K921822

Substantially Equivalent

FRAY BIO-PUNCH

Applicant: Fray Products Corp.
Product code: MDM
Advisory panel: General, Plastic Surgery
Date received: 1992-04-16
Decision date: 1992-10-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Tonawanda, NY, 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.