REPROCESSED DYONICS ARTHROSCOPIC SHAVERS— 510(k) K012611

Substantially Equivalent

Alliance Medical, Inc.

FDA 510(k) clearance K012611 for REPROCESSED DYONICS ARTHROSCOPIC SHAVERS, Substantially Equivalent on 2001-11-07. Applicant: Alliance Medical, Inc..

Clearance details

Applicant: Alliance Medical, Inc.
Product code: Code HRX
Advisory panel: Orthopedic
Date received: 2001-08-13
Decision date: 2001-11-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Phoenix, AZ, 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.