Recognized a 510(k)/PMA number — showing its clearance record and devices.
Devices
| Brand | Model | Company | Product codes | Primary DI |
|---|---|---|---|---|
| DIO Biotite-H Implant System | SFN 3810H | DIO Corporation | DZE | 08806195922002 |
| DIO Biotite-H Implant System | SFN 3814H | DIO Corporation | DZE | 08806195922026 |
| DIO Biotite-H Implant System | SFN 3808H | DIO Corporation | DZE | 08806195921999 |
| DIO Biotite-H Implant System | SFR 4510H | DIO Corporation | DZE | 08806195922088 |
| DIO Biotite-H Implant System | SFW 5308H | DIO Corporation | DZE | 08806195922118 |
| DIO Biotite-H Implant System | SFN 4112H | DIO Corporation | DZE | 08806195922057 |
| DIO Biotite-H Implant System | SFN 4108H | DIO Corporation | DZE | 08806195922033 |
| DIO Biotite-H Implant System | SFW 5310H | DIO Corporation | DZE | 08806195922125 |
| DIO Biotite-H Implant System | SFR 4512H | DIO Corporation | DZE | 08806195922095 |
| DIO Biotite-H Implant System | SFW 5314H | DIO Corporation | DZE | 08806195922149 |
| DIO Biotite-H Implant System | SFR 4514H | DIO Corporation | DZE | 08806195922101 |
| DIO Biotite-H Implant System | SFR 4508H | DIO Corporation | DZE | 08806195922071 |
| DIO Biotite-H Implant System | SFW 5312H | DIO Corporation | DZE | 08806195922132 |
| DIO Biotite-H Implant System | SFN 3812H | DIO Corporation | DZE | 08806195922019 |
| DIO Biotite-H Implant System | SFN 4110H | DIO Corporation | DZE | 08806195922040 |
| DIO Biotite-H Implant System | SFN 4114H | DIO Corporation | DZE | 08806195922064 |