K873848

Substantially Equivalent

RETROBULBAR NEEDLE

Applicant: Healthtek, Inc.
Product code: GDM
Advisory panel: General, Plastic Surgery
Date received: 1987-09-22
Decision date: 1987-10-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Nevada City, CA, US

Adverse events under product code GDM

product code GDM

Death: 2
Total: 2

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.