Registered with FDA
ZIMMER GmbH
Zug, Switzerland. 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
- 7121 registrations outside the US
- Establishments
- 1Netherlands
Registered in 7 markets
Where regulators' registries name ZIMMER GmbH as the manufacturer or the registration holder of a device.
| Market | Regulator | Named as | Name on the registry | Registrations | Issued | Records |
|---|---|---|---|---|---|---|
| United States | FDA | Lister | ZIMMER GmbH | 1 device types | — | Below |
| Colombia | INVIMA | Manufacturer | ZIMMER GMBH | 59 | — | Pure Global AI |
| Taiwan | TFDA | Manufacturer | ZIMMER GMBH | 29 | 2006–2025 | Pure Global AI |
| Brazil | ANVISA | Manufacturer | ZIMMER GMBH | 19 | 2008–2020 | Pure Global AI |
| Israel | AMAR | Manufacturer | Zimmer GmbHZIMMER GmbH | 10 | — | Pure Global AI |
| Peru | DIGEMID | Manufacturer | ZIMMER GmbH | 3 | 2021–2025 | Pure Global AI |
| Saudi Arabia | SFDA | Manufacturer | Biomet Global Supply Chain Center | 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 ZIMMER GmbH 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 | Lister | ENDOBON XENOGRAFT GRANULES | 2020 |
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
ZIMMER GmbH 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: Biomet 3i, LLC (1).
| Decided | 510(k) | Device | Applicant | Device type |
|---|---|---|---|---|
| 13 May 2011 | K110449 | ENDOBON XENOGRAFT GRANULES | Biomet 3i, LLC | LYC Synthetic Bone Grafting Material |
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| Biomet Global Supply Chain Center B.V.FDA reg. 3013055499 | Hazeldonk Noord-Brabant, Netherlands | Foreign exporter |
Other names on FDA records
Biomet Global Supply Chain Center
Sources
FDA establishment registration & device listing (search FDA, owner/operator 9064978). 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.