Registered with FDA
Sanmed Medikal Otomotiv Tekstil Ticaret Limited Sirketi
Istanbul, Türkiye. Lists 3 dental device types with FDA across 1 registered establishment.
- Device types listed
- 3
- Brands and models
- 3
- 510(k) clearances
- 0as applicant
- Markets registered in
- 1United States
- Establishments
- 1Türkiye
Devices listed with FDA
What Sanmed Medikal Otomotiv Tekstil Ticaret Limited Sirketi currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Powered Bone DrillDZI · Class 2 | Surgical drills & motors | Lister | STRYKER TOTAL PERFORMANCE (TPS) SYSTEM | 2024 |
| Manual Wire Driver and Bone DrillDZJ · Class 2 | Surgical drills & motors | Lister | BURR | 2024 |
| Operative Dental UnitEIA · Class 1 | Dental chairs & operative units | Lister | STRYKER TOTAL PERFORMANCE (TPS) SYSTEM | 2024 |
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026
Also lists devices cleared under other names
Sanmed Medikal Otomotiv Tekstil Ticaret Limited Sirketi lists these devices with FDA today. The clearance names a different applicant, as happens after a rename, an acquisition or a private-label agreement.
Original applicants: Stryker (2).
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| SANMED MEDIKAL OTOMOTIV TEKSTIL TICARET LIMITED SIRKETIFDA reg. 3014479313 | Istanbul, Türkiye | Foreign exporter |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10089530). 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.