Data / Medical devices / Israel / Novoxel Ltd.
Novoxel Ltd.: FDA-registered device maker in Netanya Tel Aviv, Israel, 3 510(k) clearances
Novoxel Ltd. is registered with the FDA (registration 3014193078) in Netanya Tel Aviv, Israel. It lists 3 device types. The FDA files 3 510(k) clearances under its listings, the newest dated November 4, 2024. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3014193078
- Address
- 43 Hamelaha Street, Netanya Tel Aviv, Israel, 4250573
- Owner or operator
- Novoxel Ltd. (10080890)
- Roles
- Manufacturer
- First device listed
- March 4, 2021
- Registered through
- 2026
- Brand names listed
- T2 Cart, TC Cart, Tixel C, Tixel I cart, Tixel System, Tixel i, Tixel® 2 System
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Cart, Emergency, Cardiopulmonary (Excluding Equipment) | BZN | 1 | Manufacturer | accessdata.fda.gov |
| Electrosurgical, Cutting & Coagulation & Accessories | GEI | 2 | Manufacturer | accessdata.fda.gov |
| Eyelid Thermal Pulsation System | ORZ | 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 |
|---|---|---|---|---|---|---|
| November 4, 2024 | K240512 | Tixel i (TXLI0001) | ORZ | Substantially Equivalent | Novoxel , Ltd. | accessdata.fda.gov |
| June 21, 2023 | K223033 | Tixel® 2 System | GEI | Substantially Equivalent | Novoxel , Ltd. | accessdata.fda.gov |
| February 25, 2021 | K202988 | Tixel System | GEI | Substantially Equivalent | Novoxel , Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Eyelid Thermal Pulsation System
- All makers of Cart, Emergency, Cardiopulmonary (Excluding Equipment)
- All makers of Electrosurgical, Cutting & Coagulation & Accessories
Updated November 4, 2024. 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.