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

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    Attain Command + SureValve Delivery System, Attain Select II + SureValve delivery system

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    VASOPOUSE DEEP VEIN THROMBOSIS COMPRESSION DEVICE MODEL IPCS, MODEL SQS

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    POWDER-FREE RADIATION ATTENUATING NEOPRENE SURGICAL GLOVE (BLACK)

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

    RESOLUTION CLIP DEVICE

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code MND·November 6, 2008

    TOTALCARE BED

    FDA Adverse Event
    Malfunction ·HILL-ROM, INC.·Product code FNL·July 15, 2011

    PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)

    FDA Adverse Event
    Malfunction ·INVACARE SUZHOU·Product code CAW·July 12, 2013

    ASPRIRE Cristalle Mammography System (cleared under K212873) installed with the ASPIRE Cristalle Digital Breast Tomosynthesis (DBT) Option (approved under P160031).

    FDA Recall
    Open, Classified ·FUJIFILM Healthcare Americas Corporation·Product code OTE·June 11, 2025

    ASPRIRE Cristalle Mammography System (cleared under K212873) installed with the ASPIRE Cristalle Digital Breast Tomosynthesis (DBT) Option (approved under P160031).

    FDA Enforcement
    Class II ·Ongoing·FUJIFILM Healthcare Americas Corporation·August 6, 2025

    SpF PLUS-Mini (60 ¿A/W) Implantable Spinal Fusion Stimulator SpF PLUS-Mini Implantable Fusion Stimulators are indicated as a spinal fusion adjunct to increase the probability of fusion success in 1 or 2 levels

    FDA Enforcement
    Class I ·Terminated·Zimmer Biomet, Inc.·November 7, 2018

    Quadra Assura MP, Sterile EO, Model #/ Part #: CD3269-40/100043177; CD3269-40Q/100043178; CD3271-40/100043130; CD3271-40Q/100043191; CD3369-40C/100080339, 100080478; CD3369-40Q/100080439, 100080476, 100105528; CD3371-40/100078814, 100079232, 100079513; CD3371-40C/100078639, 100079231, 100079478, 100105493, 100105494; CD3371-40Q/100078815,100079282, 100079479, 100138237; CD3371-40QC/100078640, 100079165, 100079506, 100079541, 100105505, 100105506, 100138173, 100138179, 100138222, 100138234; CD3387-40C/100105525; CD3387-40QC/100138158

    FDA Enforcement
    Class II ·Terminated·St Jude Medical Inc.·July 4, 2018