Data / Medical devices / Israel / Uc-Care
Uc-Care: FDA-registered device maker in Yokneam Northern, Israel, 5 510(k) clearances
Uc-Care is registered with the FDA (registration 3009598843) in Yokneam Northern, Israel. It lists 3 device types. The FDA files 5 510(k) clearances under its listings, the newest dated July 30, 2026. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3009598843
- Address
- Apollo building, Yokneam Northern, Israel, 2069200
- Owner or operator
- UC-Care (10040672)
- Roles
- Manufacturer
- First device listed
- May 6, 2012
- Registered through
- 2026
- Brand names listed
- Navigo, Navigo Workstation, SmartBx, SmartGuide Disposable Needle Guides and Grids
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Applicator, Absorbent Tipped, Sterile | KXG | 1 | Manufacturer | accessdata.fda.gov |
| System, Image Processing, Radiological | LLZ | 2 | Manufacturer | accessdata.fda.gov |
| Transducer, Ultrasonic, Diagnostic | ITX | 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 |
|---|---|---|---|---|---|---|
| July 30, 2026 | K260161 | SmartGuide Disposable Guides and Grids | ITX | Substantially Equivalent | UC-CARE , Ltd. | accessdata.fda.gov |
| August 7, 2025 | K250664 | Navigo Workstation 2.3 (FPRMC00039) | LLZ | Substantially Equivalent | UC-CARE , Ltd. | accessdata.fda.gov |
| January 16, 2018 | K173054 | Navigo Workstation Version 2.0 | LLZ | Substantially Equivalent | UC-CARE , Ltd. | accessdata.fda.gov |
| February 6, 2017 | K160934 | UC-CARE NaviGo Workstation | LLZ | Substantially Equivalent | UC-CARE , Ltd. | accessdata.fda.gov |
| November 1, 2011 | K100784 | UC-CARE NAVIGO SYTEM | LLZ | Substantially Equivalent | UC-CARE , Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Applicator, Absorbent Tipped, Sterile
- All makers of System, Image Processing, Radiological
- All makers of Transducer, Ultrasonic, Diagnostic
Updated July 30, 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.