BEUDAMED
    9 results · 18ms · Sources: EU EUDAMED, US FDA

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    DURACON TOTAL KNEE SYSTEM TIBIAL COMPONENTS

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Duo Lumbar Interbody Fusion Device

    FDA UDI
    SPINEOLOGY INC.·M7402915512·Duo, Lordotic, 55 x 12mm

    ACCUFLATE

    FDA 510(k)
    FDA Class 1 ·General, Plastic Surgery

    ANTERIOR NECK CONTOUR COIL

    FDA 510(k)
    FDA Class 2 ·Radiology

    ITREL 3

    FDA Adverse Event
    Malfunction ·MDT PUERTO RICO OPERATIONS CO, MED REL·Product code LGW·November 5, 2010

    FLAT MESH

    FDA Adverse Event
    Injury ·DAVOL INC., SUB. C.R. BARD, INC.·Product code FTL·January 9, 2013

    ECHELON LINEAR CUTTER

    FDA Adverse Event
    Malfunction ·ETHICON ENDO-SURGERY, LLC.·Product code GDW·July 7, 2014

    Breast Augmentation Pack, part number AMS1786(A Breast Augmentation Pack, part number AMS2790(A Breast Augmentation Pack, part number AMS3324(B Breast Augmentation Pack, part number AMS4382 Breast Augmentation Pack, part number AMS4382(A Breast Augmentation Pack, part number AMS4382(B Breast Augmentation Pack, part number AMS4392 Breast Augmentation Pack, part number PSS3430

    FDA Enforcement
    Class II ·Terminated·Windstone Medical Packaging, Inc.·March 8, 2017

    Alaris Syringe Pump, Model No. 8110. Delivers fluids. Expansion of Affected Units: BOM Housing Assembly Service, Part No. 49000226, and Lower Housing/Carriage Block Assembly, Part No. 148188-100.

    FDA Enforcement
    Class I ·Terminated·CareFusion 303, Inc.·August 26, 2015