Data / Medical devices / Israel / FEMSelect Ltd
FEMSelect Ltd: FDA-registered device maker in Modi'in Central, Israel, 1 510(k) clearance
FEMSelect Ltd is registered with the FDA (registration 3010892271) in Modi'in Central, Israel. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated July 6, 2016. 1 recall event names it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3010892271
- Address
- HaMa'ayan 2 First Floor, Modi'in Central, Israel, 7177871
- Owner or operator
- FEMSelect Ltd (10053647)
- Roles
- Manufacturer
- First device listed
- December 27, 2016
- Registered through
- 2026
- Brand names listed
- EnPlace
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Fixation, Non-Absorbable Or Absorbable, For Pelvic Use | PBQ | 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 |
|---|---|---|---|---|---|---|
| July 6, 2016 | K160569 | NeuGuide | PBQ | Substantially Equivalent | Pop Medical Solutions | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| December 13, 2021 | 89309 | Class II | Ongoing | The EnPlace is a single use trans-vaginal pelvic floor repair system which enables delivery of a tissue anchor to the ligaments of the vaginal cavity. The anchors are pre-loaded inside the device shaft and are ready for | Certain lots may not have been packaged wth the Channel Tube Limiter. | accessdata.fda.gov |
Compare with other makers
Updated July 6, 2016. 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.