FDA Product Code
FDA Product Code MAH — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Ear, Nose, Throat
- 21 CFR Citation
- 874.3302
510(k) Clearances — 12 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K261142 | Ponto 5 Mini; Ponto 5 Superpower | Oticon Medical AB | 2026-08-26 | Special | PDF ↗ |
| K203807 | Ponto Bone Anchored Hearing System, MONO Surgery Kit | Oticon Medical AB | 2021-03-03 | Special | PDF ↗ |
| K182116 | BA310 Abutment, BIA310 Implant/Abutment | Cochlear Americas | 2018-12-19 | Traditional | PDF ↗ |
| K152820 | Ponto Bone Anchored Hearing System | Oticon Medical AB | 2016-01-22 | Traditional | PDF ↗ |
| K152067 | Ponto bone anchored hearing system | Oticon Medical AB | 2015-11-23 | Traditional | PDF ↗ |
| K150555 | BA400 14mm Abutment | Cochlear Americas | 2015-07-15 | Traditional | PDF ↗ |
| K142678 | Ponto Bone Anchored Hearing system/ Abutment, 14mm. Ponto Bone Anchored Hearing System / Wide implant, 4mm, with abutment, 14 mm | Oticon Medical AB | 2015-01-21 | Traditional | PDF ↗ |
| K121317 | COCHLEAR BAHA IMPLANT SYSTEM | Cochlear Americas | 2012-10-12 | Traditional | PDF ↗ |
| K121228 | PONTO BONE ANCHORED HEARING SYSTEM | Oticon Medical AB | 2012-09-07 | Traditional | PDF ↗ |
| K112053 | OBC BONE ANCHORED HEARING SYSTEM | Oticon Medical AB | 2011-11-18 | Traditional | PDF ↗ |
| K080363 | BAHA CORDELLE II | Cochlear Bone Anchored Systems AB | 2008-04-10 | Traditional | PDF ↗ |
| K984162 | BRANEMARK BONE-ANCHORED HEARING AID (BAHA) SYSTEM FOR PEDIATRIC USE | Nobelpharma USA, Inc. | 1999-06-28 | Traditional | PDF ↗ |
Product code MAH · Class II · Ear, Nose, Throat. Data: openFDA.