Registered with FDA
HNM Medical
Miami, FL, United States. Lists 5 dental device types with FDA across 1 registered establishment.
- Device types listed
- 5
- Brands and models
- 5
- 510(k) clearances
- 0as applicant
- Markets registered in
- 520 registrations outside the US
- Establishments
- 1United States
Registered in 5 markets
Where regulators' registries name HNM Medical 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 | HNM Medical | 5 device types | — | Below |
| Colombia | INVIMA | Registration holder | HNM MEDICAL | 9 | — | Pure Global AI |
| South Korea | MFDS | Manufacturer | HNM Medical | 9 | 2013–2014 | Pure Global AI |
| Costa Rica | Ministerio de Salud | Manufacturer | HNM Medical | 1 | — | Pure Global AI |
| Israel | AMAR | Manufacturer | HNM Medical | 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 HNM Medical 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 Dressing ForcepsEFL · Class 1 | Dental hand instruments | Lister | HNM Medical Surgical Instrument | 2018 |
| All Types RetractorEIG · Class 1 | Dental hand instruments | Lister | HNM Medical Surgical Instrument | 2018 |
| Operative ExplorerEKB · Class 1 | Dental hand instruments | Lister | HNM Medical Surgical Instrument | 2018 |
| Operative Dental ExcavatorEKC · Class 1 | Dental hand instruments | Lister | HNM Medical Surgical Instrument | 2018 |
| Surgical Tooth Extractor ForcepsEMG · Class 1 | Dental hand instruments | Lister | HNM Medical Surgical Instrument | 2018 |
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 |
|---|---|---|
| HNM Medical dba HNM TOTAL RECONFDA reg. 3009513193 | Miami, FL, United States | Complaint file establishment, Repacker / relabeler |
Other names on FDA records
HNM Medical dba HNM TOTAL RECON
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10049219). 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.