Panels › Ear, Nose, Throat › Product code PFO · Class 2
Active Implantable Bone Conduction Hearing System
Regulation 874.3340
1510(k)s in 12 months (12 all time)
0recalls in 12 months (0 all time)
0recalls that name a 510(k)
Top companies in PFO
| Company | 510(k)s | Recalls |
|---|---|---|
| Cochlear Americas | 5 | 0 |
| Med-El Elektromedizinische Geraete GmbH | 5 | 0 |
| Cochlear | 1 | 0 |
| Oticon Medical AB | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jul 10, 2026 | K260902 | Cochlear Osia® 3(I) Sound Processor;Cochlear Osia® 3 Sound Processor;Cochlear Osia® 3 Charger;Cochlear Osia® 3 Aqua+ Cochlear Americas | PFO |
| Jul 10, 2024 | K240614 | Sentio Ti Implant Kit; Sentio 1 Mini; Genie Medical BAHS Oticon Medical AB, SE | PFO |
| Apr 18, 2024 | K240155 | Cochlear Osia System Cochlear Americas | PFO |
| Aug 18, 2023 | K231204 | Cochlear Osia® System; Cochlear Osia® OSI300 Implant; Cochlear Magnet Cassette; Cochlear Non-Magnetic Cassette; Coch Cochlear | PFO |
| Jul 27, 2022 | K220922 | Cochlear Osia 2 System, Cochlear Osia OSI200 Implant, Cochlear Osia 2 Sound Processor, Cochlear Osia Fitting Software 2, Cochlear Americas | PFO |
| Oct 9, 2020 | K201983 | BCI 602 Lifts (1 mm), BCI Lifts (1 mm), BCI Lifts (2 mm & 3 mm), BCI Lifts (4 mm) Med-El Elektromedizinische Geraete GmbH, AT | PFO |
| Jul 29, 2020 | K200504 | BONEBRIDGE System, SAMBA 2 BB, SYMFIT 8.0, SAMBA 2 GO, SAMBA 2 Remote Med-El Elektromedizinische Geraete GmbH, AT | PFO |
| Nov 15, 2019 | K191921 | Cochlear Osia OSI200 Implant, Cochlear Osia 2 Sound Processor, Osia Fitting Software 2.0, Osia SmartApp, Cochlear Osia S Cochlear Americas | PFO |
| Sep 18, 2019 | K191457 | BONEBRIDGE System, Bone Conduction Implant Kit (BCI 602 Implant Kit), BCI 602 Sizer Kit, BCI 602 Lifts (1mm) Med-El Elektromedizinische Geraete GmbH, AT | PFO |
| Jul 3, 2019 | K190589 | Cochlear Osia OSI100 Implant, Cochlear Osia Sound Processor, Osia Intraoperative Test Software, Osia Fitting Software, C Cochlear Americas | PFO |
| Mar 7, 2019 | K183373 | Bonebridge Med-El Elektromedizinische Geraete GmbH, AT | PFO |
| Jul 20, 2018 | DEN170009 | Bonebridge Med-El Elektromedizinische Geraete GmbH, AT | PFO |
Free CSV: newest 100 rows. Paid plans export up to 1,000 or 10,000 rows.