BEUDAMED
    17 results · 22ms · Sources: EU EUDAMED, US FDA

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    FLEXPEN NEEDLE

    FDA 510(k)
    FDA Class 2 ·General Hospital

    N/A

    FDA UDI
    BIOMET MICROFIXATION, INC·00841036027056·

    InTess Lumbar Cage

    FDA UDI
    Kalitec Direct LLC·B07312K0101110·Distractor, Smooth Paddle, 11mm

    TiWAVE L Lumbar Cage System

    FDA UDI
    Kalitec Direct LLC·B07323K0101110·Distractor, Smooth Paddle, Lordotic, 11mm

    DIAMONDCOAT ULTRASONIC INSERTS

    FDA 510(k)
    FDA Class 2 ·Dental

    CARDIOIMMUNE TL CARDIAC MARKER CONTROL LEVELS 1, 2, 3, AND MULTI-PACK

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    SPECTRA WAVEWRITER

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·February 16, 2024

    QUADRA H FEMORAL STEM SIZE 2 STD

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code JDI·July 30, 2014

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·April 17, 2024

    BE-VKMO 70000 #QUADR-I HMO70000+VHK7100

    FDA Adverse Event
    Malfunction ·MAQUET CARDIOPULMONARY AG·Product code DTZ·January 5, 2015

    BE-VKMO 70000 #QUAD-I HMO70000+VHK7100

    FDA Adverse Event
    Malfunction ·MAQUET CARDIOPULMONARY AG·Product code DTZ·January 5, 2015

    BE-VKMO 70000 #QUADR-I HMO70000+VHK7100

    FDA Adverse Event
    Malfunction ·MAQUET CARDIOPULMONARY AG·Product code DTZ·January 5, 2015

    BE-VEMO 7000 #QUADR-I HMO70000+VHK7100

    FDA Adverse Event
    Malfunction ·MAQUET CARDIOPULMONARY AG·Product code DTZ·January 5, 2015

    DURATA STS OPTIM PASSIVE FIXATION

    FDA Adverse Event
    Malfunction ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code NVY·May 2, 2013

    MECHANICAL (MANUAL) WHEELCHAIR

    FDA Adverse Event
    Malfunction ·INVACARE TAYLOR STREET·Product code IOR·September 15, 2014

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO OPERATIONS MED-REL·Product code MDS·May 5, 2011

    Aurora 2 Series, Aurora 7 lighthead; Models: AUR7 (including TV models). The Aurora Series is intended to illuminate the surgical field and ensure visibility of the surgical site.

    FDA Enforcement
    Class II ·Ongoing·DKK Dai-Ichi Shomei Co., Ltd.·August 21, 2024