BEUDAMED
    14 results · 29ms · Sources: EU EUDAMED, US FDA

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    DDS STABILIZATION SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Z-Evo

    FDA UDI
    NUSMILE, LTD.·00810092938637·Endodontic motor with integrated apex locator w...

    SchureMed

    FDA UDI
    SCHUERCH CORPORATION·00810014605296·MAQUET 1130 SPLIT LEG 3" SOFTCARE

    Merit Medical®

    FDA UDI
    Merit Medical Systems, Inc.·00884450180471·

    NA

    FDA UDI
    STRYKER CORPORATION·07613327052510·Insert, Babcock Grasper

    RADIOTHERAPEUTICS RF 3000 RADIOFREQUENCY GENERATOR

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    PROTRACT PRESS FIT HIP STEM-HA COATED

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    TRUEBALANCE

    FDA Adverse Event
    Malfunction ·NIPRO DIAGNOSTICS, INC.·Product code NBW·August 13, 2014

    LUX 1440

    FDA Adverse Event
    Malfunction ·PALOMAR MEDICAL TECHNOLOGIES, INC.·Product code GEX·May 5, 2012

    XIENCE SIERRA EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    FDA Adverse Event
    Injury ·ABBOTT VASCULAR·Product code NIQ·September 15, 2020

    CD HORIZON SPINAL SYSTEM

    FDA Adverse Event
    Malfunction ·MDT SOFAMOR DANEK PUERTO RICO MFG·Product code KWP·April 26, 2013

    ACCU-CHEK FLEXLINK PLUS

    FDA Adverse Event
    Malfunction ·ROCHE INSULIN DELIVERY SYSTEMS INC·Product code FRN·April 6, 2011

    FREESTYLE LITE

    FDA Adverse Event
    Malfunction ·ABBOTT DIABETES CARE INC.·Product code LFR·July 21, 2008

    Marathon Flow Directed Micro Catheter, UltraFlow HPC Flow Directed Micro Catheter Marathon Flow: The device is intended to access periphera and neurovasculature for the controlled selective infusion of physician-specified therapeutics agents such as embolization materials and of diagnostic materials such as contrast media. UltraFlow HPC Flow: The device is intended for the controlled selective infusion of physician-specified pharmacologic agents or contrast media into the distal vasculature of the peripheral and neuroanatomy. It is not intended for use in the coronary vasculature. Catalog No. 105-5055V02 105-5055V02 105-5055V05 105-5065V02 105-5065V05 105-5066V02 105-5066V05

    FDA Enforcement
    Class I ·Terminated·Micro Therapeutics Inc, Dba Ev3 Neurovascular·November 16, 2016