Phasix Mesh— 510(k) K142818
Substantially EquivalentC. R. Bard
FDA 510(k) clearance K142818 for Phasix Mesh, Substantially Equivalent on 2015-03-31. Applicant: C. R. Bard. Device class: 2.
Clearance details
- Applicant
- C. R. Bard
- Product code
- Code OOD
- Device class
- Class 2
- Regulation
- 21 CFR 878.3300
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Warwick, RI, US
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Adverse events under product code OOD
product code OOD- Death
- 6
- Injury
- 1,005
- Total
- 1,011
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.