Registered with FDA
Elmed, Inc.
Glendale Heights, IL, United States. Lists 5 dental device types with FDA across 1 registered establishment.
- Device types listed
- 5
- Brands and models
- 4
- 510(k) clearances
- 0as applicant
- Markets registered in
- 411 registrations outside the US
- Establishments
- 1United States
Registered in 4 markets
Where regulators' registries name Elmed, Inc. 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 | Elmed, Inc. | 5 device types | — | Below |
| Taiwan | TFDA | Manufacturer | ELMED-INCORPORATEDELMED INCORPORATED | 6 | 2006–2020 | Pure Global AI |
| Colombia | INVIMA | Registration holder | ELMED SAS | 3 | — | Pure Global AI |
| South Korea | MFDS | Manufacturer | ELMED INCORPORATED | 2 | 1999–2001 | 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 Elmed, Inc. currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Dental Hand InstrumentsDZN · Class 1 | Dental hand instruments | Lister | — | 2023 |
| Surgical HemostatEMD · Class 1 | Dental hand instruments | Lister | ELMED | 1992 |
| Surgical Biopsy PunchEME · Class 1 | Dental hand instruments | Lister | ELMED | 1992 |
| Surgical Rongeur ForcepsEMH · Class 1 | Dental hand instruments | Lister | ELMED | 1992 |
| Surgical Bone ChiselEML · Class 1 | Dental hand instruments | Lister | ELMED | 1992 |
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| ELMED, INC.FDA reg. 1412854 | Glendale Heights, IL, United States | Repacker / relabeler |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 1412854). 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.