Data / Medical devices / Israel / Cartiheal Ltd.
Cartiheal Ltd.: FDA-registered device maker in Kfar Saba Central, Israel, 1 PMA approval
Cartiheal Ltd. is registered with the FDA (registration 3013881076) in Kfar Saba Central, Israel. It lists 2 device types. The FDA files 1 PMA approval under its listings, the newest dated March 29, 2022. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3013881076
- Address
- 17 Atir Yeda Street, Kfar Saba Central, Israel, 4464313
- Owner or operator
- Smith & Nephew, Inc. (1020279)
- Roles
- Manufacturer, Repackager or relabeler
- First device listed
- February 16, 2024
- Registered through
- 2026
- Brand names listed
- Agili-C, Agili-C Mini Disposable Toolset; Agili-C Surgical Toolset
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Implant, Resorbable, For Articular Osteochondral Repair | QRU | 3 | Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Instruments Designed For Press-Fit Osteochondral Implants | QBO | 2 | Manufacturer, Repackager or relabeler | 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 |
|---|---|---|---|---|---|---|
| March 29, 2022 | P210034 | Agili-C | QRU | 1 | June 4, 2026 | accessdata.fda.gov |
Compare with other makers
Updated June 4, 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.