FIXIT HEADREST CLAMP SYSTEM— 510(k) K083803

Substantially Equivalent

Medicon EG

FDA 510(k) clearance K083803 for FIXIT HEADREST CLAMP SYSTEM, Substantially Equivalent on 2010-03-10. Applicant: Medicon EG.

Clearance details

Applicant: Medicon EG
Product code: Code HBL
Advisory panel: Neurology
Date received: 2008-12-22
Decision date: 2010-03-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Tuttlingen, DE

Download summary PDF View on FDA.gov ↗

Adverse events under product code HBL

product code HBL

Death: 3
Injury: 753
Malfunction: 1,421
Total: 2,177

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.