Voyant 5mm Fusion Device, Voyant Maryland Fusion Device— 510(k) K193292
Substantially EquivalentApplied Medical Resources Corp.
FDA 510(k) clearance K193292 for Voyant 5mm Fusion Device, Voyant Maryland Fusion Device, Substantially Equivalent on 2019-12-20. Applicant: Applied Medical Resources Corp..
Clearance details
- Applicant
- Applied Medical Resources Corp.
- Product code
- Code GEI
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Rancho Santa, CA, US
Adverse events under product code GEI
product code GEI- Death
- 133
- Injury
- 7,585
- Malfunction
- 35,808
- Other
- 44
- Total
- 43,570
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.