Data / Medical devices / Israel / Bioprotect Ltd.
Bioprotect Ltd.: FDA-registered device maker in Netanya Central, Israel, 1 510(k) clearance
Bioprotect Ltd. is registered with the FDA (registration 3014285231) in Netanya Central, Israel. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated August 25, 2023. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3014285231
- Address
- Ha Gavish 6, Netanya Central, Israel, 4250706
- Owner or operator
- OLYMPUS CORPORATION (9067818)
- Roles
- Manufacturer
- First device listed
- July 6, 2026
- Registered through
- 2027
- Brand names listed
- HYDROGEL SPACER
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Hydrogel Spacer | OVB | 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 |
|---|---|---|---|---|---|---|
| August 25, 2023 | K222972 | BioProtect Balloon Implant System | OVB | Substantially Equivalent | Bioprotect, Ltd. | accessdata.fda.gov |
Compare with other makers
Updated August 25, 2023. 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.