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E-Guide Soft
Envisiontec GmbH · Model RES-01-3115 · UDI-DI 04260683220140
KXF
Prescription
10
510(k) clearances
552
Adverse events (6 deaths)
2
Recalls
369
Facilities
Description
E-Guide Soft is a light-curing material for the additive manufacturing of nasopharyngeal and oropharyngeal swabs
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2023-02-03 | Avanos Medical, Inc. | Incorrect expiration date. |
| 2013-03-26 | Owens & Minor Distribution, Inc. | Owens & Minor Distribution, Inc. is conducting a market withdrawal of MediChoice Applicator OB-GYN 8 inch product that does not meet our quality standards because the rayon may loo |
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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.