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Sources: EU EUDAMED, US FDA
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FDA Enforcement
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HeliTape Absorbable Collagen Wound Dressing for Dental Surgery The Absorbable Collagen Wound Dressings for Dental Surgery are intended for use on moist or bleeding oral wounds where a stabilized blood clot can help protect the surface of the wound from further injury. Topical administration of the Absorbable Collagen Wound Dressings directly over the wound effectively controls bleeding usually within two to five minutes.
FDA Enforcement
Class II
·Terminated·Integra LifeSciences Corporation·May 22, 2013
INLIVEN CRT-P, Model Numbers: a) V284 b) V285 c) W274 d) W275 (added 7/15/2021)
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·July 21, 2021