Manufacturer registered with FDA
Aesculap AG
Tuttlingen, Germany. Lists 51 dental device types with FDA across 2 registered establishments.
- Device types listed
- 51
- Brands and models
- 51
- 510(k) clearances
- 0as applicant
- Markets registered in
- 92,467 registrations outside the US
- Establishments
- 2China, Germany
Registered in 9 markets
Where regulators' registries name Aesculap AG 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 | Aesculap AG | 51 device types | — | Below |
| Peru | DIGEMID | Manufacturer | AESCULAP AGAESCULAP | 999 | 2007–2026 | Pure Global AI |
| European Union | EUDAMED | Registration holder | Aesculap AG | 823 | — | Pure Global AI |
| Brazil | ANVISA | Manufacturer | AESCULAP AG | 218 | 1994–2026 | Pure Global AI |
| Taiwan | TFDA | Manufacturer | AESCULAP AGAesculap AG | 122 | 1990–2024 | Pure Global AI |
| Colombia | INVIMA | Manufacturer | AESCULAP AGAESCULAP AG. · B. BRAUN MEDICAL (SUZHOU) CO. LTD · +2 | 121 | — | Pure Global AI |
| China | NMPA | Registration holder | 蛇牌股份有限公司Aesculap AG蛇牌股份有限公司AESCULAP AG · 蛇牌股份有限公司 Aesculap AG · +1 | 85 | — | Pure Global AI |
| South Korea | MFDS | Manufacturer | B.Braun Medical (Suzhou) Co. LtdB.Braun Medical (Suzhou) Co., Ltd. · B. Braun Medical(Suzhou) Co., Ltd. · +2 | 76 | 1999–2024 | Pure Global AI |
| Israel | AMAR | Manufacturer | Aesculap AGAESCULAP AG · AESCULAP | 23 | — | 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 Aesculap AG currently lists, by FDA device type, with the brand and model names on the listing.
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
Aesculap AG 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: Aesculap, Inc. (1).
| Decided | 510(k) | Device | Applicant | Device type |
|---|---|---|---|---|
| 7 Apr 2006 | K060492 | AESCULAP CRANIOFACIAL PLATE AND SCREW | Aesculap, Inc. | JEY Bone Plate |
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| AESCULAP AGFDA reg. 9610612 | TUTTLINGEN, DONAU Baden-Wurttemberg, Germany | Complaint file establishment, Manufacturer |
| B.Braun Medical (Suzhou) Co,.LtdFDA reg. 3008711893 | Suzhou Jiangsu, China | Contract manufacturer |
Other names on FDA records
B.Braun Medical (Suzhou)Co.Ltd
Sources
FDA establishment registration & device listing (search FDA, owner/operator 8010193). 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.