K941193

Substantially Equivalent

EAST WEST INSTRUMENTS

Applicant: East West Instruments, Inc.
Product code: MDM
Advisory panel: General, Plastic Surgery
Date received: 1994-03-11
Decision date: 1994-11-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Aurora, IL, US

Adverse events under product code MDM

product code MDM

Injury: 247
Malfunction: 1,516
Total: 1,763

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.