Manufacturer registered with FDA
Baxter Healthcare Corp
Deerfield, IL, United States. Lists 1 dental device type with FDA across 2 registered establishments, and holds 4 510(k) clearances as applicant.
- Device types listed
- 1
- Brands and models
- 1
- 510(k) clearances
- 41988–2009
- Markets registered in
- 12165 registrations outside the US
- Establishments
- 2United Kingdom, United States
510(k) clearances per year, 1980–2026
Registered in 12 markets
Where regulators' registries name Baxter Healthcare Corp 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 | Baxter Healthcare Corp | 4 clearances | 1988–2009 | Below |
| Taiwan | TFDA | Manufacturer | BAXTER HEALTHCARE CORPORATIONBaxter Healthcare Corporation · Apatech Ltd. | 90 | 1976–2023 | Pure Global AI |
| Colombia | INVIMA | Manufacturer | BAXTER HEALTHCARE CORPORATIONAPATECH LTD | 27 | — | Pure Global AI |
| Brazil | ANVISA | Manufacturer | BAXTER HEALTHCARE CORPORATION | 15 | 1996–2025 | Pure Global AI |
| Canada | Health Canada | Registration holder | APATECH LIMITED | 10 | 2006–2013 | Pure Global AI |
| Australia | TGA | Manufacturer | Apatech Limited | 6 | 2011–2023 | Pure Global AI |
| United Kingdom | MHRA | Manufacturer | ApaTech Ltd | 5 | — | Pure Global AI |
| Israel | AMAR | Manufacturer | Baxter Healthcare Corporation | 4 | — | Pure Global AI |
| South Korea | MFDS | Manufacturer | Apatech Ltd. | 3 | 2008–2013 | Pure Global AI |
| Hong Kong | MDD | Manufacturer | Apatech LimitedApatech Ltd | 2 | 2023–2024 | Pure Global AI |
| Peru | DIGEMID | Manufacturer | BAXTER HEALTHCARE CORPORATION | 2 | 2014–2020 | Pure Global AI |
| European Union | EUDAMED | Manufacturer | Apatech Limited | 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 Baxter Healthcare Corp currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Synthetic Bone Grafting MaterialLYC · Class 2 | Bone grafts & membranes | Maker | Actifuse | 2015 |
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026
510(k) clearances
Clearances on which FDA names Baxter Healthcare Corp as the applicant, including filings under its other names.
| Decided | 510(k) | Device | Device type |
|---|---|---|---|
| 30 Jul 2009 | K090850 | ACTIFUSE BONE GRAFT SUBSTITUTE, ACTIFUSE MICROGRANULES BONE GRAFT SUBSTITUTE | LYC Synthetic Bone Grafting Material |
| 6 Aug 2008 | K081721 | TRICOS A RESORBABLE SUBSTITUTE | LYC Synthetic Bone Grafting Material |
| 8 Apr 2008 | K073571 | TRICOS T RESORBABLE BONE SUBSTITUTE | LYC Synthetic Bone Grafting Material |
| 2 Mar 1988 | K880590 | DISPOSABLE DENTAL PROBE/EXPLORER | EKJ Operative Burnisher |
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| APATECH LTD.FDA reg. 3004450973 | ELSTREE Hertfordshire, United Kingdom | Manufacturer |
| BAXTER HEALTHCARE CORPORATIONFDA reg. 1416980 | ROUND LAKE, IL, United States | Complaint file establishment |
Other names on FDA records
ApaTech Ltd
Sources
FDA establishment registration & device listing (search FDA, owner/operator 1417572). 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.