BEUDAMED
    9 results · 5ms · Sources: EU EUDAMED, US FDA

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    Filters Classification: Class Ii × Status: Ongoing × Clear all

    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:

    FDA Enforcement
    Class II ·Ongoing·Myofunctional Research Company USA·December 24, 2025

    Medline Convenience Kits: 1) DRAPE PACK, Model Number: DYNJ35363A; 2) SICK KIDS-GENERAL CUSTOM SPLIT, Model Number: SPTPCD10005

    FDA Enforcement
    Class II ·Ongoing·Medline Industries, LP·February 25, 2026

    Medline Convenience Kits: 1) DRAPE PACK, Model Number: DYNJ35363A; 2) SICK KIDS-GENERAL CUSTOM SPLIT, Model Number: SPTPCD10005

    FDA Enforcement
    Class II ·Ongoing·Medline Industries, LP·May 13, 2026

    medex TranStar KIDS KIT 31IN. CLOSED BLOOD SAMPLE KIT with 30cc/hr Flush Device 10/EA, Product Code REF MX9544

    FDA Enforcement
    Class II ·Ongoing·Smiths Medical ASD, Inc.·October 30, 2024

    medex TranStar KIDS KIT 34IN. CLOSED BLOOD SAMPLE KIT with 30cc/hr Flush Device 10/EA, Product Code REF MX9545

    FDA Enforcement
    Class II ·Ongoing·Smiths Medical ASD, Inc.·October 30, 2024

    medex TranStar KIDS KIT 10IN. CLOSED BLOOD SAMPLE KIT with 30cc/hr Flush Device 10/EA, Product Code REF MX9548

    FDA Enforcement
    Class II ·Ongoing·Smiths Medical ASD, Inc.·October 30, 2024

    medex TranStar KIDS KIT 19IN. CLOSED BLOOD SAMPLE KIT with 30cc/hr Flush Device 10/EA, Product Code REF MX9543

    FDA Enforcement
    Class II ·Ongoing·Smiths Medical ASD, Inc.·October 30, 2024

    medex TranStar KIDS KIT 7INCH CLOSED BLOOD SAMPLE KIT with 30cc/hr Flush Device 10/EA, Product Code REF MX9547

    FDA Enforcement
    Class II ·Ongoing·Smiths Medical ASD, Inc.·October 30, 2024

    Firefly Floorsitter, Firefly Splashy Bathseat, Firefly GoTo Seat - Product Usage: The Splashy Bath-Seat is a Portable bath seat for children aged 1-8, The GoTo Seat is a light-weight, portable, postural support seat for kids, aged between 1 and 8 with disabilities.

    FDA Enforcement
    Class II ·Ongoing·James Leckey Design Ltd·April 15, 2020