REMA SHAVER BLADES— 510(k) K060172

Substantially Equivalent

Rema Medizintechnik GmbH.

FDA 510(k) clearance K060172 for REMA SHAVER BLADES, Substantially Equivalent on 2006-05-31. Applicant: Rema Medizintechnik GmbH..

Clearance details

Applicant: Rema Medizintechnik GmbH.
Product code: Code HRX
Advisory panel: Orthopedic
Date received: 2006-01-23
Decision date: 2006-05-31
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Ft. Lauderdale, FL, US

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.