Data / Medical devices / Germany / Maquet GMBH

Maquet GMBH: FDA-registered device maker in RASTATT Baden-Wurttemberg, Germany, 3 510(k) clearances

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

Maquet GMBH is registered with the FDA (registration 8010652) in RASTATT Baden-Wurttemberg, Germany. It lists 12 device types. The FDA files 3 510(k) clearances under its listings, the newest dated May 18, 2022. 1 recall event names it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 8010652
FEI number: 1841
Address: Kehler Strasse 31, RASTATT Baden-Wurttemberg, Germany, 76437
Owner or operator: MAQUET GMBH (8010652)
Roles: Manufacturer, Repackager or relabeler, Specification developer
First device listed: September 24, 2001
Registered through: 2026
Brand names listed: 1180.12F0 Multimodality Transfer Table Top, 1180.52A0 Multimodality Headrest, Fixed, 1180.71C0 Transfer Board, ALPHACLASSIC, ALPHAMAQUET, ALPHAMAXX, ALPHASTAR, ALPHASTAR PRO and more

Devices it lists

Device	Product code	Class	Role	Source
Headrest, Neurosurgical	HBM	1	Manufacturer	accessdata.fda.gov
Holder, Head, Radiographic	IWY	1	Manufacturer	accessdata.fda.gov
Hook, Bone	KIK	1	Manufacturer	accessdata.fda.gov
Sterilizer, Steam	FLE	2	Specification developer	accessdata.fda.gov
Stretcher, Wheeled	FPO	2	Manufacturer	accessdata.fda.gov
Surgical Table Cushion	LWG	1	Repackager or relabeler	accessdata.fda.gov
Table And Attachments, Operating-Room	BWN	1	Manufacturer, Repackager or relabeler, Specification developer	accessdata.fda.gov
Table, Operating-Room, Ac-Powered	FQO	1	Manufacturer	accessdata.fda.gov
Table, Operating-Room, Manual	FSE	1	Manufacturer	accessdata.fda.gov
Table, Radiographic, Stationary Top	IXQ	2	Manufacturer	accessdata.fda.gov
Table, Radiologic	KXJ	2	Manufacturer	accessdata.fda.gov
Table, Surgical With Orthopedic Accessories, Ac-Powered	JEA	1	Manufacturer, Repackager or relabeler, Specification developer	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
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

Recalls

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

Initiated	Event	Class	Status	Product	Reason	Source
July 14, 2025	97313	Class II	Ongoing	Corin Operating Tables Model Numbers: (1) 770001A0, (2) 770001A2, (3) 770001B0, (4) 770001B2, (5) 770001F0, (6) 770001F2; All Software Versions.	Under certain conditions, such as the simultaneous use of the operating table with other medical devices, including high-frequency (HF) surgical equipment, interference may occur that could prevent the device from performing as intended. If the issue occurs, the operating table is unresponsive to command from both the universal remote control and override pa	accessdata.fda.gov

Compare with other makers

Updated August 22, 2025. 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.