Manufacturer registered with FDA
Acumed LLC
Hillsboro, OR, United States. Lists 2 dental device types with FDA across 1 registered establishment.
- Device types listed
- 2
- Brands and models
- 0
- 510(k) clearances
- 0as applicant
- Markets registered in
- 151,137 registrations outside the US
- Establishments
- 1United States
Registered in 15 markets
Where regulators' registries name Acumed LLC 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 | Acumed LLC | 2 device types | — | Below |
| Canada | Health Canada | Registration holder | ACUMED, LLC | 530 | 1999–2026 | Pure Global AI |
| United Kingdom | MHRA | Manufacturer | Acumed LLC | 152 | — | Pure Global AI |
| Saudi Arabia | SFDA | Manufacturer | Acumed LLC | 129 | — | Pure Global AI |
| Costa Rica | Ministerio de Salud | Manufacturer | Acumed LLCACUMED LLC | 104 | — | Pure Global AI |
| Peru | DIGEMID | Manufacturer | ACUMED LLC | 46 | 2015–2026 | Pure Global AI |
| South Korea | MFDS | Manufacturer | Acumed LLCAcumed Inc. · Acumed LLC. · +1 | 46 | 1999–2022 | Pure Global AI |
| Australia | TGA | Manufacturer | Acumed LLC | 35 | 2004–2026 | Pure Global AI |
| Brazil | ANVISA | Manufacturer | ACUMED LLCACUMED INC · ACUMED LLC. | 33 | 2006–2026 | Pure Global AI |
| Taiwan | TFDA | Manufacturer | ACUMED LLC.Acumed LLC. | 32 | 2008–2026 | Pure Global AI |
| Colombia | INVIMA | Manufacturer | ACUMED LLC | 8 | — | Pure Global AI |
| China | NMPA | Registration holder | 艾克曼有限公司Acumed LLC | 7 | — | Pure Global AI |
| European Union | EUDAMED | Manufacturer | Acumed LLC | 7 | — | Pure Global AI |
| Hong Kong | MDD | Manufacturer | Acumed LLC | 7 | 2017–2026 | Pure Global AI |
| Israel | AMAR | Manufacturer | Acumed LLC | 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
Devices listed with FDA
What Acumed LLC currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Manual Wire Driver and Bone DrillDZJ · Class 2 | Surgical drills & motors | Maker | — | 2026 |
| Bone PlateJEY · Class 2 | Maxillofacial plates & screws | Maker | — | 2026 |
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
Acumed LLC 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: Techfit Digital Surgery, Inc. (2), Industrias Medicas Sampedro S.A.S (1).
| Decided | 510(k) | Device | Applicant | Device type |
|---|---|---|---|---|
| 11 Dec 2024 | K242263 | TECHFIT DISRP® System | Techfit Digital Surgery, Inc. | DZJ Manual Wire Driver and Bone Drill |
| 23 Jun 2023 | K230276 | TECHFIT DISRP® System | Techfit Digital Surgery, Inc. | DZJ Manual Wire Driver and Bone Drill |
| 19 May 2021 | K203282 | TECHFIT Patient-Specific Maxillofacial System | Industrias Medicas Sampedro S.A.S | JEY Bone Plate |
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| ACUMED LLCFDA reg. 3025141 | Hillsboro, OR, United States | Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 9001805). 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.