Data / Medical devices / Turkey / Occlutech Tibbi Urunler San.ve Tic. Ltd. Sti
Occlutech Tibbi Urunler San.ve Tic. Ltd. Sti: FDA-registered device maker in Bakirkoy Istanbul, Turkey, 1 PMA approval
Occlutech Tibbi Urunler San.ve Tic. Ltd. Sti is registered with the FDA (registration 3012290852) in Bakirkoy Istanbul, Turkey. It lists 1 device type. The FDA files 1 PMA approval under its listings, the newest dated December 29, 2023. Registered through 2026. FDA data exported November 3, 2026.
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- FDA registration number
- 3012290852
- Address
- Yesilkoy SB Mah, E Blok Sok, Occlutech Apt. No:6, Bakirkoy Istanbul, Turkey, 34149
- Owner or operator
- Occlutech Holding AG (10084004)
- Roles
- Manufacturer
- First device listed
- January 17, 2024
- Registered through
- 2026
- Brand names listed
- Occlutech ASD Occluder and Occlutech Pistol Pusher
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Transcatheter Septal Occluder (Atrial) | OZG | 3 | Manufacturer | accessdata.fda.gov |
PMA approvals
Premarket approvals this establishment lists, with the supplements the FDA has decided since.
| Approved | PMA number | Device | Product code | Supplements | Latest decision | Source |
|---|---|---|---|---|---|---|
| December 29, 2023 | P200032 | Occlutech® ASD Occluder and Occlutech® Pistol Pusher | OZG | 6 | June 5, 2026 | accessdata.fda.gov |
Compare with other makers
Updated June 5, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.