FMS VUE II Fluid Management and Tissue Debridement System— 510(k) K171237

Substantially Equivalent

Medos International SARL

FDA 510(k) clearance K171237 for FMS VUE II Fluid Management and Tissue Debridement System, Substantially Equivalent on 2018-01-18. Applicant: Medos International SARL.

Clearance details

Applicant: Medos International SARL
Product code: Code HRX
Advisory panel: Orthopedic
Date received: 2017-04-27
Decision date: 2018-01-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Le Locle, CH

Download summary PDF View on FDA.gov ↗

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.