ARTHOSCOPY PUMP A115— 510(k) K033927

Substantially Equivalent

W.O.M. World of Medicine AG

FDA 510(k) clearance K033927 for ARTHOSCOPY PUMP A115, Substantially Equivalent on 2004-01-15. Applicant: W.O.M. World of Medicine AG.

Clearance details

Applicant: W.O.M. World of Medicine AG
Product code: Code HRX
Advisory panel: Orthopedic
Date received: 2003-12-18
Decision date: 2004-01-15
Decision: Substantially Equivalent
Clearance type: Special
Location: Alexandria, VA, US

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Adverse events under product code HRX

product code HRX

Injury: 623
Malfunction: 11,257
Total: 11,880

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.