Data / Medical devices / Israel / Medi-Tate
Medi-Tate: FDA-registered device maker in Hadera Northern, Israel, 2 510(k) clearances
Medi-Tate is registered with the FDA (registration 3016677053) in Hadera Northern, Israel. It lists 1 device type. The FDA files 2 510(k) clearances under its listings, the newest dated June 25, 2021. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3016677053
- Address
- 17 Hauman Street, Hadera Northern, Israel, 3850169
- Owner or operator
- Medi-Tate (10063028)
- Roles
- Manufacturer
- First device listed
- March 15, 2020
- Registered through
- 2026
- Brand names listed
- iTind, iTind Removal Kit
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Temporarily-Placed Urethral Opening System For Symptoms Of Benign Prostatic Hyperplasia | QKA | 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 |
|---|---|---|---|---|---|---|
| June 25, 2021 | K210138 | iTind System | QKA | Substantially Equivalent | Medi-Tate , Ltd. | accessdata.fda.gov |
| February 25, 2020 | DEN190020 | iTind System | QKA | Unknown | Medi-Tate , Ltd. | accessdata.fda.gov |
Compare with other makers
Updated June 25, 2021. 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.