K950370

Substantially Equivalent

ULTRACELL ORTHOPEDIC SPONGES

Applicant: Ultracell Medical Technologies, Inc.
Product code: GDY
Advisory panel: General, Plastic Surgery
Date received: 1995-01-31
Decision date: 1995-04-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Old Mystic, CT, US

Adverse events under product code GDY

product code GDY

Malfunction: 764
Total: 764

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.