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HealiAid Dental Collagen Wound Dressing

MAXIGEN BIOTECH INC. · Model HADB101030 · UDI-DI 04714691213552

OLR
10
510(k) clearances
10
Adverse events (3 deaths)
1
Recalls
30
Facilities

Recalls

DateFirmReason
2022-02-21SA3, LLCDue to failure of microbial testing for total aerobic microbial count (TAMC).

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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.