Manufacturer registered with FDA
Medi-Dyne Healthcare Products, Ltd.
Colleyville, TX, United States. Lists 1 dental device type with FDA across 1 registered establishment.
- Device types listed
- 1
- Brands and models
- 7
- 510(k) clearances
- 0as applicant
- Markets registered in
- 33 registrations outside the US
- Establishments
- 1United States
Registered in 3 markets
Where regulators' registries name Medi-Dyne Healthcare Products, Ltd. as the manufacturer or the registration holder of a device.
| Market | Regulator | Named as | Name on the registry | Registrations | Issued | Records |
|---|---|---|---|---|---|---|
| United States | FDA | Manufacturer | Medi-Dyne Healthcare Products, Ltd. | 1 device types | — | Below |
| Colombia | INVIMA | Manufacturer | MEDI-DYNE HEALTHCARE PRODUCTS, INC. | 2 | — | Pure Global AI |
| Israel | AMAR | Manufacturer | MEDI-DYNE HEALTHCARE PRODUCTS | 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 Medi-Dyne Healthcare Products, Ltd. currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Patient Personal Hygiene KitNSB · Class 1 | — | Maker | 2 Toms Butt ShieldTT012p2 Toms Foot Shield - TT240P2 Toms Grip Shield - TT210p2 Toms Sport Shield XTRA - TT067P2 Toms Sports Shield - TT005P2 Toms Stink Free Detergent and Spray - TT400 & TT4052Toms Blister Shield - TT003P & TT004 | 2014 |
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 |
|---|---|---|
| MEDI-DYNE HEALTHCARE PRODUCTS, INC.FDA reg. 3003175285 | COLLEYVILLE, TX, United States | Specification developer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 9054275). 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.