MED-TECH RADIOLUCENT HEAD FIXATION SYSTEM— 510(k) K893911

Substantially Equivalent

Medical Equipment Development Co., Inc.

FDA 510(k) clearance K893911 for MED-TECH RADIOLUCENT HEAD FIXATION SYSTEM, Substantially Equivalent on 1989-08-29. Applicant: Medical Equipment Development Co., Inc..

Clearance details

Applicant: Medical Equipment Development Co., Inc.
Product code: Code HBL
Advisory panel: Neurology
Date received: 1989-05-30
Decision date: 1989-08-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Cinnaminson, NJ, US

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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.