Data / Medical devices / Israel / Ots-Medical
Ots-Medical: FDA-registered device maker in Binyamina Haifa, Israel, 3 510(k) clearances
Ots-Medical is registered with the FDA (registration 3038185071) in Binyamina Haifa, Israel. It lists 1 device type. The FDA files 3 510(k) clearances under its listings, the newest dated July 22, 2025. Registered through 2027. FDA data exported November 2, 2026.
SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.
- FDA registration number
- 3038185071
- Address
- 3 Hamelacha st, Binyamina Haifa, Israel, 3057324
- Owner or operator
- OTS-Medical (10093227)
- Roles
- Specification developer
- First device listed
- April 15, 2025
- Registered through
- 2027
- Brand names listed
- OTS 25, OTS 25 L, Raphael 25
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Fastener, Fixation, Nondegradable, Soft Tissue | MBI | 2 | Specification developer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| July 22, 2025 | K251310 | OTS 25-L (100-5) | MBI | Substantially Equivalent | Ots Medical , Ltd. | accessdata.fda.gov |
| January 23, 2025 | K241234 | OTS 25-L (100-5) | MBI | Substantially Equivalent | Ots Medical , Ltd. | accessdata.fda.gov |
| December 7, 2023 | K233429 | OTS 25 (100-1) | MBI | Substantially Equivalent | Ots Medical , Ltd. | accessdata.fda.gov |
Compare with other makers
Updated July 22, 2025. 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.