MIZUHO RADIOLUCENT HEAD FRAME— 510(k) K955012

Substantially Equivalent

Mizuho America, Inc.

FDA 510(k) clearance K955012 for MIZUHO RADIOLUCENT HEAD FRAME, Substantially Equivalent on 1996-09-12. Applicant: Mizuho America, Inc..

Clearance details

Applicant: Mizuho America, Inc.
Product code: Code HBL
Advisory panel: Neurology
Date received: 1995-11-01
Decision date: 1996-09-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Beverly, MA, 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.