Not currently registered with FDA under this name
Biomedics
Los Angeles, CA, United States. Named as applicant on 6 dental 510(k) clearances between 1995 and 1999. No establishment is registered with FDA under this exact name today.
- Device types listed
- 0
- Brands and models
- 0
- 510(k) clearances
- 61995–1999
- Markets registered in
- 22 registrations outside the US
- Establishments
- 0—
510(k) clearances per year, 1990–2026
Registered in 2 markets
Where regulators' registries name Biomedics as the manufacturer or the registration holder of a device.
| Market | Regulator | Named as | Name on the registry | Registrations | Issued | Records |
|---|---|---|---|---|---|---|
| United States | FDA | Applicant | Biomedics | 6 clearances | 1995–1999 | Below |
| India | CDSCO | Registration holder | BIOMEDICS | 2 | 2024–2024 | Pure Global AI |
Outside the US the count is of all the company's device registrations in that market, dental or not · matched by company name and country · registry data read 12 Nov 2026
510(k) clearances
Clearances on which FDA names Biomedics as the applicant.
| Decided | 510(k) | Device | Device type |
|---|---|---|---|
| 23 Nov 1999 | K992330 | THE BIOPLATE RIGID FIXATION BONE PLATING SYSTEM FOR CRANIOMAXILLOFACIAL SURGERY | JEY Bone Plate |
| 9 Jun 1998 | K980983 | THE BIOPLATE RIGID FIXATION BONE PLATING SYSTEM FOR CRANIOMAXILLOFACIAL SURGERY | JEY Bone Plate |
| 25 Sep 1997 | K972463 | THE BIOPLATE RIGID FIXATION BONE PLATING SYSTEM FOR CRANIOMAXILLOFACIAL SURGERY | JEY Bone Plate |
| 16 Aug 1996 | K961976 | THE BIOPLATE FIXATION SYSTEM | JEY Bone Plate |
| 29 Sep 1995 | K953273 | BIOPLATE RIGID FIXATION BONE PLATING SYSTEM | JEY Bone Plate |
| 6 Jan 1995 | K943071 | THE TITANIUM FIXATION SYSTEM | JEY Bone Plate |
Some of these clearances are listed with FDA today by another company: Bioplate, Inc. (5).
Sources
FDA 510(k) premarket notification file. FDA data as of 2 Nov 2026; snapshot 12 Nov 2026. The location shown is the address on FDA's record of the most recent filing, which can be a US agent.