K052505
Substantially EquivalentCALF IMPLANT, MODEL EC17-X
- Applicant
- Implantech Associates, Inc.
- Product code
- MIB
- Advisory panel
- Ear, Nose, Throat
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Ventura, CA, US
Adverse events under product code MIB
product code MIB- Injury
- 146
- Total
- 146
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.