Pausch Medical GmbHFebruary 24, 2023

FDA 483 - Pausch Medical GmbH - February 24, 2023

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Record Details

An FDA inspection of Pausch Medical GmbH in Erlangen, Germany, revealed a significant issue regarding product reporting. The firm failed to submit required product reports and obtain accession numbers for its Uroview FD and Uroview FD II fluoroscopic x-ray medical device systems prior to their introduction into U.S. commerce. This indicates a serious lapse in regulatory compliance for distributed medical devices.

Company: Pausch Medical GmbH
Inspection Date: February 24, 2023
Product Type: Device
Office: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
Person: Eric C. Schmitt

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ID · 2c91298d-bfab-47c5-b38f-79efd6435df4