Registered with FDA
Marina Medical Instruments
Davie, FL, United States. Lists 2 dental device types with FDA across 1 registered establishment.
- Device types listed
- 2
- Brands and models
- 2
- 510(k) clearances
- 0as applicant
- Markets registered in
- 8717 registrations outside the US
- Establishments
- 1United States
Registered in 8 markets
Where regulators' registries name Marina Medical Instruments 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 | Marina Medical Instruments | 2 device types | — | Below |
| Thailand | Thai FDA | Manufacturer | MARINA MEDICAL INSTRUMENTS, INC.MARINA MEDICAL INSTRUMENTS, INC | 663 | — | Pure Global AI |
| Brazil | ANVISA | Manufacturer | Marina Medical Instruments, Inc.MARINA MEDICAL INSTRUMENTS INC. · MARINA MEDICAL INSTRUMENTS, INC. | 18 | 2011–2026 | Pure Global AI |
| Colombia | INVIMA | Registration holder | MARINA MEDICAL INSTRUMENTS S.A.S.MARINA MEDICAL INSTRUMENTS SAS · MARINA MEDICAL INSTRUMENTS INC | 17 | — | Pure Global AI |
| Australia | TGA | Manufacturer | Marina Medical Instruments Inc | 7 | 2017–2026 | Pure Global AI |
| Taiwan | TFDA | Manufacturer | MARINA MEDICAL INSTRUMENTS, INC.MARINA MEDICAL INSTRUMENTS · MARINA MEDICAL INSTRUMENTS, INC | 7 | 2007–2016 | Pure Global AI |
| Israel | AMAR | Manufacturer | Marina Medical Instruments, Inc.Marina Medical Instruments Inc | 4 | — | Pure Global AI |
| South Korea | MFDS | Manufacturer | MARINA MEDICAL INSTRUMENTS,Inc. | 1 | 2014–2014 | 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 Marina Medical Instruments 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 Plastic Filling InstrumentEIY · Class 1 | Dental hand instruments | Lister | Trocar, Pyramidal | 2019 |
| Surgical Bone FileEMI · Class 1 | Dental hand instruments | Lister | Sharpener | 2024 |
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 |
|---|---|---|
| MARINA MEDICAL INSTRUMENTS, INC.FDA reg. 2084346 | Davie, FL, United States | Repacker / relabeler |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 9001093). 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.