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Dynarex ActiSplint

Dynarex Corporation · Model 3530 · UDI-DI 00616784353029

NOC
0
510(k) clearances
13
Adverse events
1
Recalls
164
Facilities

Description

Dynarex ActiSplint Finger Version, Finger Splints, Breathable, Red/Charcoal Gray

Recalls

DateFirmReason
2017-11-013M Company - Health Care BusinessMold was found on the non-patient contact surfaces of the product and was identified as Aspergillus candidus.

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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.