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SIEMENS HEALTHCARE

UROSKOP OMNIA · General and Plastic Surgery

510(k): 0 Recall: 0 UDI: 1 MAUDE: 10 Class.: 0

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Siemens Healthcare Diagnostics, Inc. — Aptio Automation Storage and Retrieval Module (SRM)

HIGH · FDA · 2023-05-16

UDI Registrations (1)

Uroskop Omnia Max

Diagnostic Urology

MAUDE Adverse Events (10)

Malfunction

20230929

Malfunction

20230911

Malfunction

20230904

Injury

20230314

Malfunction

20230131

Injury

20220620

Malfunction

20210713

Malfunction

20210625

Malfunction

20201211

Malfunction

20200727