OMNIMED CLAMP— 510(k) K851654

Substantially Equivalent

Omni Intl., Inc.

FDA 510(k) clearance K851654 for OMNIMED CLAMP, Substantially Equivalent on 1985-05-31. Applicant: Omni Intl., Inc..

Clearance details

Applicant: Omni Intl., Inc.
Product code: Code HXD
Advisory panel: General, Plastic Surgery
Date received: 1985-04-22
Decision date: 1985-05-31
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Palm Springs, CA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code HXD

product code HXD

Malfunction: 660
Total: 660

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.