Graft Delivery Device with Integrated Stylet— 510(k) K151543
Substantially EquivalentMicromedics, Inc. (D/B/A Nordson Medical)
FDA 510(k) clearance K151543 for Graft Delivery Device with Integrated Stylet, Substantially Equivalent on 2015-07-07. Applicant: Micromedics, Inc. (D/B/A Nordson Medical).
Clearance details
- Applicant
- Micromedics, Inc. (D/B/A Nordson Medical)
- Product code
- Code FMF
- Advisory panel
- General Hospital
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- St. Paul, MN, US
Adverse events under product code FMF
product code FMF- Death
- 15
- Injury
- 2,263
- Malfunction
- 29,722
- Other
- 17
- Total
- 32,017
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.