BONE INJECTION GUN (B.I.G.) DEVICE— 510(k) K981853
Substantially EquivalentWaismed, Ltd.
FDA 510(k) clearance K981853 for BONE INJECTION GUN (B.I.G.) DEVICE, Substantially Equivalent on 1998-11-17. Applicant: Waismed, Ltd.. Device class: 2.
Clearance details
- Applicant
- Waismed, Ltd.
- Product code
- Code FMI
- Device class
- Class 2
- Regulation
- 21 CFR 880.5570
- Advisory panel
- General Hospital
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Ginot Shomron 44853, IL
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More clearances from Waismed, Ltd.
view allAdverse 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, through . 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.