Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

8010652

FEI Number

1841

Entity Name

MAQUET GMBH

City/State/Country

RASTATT Baden-Wurttemberg, DE

Establishment Address

KEHLER STRASSE 31, RASTATT Baden-Wurttemberg 76437, DE

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

MAQUET GMBH (Owner Number: 8010652)

Owner / Operator Contact Address

KEHLER STRASSE 31, --, RASTATT, DE-BW 76437, DE

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

GSS610N10, GSS610N14, GSS610N15 Steam Sterilizer 1180.12F0 Multimodality Transfer Table Top 1180.71C0 Transfer Board ALPHASTAR; YUNO; ALPHAMAXX; ALPHASTAR PRO; MAGNUS; ALPHAMAQUET; BETASTAR; ALPHACLASSIC; OTESUS; MEERA YUNO II GSS610N21 Series Steam Sterilizer Rigid Head Rest 1002.82A0 1180.52A0 Multimodality Headrest, Fixed MAQUET MAGNUS carbon-fibre table top (1180.16XX; T285.7000) YUNO Femur Hook Transmobile TT, Transmobile TT-M Gel pads Accessories to YUNO; ALPHAMAXX; ALPHASTAR PRO; MAGNUS; ALPHAMAQUET; BETASTAR; ALPHACLASSIC; OTESUS; MEERA YUNO II TRIMANO Fortis TRIMANO OTESUS ALPHACLASSIC MEERA, MEERA ST, MEERA CL BETASTAR ALPHASTAR PRO MAGNUS YUNO ALPHASTAR ORTHOSTAR MAQUET OPERATING TABLES ALPHAMAXX ALPHAMAQUET YUNO II CORIN

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
FLE	Sterilizer, Steam	General Hospital	Class 2	880.6880	2021-03-10
IXQ	Table, Radiographic, Stationary Top	Radiology	Class 2	892.1980	2018-11-16
JEA	Table, Surgical With Orthopedic Accessories, Ac-Powered	General, Plastic Surgery	Class 1	878.4960	2016-10-18
FLE	Sterilizer, Steam	General Hospital	Class 2	880.6880	2023-02-28
IWY	Holder, Head, Radiographic	Radiology	Class 1	892.1920	2016-01-28
KXJ	Table, Radiologic	Radiology	Class 2	892.1980	2001-09-24
KIK	Hook, Bone	General, Plastic Surgery	Class 1	878.4800	2012-05-09
FPO	Stretcher, Wheeled	General Hospital	Class 2	880.6910	2004-08-20
LWG	Surgical Table Cushion	General, Plastic Surgery	Class 1	878.4950	2015-07-30
BWN	Table And Attachments, Operating-Room	General, Plastic Surgery	Class 1	878.4950	2016-10-18
FQO	Table, Operating-Room, Ac-Powered	General, Plastic Surgery	Class 1	878.4960	2001-11-27

Official Correspondent

No official correspondent registered.

US Agent Details

Emily Valerio Email: emily.valerio@getinge.com Phone: (862) 2215193

Related Public Records

Same Entity

MAQUET GMBH

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K021223	Sauter AG	BELIMED STEAM STERILIZER, MODEL TOP 5000	2002-06-26
K050263	M.O. Com S.R.L.	MILLENNIUM SERIES, INCLUDING MILLENNIUM B, B+, B2 AND BU	2006-11-21
K812396	Northwest Surgical Concepts, Inc.	ARTHRO-PREP REST	1981-11-20

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0040-2017	Trumpf Medical Systems, Inc.	1	Mobile Column TruSystem 7500, Material Number 1717023; Mobile Column TruSystem 5500, Material Number 1607822 Patient positioning during surgery, ranging from anesthesia induction to actual surgery to recover from the anesthesia. Also, patient transport on the operating table top from a patient transfer system to the operating theater of from the operating theater to a patient transfer system
Z-0041-2017	Trumpf Medical Systems, Inc.	1	Stationary Column TruSystem 7599, Material Number 1717020 Patient positioning during surgery, ranging from anesthesia induction to actual surgery to recover from the anesthesia. Also, patient transport on the operating table top from a patient transfer system to the operating theater of from the operating theater to a patient transfer system.
Z-0042-2017	Trumpf Medical Systems, Inc.	1	Floor Mounting Column TS 7500 U, Material Number 1730732; Floor Mounting Column ARTIS, Material Number 1501878 Patient positioning during surgery, ranging from anesthesia induction to actual surgery to recover from the anesthesia. Also, patient transport on the operating table top from a patient transfer system to the operating theater of from the operating theater to a patient transfer system.
Z-0043-2017	Trumpf Medical Systems, Inc.	1	Operating Table TruSystem 7000 U, Material Number 1604788; Operating Table TruSystgem 7000 U (MB), Material Number 1604786 Patient positioning during surgery, ranging from anesthesia induction to actual surgery to recover from the anesthesia. Also, patient transport on the operating table top from a patient transfer system to the operating theater of from the operating theater to a patient transfer system
Z-0023-05	Stryker Medical	2	Stryker brand Rugged EZ-Pro R4 Ambulance Cot, model 6092.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 8010652. Last updated year: 2026. Please use registration number 8010652 when referencing this establishment in official correspondence.