PAUSCH Medical GmbH

ERLANGEN Bavaria, DE

PAUSCH Medical GmbH appears in FDA device records in ERLANGEN Bavaria, DE. FDA records list 3 510(k) clearances between 2016-08-17 and 2023-01-26, no PMA records and one registered establishment. As of 2026-09-10, FDA records show one recall for this company, and at least one establishment registration is current.

510(k) clearances: 3
PMA records: 0
Recall records: 1
Registered establishments: 1

FDA records under these names

1 name

FDA records resolved to PAUSCH Medical GmbH carry these names as well, as FDA wrote them. Each is the firm named on a registration, a 510(k), a PMA, a recall or an enforcement report that was joined to this company on a shared FDA identifier or on a matching name.

Hans Pausch Rontgengeratebau Gmbhenforcement report, recall

510(k) clearance history

FDA records hold 3 510(k) clearances for PAUSCH Medical GmbH between 2016 and 2023. The busiest year on record is 2016, with 1. The most recent is 2023, with 1.

Clearances by year, as a table

510(k) clearance decisions for PAUSCH Medical GmbH, by decision year
Year	Clearances
2016	1
2018	1
2023	1

510(k) clearances on record, most recent first
K number	Device	Product code	Decision	Decision date
K221949	Ortho Device, ADAPTIX 3D Orthopedic Imaging System	IZF	Substantially Equivalent	2023-01-26
K180651	Uroview FD II	JAA	Substantially Equivalent	2018-04-12
K161019	Uroview FD	JAA	Substantially Equivalent	2016-08-17

Registered establishments

FDA registered establishments for PAUSCH Medical GmbH, with the product codes listed at each
Registration	FEI	Establishment	Address	Registration expires	Product codes listed
9610903	3002807145	PAUSCH Medical GmbH	GRAF-ZEPPELIN-STRASSE 1, ERLANGEN Bavaria 91056 DE	2026	IXR IXY IYB JAA KQS

Registration numbers link to the FDA registration and listing record for that establishment.

FDA product codes

Recall records

Device recall records naming this company, most recent first
Recall	Product	Reason	Classification	Initiated	Status
Z-2152-2017	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 includes a radiologic / urologic treatment table, maybe used for urological treatment, planning and diagnostic procedures, including but not limited to.	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 only with this footswitch X-ray should be activated.	Class II	2017-03-14	Terminated

Verification record

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Data as of 2026-09-28, FDA export datePage updated 2026-09-05Source: openFDA, public domain