Home › Device types › OAF
Implant, Hearing, Active, Middle Ear, Totally Implanted
FDA product code OAF · Class 3 · Unknown
54
Registered devices
287
Adverse events
2
Recalls
0
510(k) clearances
Devices with this code
Esteem® Sound Processor — Envoy Medical CorporationEsteem® Sensor Replica — Envoy Medical CorporationEsteem® Intraoperative System Analyzer — Envoy Medical CorporationEsteem® Intraoperative System Analyzer — Envoy Medical CorporationEsteem® Sound Processor Replica — Envoy Medical CorporationEsteem® Ear Insert Assembly — Envoy Medical CorporationEsteem® IS-1 Lead End Cap — Envoy Medical CorporationEsteem® MedCem® — Envoy Medical CorporationEsteem® Driver — Envoy Medical CorporationEsteem® Driver Replica — Envoy Medical CorporationEsteem® Tapered Syringe Tips — Envoy Medical CorporationEsteem® Bone Screws — Envoy Medical CorporationEsteem® Driver — Envoy Medical CorporationEsteem® Commander™ — Envoy Medical CorporationEsteem® Transducer Replica — Envoy Medical CorporationEsteem MedCem — Envoy Medical CorporationEsteem® Intraoperative System Analyzer — Envoy Medical CorporationEsteem® Intraoperative System Analyzer — Envoy Medical CorporationEsteem® Sound Processor — Envoy Medical CorporationEsteem® Surgical Tools Kit — Envoy Medical CorporationEsteem® Intraoperative System Analyzer — Envoy Medical CorporationEsteem® MedCem® — Envoy Medical CorporationEsteem® Laser Light Guide — Envoy Medical CorporationEsteem® Sensor — Envoy Medical Corporation
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2018-06-28 | Envoy Medical Corporation | Sterile Wipes packed in these four Esteem II Sound Processors had an earlier expiration date than the final pack and the Esteem II Sound Processors. The Sterile |
| 2013-01-09 | Envoy Medical Corporation | Envoy Medical is conducting a voluntary correction of a limited number of Esteem Programmers, part of the Esteem Totally Implantable Hearing System, to reduce t |
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