Data / Medical devices / Israel / Equashield Medical Ltd
Equashield Medical Ltd: FDA-registered device maker in Tefen Northern, Israel, 3 510(k) clearances
Equashield Medical Ltd is registered with the FDA (registration 3008468447) in Tefen Northern, Israel. It lists 4 device types. The FDA files 3 510(k) clearances under its listings, the newest dated February 17, 2023. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3008468447
- Address
- Tefen Industrial Park POB 12, Tefen Northern, Israel, 2495900
- Owner or operator
- EQUASHIELD MEDICAL LTD (10032271)
- Roles
- Manufacturer
- First device listed
- December 3, 2017
- Registered through
- 2026
- Brand names listed
- CellSHIELD®, Luer Lock Protective Cover, Sampling Kit Syringe
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Administration Set Securement Device | PUK | 1 | Manufacturer | accessdata.fda.gov |
| Closed Antineoplastic And Hazardous Drug Reconstitution And Transfer System | ONB | 2 | Manufacturer | accessdata.fda.gov |
| Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use | LXG | 1 | Manufacturer | accessdata.fda.gov |
| Tube, Tissue Culture | KJG | 1 | 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 |
|---|---|---|---|---|---|---|
| February 17, 2023 | K221513 | Equashield Closed System Transfer Device | ONB | Substantially Equivalent | Equashield Medical , Ltd. | accessdata.fda.gov |
| July 3, 2017 | K170706 | Equashield Closed System drug Transfer Device (CSTD) | ONB | Substantially Equivalent | Equashield Medical , Ltd. | accessdata.fda.gov |
| November 5, 2015 | K150219 | Equashield Closed System drug Transfer Device (CSTD) | ONB | Substantially Equivalent | Equashield Medical , Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Closed Antineoplastic And Hazardous Drug Reconstitution And Transfer System
- All makers of Administration Set Securement Device
- All makers of Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use
- All makers of Tube, Tissue Culture
Updated February 17, 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.