K081142
Substantially EquivalentAUTO-BAND LIGATOR
- Applicant
- Scandimed International
- Product code
- MND
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Glostrop, DK
Adverse events under product code MND
product code MND- Death
- 6
- Injury
- 255
- Malfunction
- 4,495
- Total
- 4,756
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.