BONE INJECTION GUN (B.I.G.)— 510(k) K062940

Substantially Equivalent

Waismed, Ltd.

FDA 510(k) clearance K062940 for BONE INJECTION GUN (B.I.G.), Substantially Equivalent on 2006-12-22. Applicant: Waismed, Ltd..

Clearance details

Applicant: Waismed, Ltd.
Product code: Code FMI
Advisory panel: General Hospital
Date received: 2006-09-28
Decision date: 2006-12-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Washington, DC, US

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Adverse events under product code FMI

product code FMI

Death: 28
Injury: 1,517
Malfunction: 23,981
Other: 18
Total: 25,544

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.