THE NEEDLE CATCHER— 510(k) K051281
Substantially EquivalentE.D.Medical , Ltd.
FDA 510(k) clearance K051281 for THE NEEDLE CATCHER, Substantially Equivalent on 2005-09-08. Applicant: E.D.Medical , Ltd..
Clearance details
- Applicant
- E.D.Medical , Ltd.
- Product code
- Code HTD
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Belfast, GB
Adverse events under product code HTD
product code HTD- Malfunction
- 892
- Total
- 892
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.