BRANEMARK BONE-ANCHORED HEARING AID (BAHA) CORDELLE II— 510(k) K992872
Substantially EquivalentEntific Medical Systems, Inc.
FDA 510(k) clearance K992872 for BRANEMARK BONE-ANCHORED HEARING AID (BAHA) CORDELLE II, Substantially Equivalent on 1999-11-24. Applicant: Entific Medical Systems, Inc..
Clearance details
- Applicant
- Entific Medical Systems, Inc.
- Product code
- Code LXB
- Advisory panel
- Ear, Nose, Throat
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Skokie, IL, US
Adverse events under product code LXB
product code LXB- Injury
- 2,334
- Total
- 2,334
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.