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Mendit Reload Set
ESCALA MEDICAL LTD · Model Mendit Reload Set - Permanent Suture (ePTFE 2-0) · UDI-DI 07290019174103
PBQ
Prescription
1
510(k) clearances
65
Adverse events
1
Recalls
9
Facilities
Description
The Mendit is a single-use repair system which enables anchoring of sutures to ligaments of the pelvic floor. The Mendit Reload Set comprises two Applicator Cartridges, each with an Anchor-Suture unit (pre-loaded in the Applicator Cartridge). The Mendit is a disposable device supplied sterile, pre-loaded with the anchor-suture unit, and ready for use.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2021-12-13 | FEMSelect Ltd | Certain lots may not have been packaged wth the Channel Tube Limiter. |
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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.