Not currently registered with FDA under this name
Abiomed, Inc.
Danvers, MA, United States. Named as applicant on 2 dental 510(k) clearances between 1989 and 1991. No establishment is registered with FDA under this exact name today.
- Device types listed
- 0
- Brands and models
- 0
- 510(k) clearances
- 21989–1991
- Markets registered in
- 15156 registrations outside the US
- Establishments
- 0—
510(k) clearances per year, 1980–2026
Registered in 15 markets
Where regulators' registries name Abiomed, Inc. as the manufacturer or the registration holder of a device.
RegisteredHome: United StatesOne marker per market
| Market | Regulator | Named as | Name on the registry | Registrations | Issued | Records |
|---|---|---|---|---|---|---|
| United States | FDA | Applicant | Abiomed, Inc. | 2 clearances | 1989–1991 | Below |
| Canada | Health Canada | Registration holder | ABIOMED INC. | 59 | 2002–2024 | Pure Global AI |
| Saudi Arabia | SFDA | Manufacturer | Abiomed Inc. | 24 | — | Pure Global AI |
| Australia | TGA | Manufacturer | Abiomed Inc | 16 | 2017–2026 | Pure Global AI |
| European Union | EUDAMED | Registration holder | Abiomed Inc.Abiomed, Inc. | 16 | — | Pure Global AI |
| United Kingdom | MHRA | Manufacturer | Abiomed, Inc. | 13 | — | Pure Global AI |
| Hong Kong | MDD | Manufacturer | Abiomed, Inc.Abiomed Inc. · Abiomed, Inc | 6 | 2022–2026 | Pure Global AI |
| Serbia | ALIMS | Manufacturer | Abiomed, Inc. | 5 | 2024–2025 | Pure Global AI |
| Taiwan | TFDA | Manufacturer | Abiomed Inc. | 5 | 2020–2021 | Pure Global AI |
| Brazil | ANVISA | Manufacturer | ABIOMED, INCABIOMED, INC. | 4 | 2008–2008 | Pure Global AI |
| Costa Rica | Ministerio de Salud | Manufacturer | ABIOMED, INC. | 2 | — | Pure Global AI |
| Israel | AMAR | Manufacturer | Abiomed Inc. | 2 | — | Pure Global AI |
| Peru | DIGEMID | Manufacturer | ABIOMED, INC | 2 | 2023–2023 | Pure Global AI |
| China | NMPA | Registration holder | 阿比奥梅德公司Abiomed, Inc. | 1 | — | Pure Global AI |
| Colombia | INVIMA | Manufacturer | ABIOMED INC. | 1 | — | 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
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.