FDA Device Intelligence
HomeSOPRO-COMEG GmbH › Urology syringe

Urology syringe

SOPRO-COMEG GmbH · Model 199 090 100 C · UDI-DI 04059082010908

FJL
1
510(k) clearances
940
Adverse events (5 deaths)
33
Recalls
40
Facilities

Recalls

DateFirmReason
2025-11-11Olympus Corporation of the AmericasComplaints of the ceramic tip of the resection sheath breaking have been received.
2025-11-11Olympus Corporation of the AmericasComplaints of the ceramic tip of the resection sheath breaking have been received.
2025-11-11Olympus Corporation of the AmericasComplaints of the ceramic tip of the resection sheath breaking have been received.
2025-11-11Olympus Corporation of the AmericasComplaints of the ceramic tip of the resection sheath breaking have been received.
2025-11-11Olympus Corporation of the AmericasComplaints of the ceramic tip of the resection sheath breaking have been received.
2025-11-11Olympus Corporation of the AmericasComplaints of the ceramic tip of the resection sheath breaking have been received.
2025-11-11Olympus Corporation of the AmericasComplaints of the ceramic tip of the resection sheath breaking have been received.
2025-11-11Olympus Corporation of the AmericasComplaints of the ceramic tip of the resection sheath breaking have been received.
2025-11-11Olympus Corporation of the AmericasComplaints of the ceramic tip of the resection sheath breaking have been received.
2025-11-11Olympus Corporation of the AmericasComplaints of the ceramic tip of the resection sheath breaking have been received.

Query this across every FDA database — by API.

Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.

Get your free API keyRead the docs
Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.