device recall
saveMyofunctional Research Company USA device recall (Cls II)
October 9, 2025updated 3mo ago
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Myosa for Kids KS1 REF MyOSAKS1_Sb/Sp/Mb/Mp/Lb/Lc KS2 REF MyOSAKS2_Sb/Sc/Mb/Mc/Mp/Lb/Lc Myosa for Kids is a mouthguard in 3 different sizes (sm, med, lg) that can be used in children ages 3-15 to address breathing and myofunctional disorders. Catalog Numbers: — Reason: Due to firm mistakenly distributing product within the U.S. without FDA premarket clearance/approval. — Status: Ongoing
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