HEMEDEX CRANIAL BOLT MODELS, 3601, 3602— 510(k) K032337

Substantially Equivalent

Hemedex Incorporated

FDA 510(k) clearance K032337 for HEMEDEX CRANIAL BOLT MODELS, 3601, 3602, Substantially Equivalent on 2003-10-21. Applicant: Hemedex Incorporated.

Clearance details

Applicant: Hemedex Incorporated
Product code: Code GWM
Advisory panel: Neurology
Date received: 2003-07-29
Decision date: 2003-10-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hopkonton, MA, US

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Adverse events under product code GWM

product code GWM

Death: 21
Injury: 732
Malfunction: 2,063
Other: 1
Total: 2,817

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.