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PAUSCH Medical GmbH: FDA-registered device maker in ERLANGEN Bavaria, Germany, 2 510(k) clearances

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

PAUSCH Medical GmbH is registered with the FDA (registration 9610903) in ERLANGEN Bavaria, Germany. It lists 5 device types. The FDA files 2 510(k) clearances under its listings, the newest dated April 12, 2018. 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: 9610903
FEI number: 3002807145
Address: Graf-Zeppelin-Strasse 1, ERLANGEN Bavaria, Germany, 91056
Owner or operator: MAVIG GmbH (9009516)
Roles: Exporter to the US, Manufacturer
First device listed: November 22, 2013
Registered through: 2026
Brand names listed: Pausch Diagnostic x-ray tube mount, Pausch Radiologic table, Pausch Urological table, Pausch Wall-mounted radiographic cassette holder, Uroview FD, Uroview Fd Ii

Devices it lists

Device	Product code	Class	Role	Source
Holder, Radiographic Cassette, Wall-Mounted	IXY	1	Manufacturer	accessdata.fda.gov
System, X-Ray, Fluoroscopic, Image-Intensified	JAA	2	Exporter to the US, Manufacturer	accessdata.fda.gov
Table, Cystometric, Non-Electric And Accessories	KQS	1	Manufacturer	accessdata.fda.gov
Table, Radiographic, Tilting	IXR	2	Manufacturer	accessdata.fda.gov
Tube Mount, X-Ray, Diagnostic	IYB	1	Manufacturer	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
April 12, 2018	K180651	Uroview FD II	JAA	Substantially Equivalent	Pausch Medical GmbH	accessdata.fda.gov
August 17, 2016	K161019	Uroview FD	JAA	Substantially Equivalent	Pausch Medical 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
March 14, 2017	76808	Class II	Terminated	Pausch Uroview FD fluoroscopic X-ray system UDI number (01)04260491620040 Primarily for urological applications (functional X-ray diagnostics, endourology and minimal invasive urology / surgery). The system, which includ	During patient interventions with the urology table the radiation is activated with a footswitch connected to the table. This footswitch is actively involved in the safety circuit of the urological table. Only if footswitch + exposure + first primary barrier are closed the signal will be transmitted to the generator for activating X-ray. During intended use	accessdata.fda.gov

Compare with other makers

Updated April 12, 2018. 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.