BEUDAMED
    12 results · 6ms · Sources: EU EUDAMED, US FDA

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    Filters FDA Enforcement × Classification: Class Ii × Clear all

    Medline medical procedure convenience kits labeled as: 1) MEM MAXILLOFACIAL PACK-LF, Kit SKU DYNJ0660040R; 2) PLASTICS VCH, Kit SKU DYNJ39225K; 3) WT BREAST PACK, Kit SKU DYNJ46620I; 4) ENDO / AUG PACK, Kit SKU DYNJ59250I; 5) KMC PLASTIC/GEN PACK-LF, Kit SKU DYNJ65980J; 6) PLASTICS PACK, Kit SKU DYNJ68288A; 7) IMPLANT REMOVAL KIT, Kit SKU MNS13035; 8) PLASTICS PACK-LF, Kit SKU PHS41746D.

    FDA Enforcement
    Class II ·Ongoing·Medline Industries, LP·February 4, 2026

    Accusorb MRI MAC7001 Part Number: MRI-01 MRI-Large Blanket Various Sizes Product Usage: Radio frequency shielding blankets and body-part covers for the MRI environment.

    FDA Enforcement
    Class II ·Terminated·MWT Materials, Inc.·January 27, 2016

    Accusorb MRI MAC7004 Part Number: MRI-04 MRI-Poncho Product Usage: Radio frequency shielding blankets and body-part covers for the MRI environment.

    FDA Enforcement
    Class II ·Terminated·MWT Materials, Inc.·January 27, 2016

    Accusorb MRI MAC7030 Product Usage: Radio frequency shielding blankets and body-part covers for the MRI environment.

    FDA Enforcement
    Class II ·Terminated·MWT Materials, Inc.·January 27, 2016

    Accusorb MRI MAC7007 Part Number: MRI-07 MRI-Breast Shield Product Usage: Radio frequency shielding blankets and body-part covers for the MRI environment.

    FDA Enforcement
    Class II ·Terminated·MWT Materials, Inc.·January 27, 2016

    Accusorb MRI MAC7002 Part Number: MRI-02 MRI-Arm Sleeve Various Sizes Product Usage: Radio frequency shielding blankets and body-part covers for the MRI environment.

    FDA Enforcement
    Class II ·Terminated·MWT Materials, Inc.·January 27, 2016

    Accusorb MRI MAC7009 Part Number: MRI-09 MRI- Leg Wrap Blanket Various Sizes Product Usage: Radio frequency shielding blankets and body-part covers for the MRI environment.

    FDA Enforcement
    Class II ·Terminated·MWT Materials, Inc.·January 27, 2016

    Accusorb MRI MAC7005 Part Number: MRI-05 Leg Wrap Product Usage: Radio frequency shielding blankets and body-part covers for the MRI environment.

    FDA Enforcement
    Class II ·Terminated·MWT Materials, Inc.·January 27, 2016

    Accusorb MRI MAC7008 Part Number: MRI-08 MRI-Boot Product Usage: Radio frequency shielding blankets and body-part covers for the MRI environment.

    FDA Enforcement
    Class II ·Terminated·MWT Materials, Inc.·January 27, 2016

    Accusorb MRI MAC7010 Product Usage: Radio frequency shielding blankets and body-part covers for the MRI environment.

    FDA Enforcement
    Class II ·Terminated·MWT Materials, Inc.·January 27, 2016

    Accusorb MRI MAC7006 Part Number: MRI-06 MRI-Large Torso Wrap Product Usage: Radio frequency shielding blankets and body-part covers for the MRI environment.

    FDA Enforcement
    Class II ·Terminated·MWT Materials, Inc.·January 27, 2016

    Accusorb MRI MAC7003 Part Number: MRI-03 U (Upper) and MRI-03 L (Lower) Product Usage: Radio frequency shielding blankets and body-part covers for the MRI environment.

    FDA Enforcement
    Class II ·Terminated·MWT Materials, Inc.·January 27, 2016