Data / Medical devices / Israel / SilverStream Medical Ltd
SilverStream Medical Ltd: FDA-registered device maker in Rosh Ha Ayin Central, Israel, 2 510(k) clearances
SilverStream Medical Ltd is registered with the FDA (registration 3005674466) in Rosh Ha Ayin Central, Israel. It lists 1 device type. The FDA files 2 510(k) clearances under its listings, the newest dated October 8, 2020. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3005674466
- Address
- 26 Shabazi St, Rosh Ha Ayin Central, Israel, 4802126
- Owner or operator
- SilverStream Medical LTD (9081441)
- Roles
- Specification developer
- First device listed
- February 15, 2011
- Registered through
- 2026
- Brand names listed
- SilverStream, SilverStream Gel
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Dressing, Wound, Drug | FRO | U | Specification developer | 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 |
|---|---|---|---|---|---|---|
| October 8, 2020 | K200767 | SilverStream Gel | FRO | Substantially Equivalent | Enzysurge , Ltd. | accessdata.fda.gov |
| December 10, 2009 | K093227 | SILVERSTREAM AND DERMASEPT | FRO | Substantially Equivalent | Enzysurge , Ltd. | accessdata.fda.gov |
Compare with other makers
Updated October 8, 2020. 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.