Manufacturer registered with FDA
Bayer Medical Care Inc.
Indianola, PA, United States. Lists 1 dental device type with FDA across 1 registered establishment.
- Device types listed
- 1
- Brands and models
- 1
- 510(k) clearances
- 0as applicant
- Markets registered in
- 15382 registrations outside the US
- Establishments
- 1United States
Registered in 15 markets
Where regulators' registries name Bayer Medical Care Inc. as the manufacturer or the registration holder of a device.
| Market | Regulator | Named as | Name on the registry | Registrations | Issued | Records |
|---|---|---|---|---|---|---|
| United States | FDA | Manufacturer | Bayer Medical Care Inc. | 1 device types | — | Below |
| Colombia | INVIMA | Registration holder | BAYER MEDICAL CARE INC | 77 | — | Pure Global AI |
| Serbia | ALIMS | Manufacturer | Bayer Medical Care Inc. | 42 | 2022–2026 | Pure Global AI |
| Taiwan | TFDA | Manufacturer | Bayer Medical Care Inc.Bayer Medical Care Inc · BAYER MEDICAL CARE INC. | 36 | 1997–2026 | Pure Global AI |
| Costa Rica | Ministerio de Salud | Manufacturer | Bayer Medical Care Inc. | 31 | — | Pure Global AI |
| South Korea | MFDS | Manufacturer | Bayer Medical Care Inc.Bayer Medical Care Inc | 28 | 1999–2026 | Pure Global AI |
| United Kingdom | MHRA | Manufacturer | Bayer Medical Care Inc. | 28 | — | Pure Global AI |
| European Union | EUDAMED | Manufacturer | Bayer Medical Care Inc. | 26 | — | Pure Global AI |
| Peru | DIGEMID | Manufacturer | BAYER MEDICAL CARE INC. | 26 | 2012–2026 | Pure Global AI |
| Brazil | ANVISA | Manufacturer | BAYER MEDICAL CARE INCORPORATEDBAYER MEDICAL CARE INC. · Bayer Medical Care Inc | 22 | 2015–2024 | Pure Global AI |
| China | NMPA | Registration holder | 拜耳医疗保健公司Bayer Medical Care Inc.拜耳医疗保健公司Bayer Medical Care,Inc. · 拜耳医疗保健公司 Bayer Medical Care Inc. · +2 | 21 | — | Pure Global AI |
| Australia | TGA | Manufacturer | Bayer Medical Care Inc | 17 | 2003–2024 | Pure Global AI |
| Saudi Arabia | SFDA | Manufacturer | Bayer Medical Care Inc. | 16 | — | Pure Global AI |
| Hong Kong | MDD | Manufacturer | Bayer Medical Care Inc. | 6 | 2015–2026 | Pure Global AI |
| Israel | AMAR | Manufacturer | Bayer Medical Care Inc.Bayer Medical Care Inc | 6 | — | 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
Devices listed with FDA
What Bayer Medical Care Inc. currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| CephalometerEAG · Class 2 | — | Maker | Burnett TMJ Appliance | 2008 |
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026
Also lists devices cleared under other names
Bayer Medical Care Inc. lists these devices with FDA today. The clearance names a different applicant, as happens after a rename, an acquisition or a private-label agreement.
Original applicants: Medrad, Inc. (1).
| Decided | 510(k) | Device | Applicant | Device type |
|---|---|---|---|---|
| 24 Feb 1987 | K870243 | BURNETT TMJ APPLIANCE | Medrad, Inc. | EAG Cephalometer |
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| Bayer Medical Care Inc.FDA reg. 2520313 | INDIANOLA, PA, United States | Complaint file establishment, Specification developer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 2520313). 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.