483
Pausch Medical GmbHPausch Medical GmbH – FDA 483, Feb 24, 2023
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.
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ID · 2c91298d-bfab-47c5-b38f-79efd6435df4
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