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Burkhart Non-Woven Sponges

CROSSTEX INTERNATIONAL, INC. · Model ENC4NWLBK · UDI-DI 10815878028486

EFN
10
510(k) clearances
7
Adverse events
2
Recalls
206
Facilities

Recalls

DateFirmReason
2022-08-02Carwild CorporationSterility with new cotton source not validated
2016-03-31American Surgical CompanyProduct packaging defective compromising sterility

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Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.

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Data 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.