Data / Medical devices / Israel / ENTIRE MEDICAL Ltd
ENTIRE MEDICAL Ltd: FDA-registered device maker in HERZLIYA Central, Israel, 2 510(k) clearances
ENTIRE MEDICAL Ltd is registered with the FDA (registration 3043585137) in HERZLIYA Central, Israel. It lists 1 device type. The FDA files 2 510(k) clearances under its listings, the newest dated May 29, 2026. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3043585137
- Address
- Hahoshlim 11, HERZLIYA Central, Israel, 4672411
- Owner or operator
- ENTire Medical (10095112)
- Roles
- Manufacturer
- First device listed
- January 26, 2026
- Registered through
- 2026
- Brand names listed
- ENTire IRE System
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Electrosurgical, Cutting & Coagulation & Accessories | GEI | 2 | Manufacturer | 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 |
|---|---|---|---|---|---|---|
| May 29, 2026 | K261202 | ENTire IRE System | GEI | Substantially Equivalent | Entire Medical , Ltd. | accessdata.fda.gov |
| January 14, 2026 | K251996 | ENTire IRE System | GEI | Substantially Equivalent | Entire Medical , Ltd. | accessdata.fda.gov |
Compare with other makers
Updated May 29, 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.