Registered with FDA
Jedmed Instrument Co.
Saint Louis, MO, United States. Lists 7 dental device types with FDA across 1 registered establishment, and holds 4 510(k) clearances as applicant.
- Device types listed
- 7
- Brands and models
- 7
- 510(k) clearances
- 41981–1981
- Markets registered in
- 676 registrations outside the US
- Establishments
- 1United States
510(k) clearances per year, 1980–2026
Registered in 6 markets
Where regulators' registries name Jedmed Instrument Co. 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 | Jedmed Instrument Co. | 4 clearances | 1981–1981 | Below |
| Canada | Health Canada | Registration holder | JEDMED INSTRUMENT COMPANY | 56 | 2001–2007 | Pure Global AI |
| Costa Rica | Ministerio de Salud | Manufacturer | JEDMED Instrument CompanyJEDMED INSTRUMENT CO. | 17 | — | Pure Global AI |
| Israel | AMAR | Manufacturer | JEDMED INSTRUMENT COMPANY | 1 | — | Pure Global AI |
| South Korea | MFDS | Manufacturer | JEDMED INSTRUMENT COMPANY | 1 | 2007–2007 | Pure Global AI |
| Taiwan | TFDA | Manufacturer | JEDMED INSTRUMENT COMPANY | 1 | 2007–2007 | 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 Jedmed Instrument Co. currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Mouth MirrorEAX · Class 1 | Dental hand instruments | Lister | MIRROR MICRO RNODIUM | 2000 |
| Irrigating (Dental) SyringeEIB · Class 1 | Dental hand instruments | Lister | JEDMED | 2007 |
| Dental Retractor AccessoriesEIF · Class 1 | Dental hand instruments | Lister | RUBINSTEIN RETRACTOR | 2000 |
| Operative BurnisherEKJ · Class 1 | Dental hand instruments | Lister | BALL BURNISHER | 2000 |
| Endodontic Root Canal PluggerEKR · Class 1 | Dental hand instruments | Lister | PLUGGERRUBENSTEIN | 2000 |
| Dental Surgical CuretteEMK · Class 1 | Dental hand instruments | Lister | — | 2016 |
| Surgical Osteotome ChiselEMM · Class 1 | Dental hand instruments | Lister | Osteotome Chisel | 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 Jedmed Instrument Co. as the applicant.
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| JEDMED Instrument CompanyFDA reg. 1926681 | Saint Louis, MO, United States | Repacker / relabeler |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 1926681). 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.