | Maquet S.A.S. | accessdata.fda.gov |
| April 5, 2007 | K070657 | GETINGE 633HC SERIES VACUUM/GRAVITY STEAM STERILIZER | FLE | Substantially Equivalent | Getinge Sourcing, LLC | accessdata.fda.gov |
| March 16, 2007 | K070442 | POWERLED SURGICAL LIGHT SYSTEM | FSY | Substantially Equivalent | Maquet S.A. | accessdata.fda.gov |
| May 21, 2004 | K040735 | ALM X'TEN (X10) SURGICAL LIGHT SYSTEM | FSY | Substantially Equivalent | Alm S.A. | accessdata.fda.gov |
| January 21, 2004 | K040015 | MODIFICATION TO PRISMALIX SURGICAL LIGHT | FSY | Substantially Equivalent | Alm S.A. | accessdata.fda.gov |
| April 23, 2003 | K030906 | AXCEL SURGICAL LIGHT | FSY | Substantially Equivalent | Alm | accessdata.fda.gov |
| September 22, 1998 | K982063 | ALM PRISMALIX (PRX) SURGICAL LIGHT | FSY | Substantially Equivalent | Alm Surgical Equipment, Inc. | accessdata.fda.gov |
| April 16, 1997 | K970886 | HANAULUX BLUE 80 HOSPITAL | FSS | Substantially Equivalent | Heraeus Med GmbH | accessdata.fda.gov |
| February 1, 1996 | K954169 | HANAULUX BLUE 30 & 80 | FSY | Substantially Equivalent | Heraeus Med GmbH | accessdata.fda.gov |
| November 12, 1993 | K932451 | HANAULUX 2005 SURGICAL LIGHT | FTD | Substantially Equivalent | Heraeus Instruments GmbH | accessdata.fda.gov |
| October 13, 1989 | K895715 | HANAULUX(R) 2000 | FTD | Substantially Equivalent | W.C. Heraeus GmbH | accessdata.fda.gov |
Compare with other makers
- All makers of Device, Medical Examination, Ac Powered
- All makers of Table, Radiologic
- All makers of Light, Surgical, Ceiling Mounted
- All makers of Surgical Table Cushion
- All makers of Light, Surgical, Floor Standing
- All makers of Stretcher, Wheeled
Updated May 18, 2022. 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.