BEUDAMED
    21 results · 32ms · Sources: EU EUDAMED, US FDA

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    BIOMET MICROFIXATION STERNAL CLOSURE SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    POLYPERF SAFE

    FDA UDI
    PEROUSE MEDICAL·03661234014118·

    HiJAK™ Cervical

    FDA UDI
    ATLAS SPINE, INC.·M68111190800130·13mm LG Fixed 5° Lordotic, HiJAK™ Cervical

    HiJAK™ Cervical

    FDA UDI
    ATLAS SPINE, INC.·M68111190800080·8mm LG Fixed 5° Lordotic, HiJAK™ Cervical

    HiJAK™ Cervical

    FDA UDI
    ATLAS SPINE, INC.·M68111190800140·14mm LG Fixed 5° Lordotic, HiJAK™ Cervical

    HiJAK™ Cervical

    FDA UDI
    ATLAS SPINE, INC.·M68111190800120·12mm LG Fixed 5° Lordotic, HiJAK™ Cervical

    HiJAK™ Cervical

    FDA UDI
    ATLAS SPINE, INC.·M68111190800090·9mm LG Fixed 5° Lordotic, HiJAK™ Cervical

    HiJAK™ Cervical

    FDA UDI
    ATLAS SPINE, INC.·M68111190800100·10mm LG Fixed 5° Lordotic, HiJAK™ Cervical

    HiJAK™ Cervical

    FDA UDI
    ATLAS SPINE, INC.·M68111190800110·11mm LG Fixed 5° Lordotic, HiJAK™ Cervical

    APTUS FOOT 3.5 SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    OPTIBOND SOLO PLUS 3

    FDA 510(k)
    FDA Class 2 ·Dental

    HAHN TAPERED IMPLANT 4.3 X 13 MM

    FDA Adverse Event
    Injury ·PRISMATIK DENTALCRAFT, INC.·Product code DZE·February 9, 2023

    HAHN TAPERED IMPLANT Ø4.3 X 13 MM

    FDA Adverse Event
    Injury ·PRISMATIK DENTALCRAFT, INC.·Product code DZE·May 12, 2025

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·May 8, 2025

    SURPASS ACETABULAR SHELL LINER

    FDA Adverse Event
    Malfunction ·STELKAST, INC·Product code MRA·February 27, 2009

    VITEK® 2 AST-ST01 TEST KIT

    FDA Adverse Event
    Malfunction ·BIOMERIEUX, INC·Product code LON·October 24, 2017

    11.0 CM LONG ATTACHMENT

    FDA Adverse Event
    Malfunction ·DEPUY SYNTHES POWER TOOLS·Product code HBC·May 7, 2013

    VERSAFITCUP DM LINER INSERTER

    FDA Adverse Event
    Malfunction ·MEDACTA INTERNATIONAL SA·Product code MEH·May 24, 2011

    PRECISION

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC NEUROMODULATION CORP.·Product code LGW·August 12, 2008

    Ultra/Phonic Focus BP Conforming Gel Pads, UDI 00300361301021 (Primary); 10300361301028 (Package) - Product Usage: A gel pad for use on woman s areola during an ultrasound examination. Its primary purpose is for patient comfort over the loose gel and helps with nipple location during the scan, making the areola location easier to identify.

    FDA Enforcement
    Class II ·Terminated·Pharmaceutical Innovations, Inc.·August 26, 2020