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

    Get notified when this changes

    We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.
    Filters Regulation: Us FDA ×

    Monarch Endoscopy Platform (Monarch Platform)

    FDA 510(k)
    FDA Class 2 ·Ear, Nose, Throat

    M2a-Magnum™

    FDA UDI
    Biomet Orthopedics, LLC·00887868474873·

    RECAP HIP INSTRUMENTATION

    FDA UDI
    Biomet Uk Ltd·05019279050017·

    MSI Precision Specialty Instruments

    FDA UDI
    Med Saver, Inc.·00194613055721·Bainbridge Thyroid Forceps, Curved, Overall Len...

    Sklar®

    FDA UDI
    SKLAR CORPORATION·10649111135521·BAINBRIDGE THYROID FCP CVD 6"

    VARIAX SUPERIOR AND ANTERIOR, LATERAL AND MIDSHAFT CLAVICLE PLATES VARIAX AIMING BLOCKS & JOYSTICK

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    TITAN

    FDA 510(k)
    FDA Class 2 ·Neurology

    M2A-MAGNUM PF CUP 46ODX40ID

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code KWA·October 9, 2018

    SELEX/MAGNUM MOD HD 40MM -6

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code LZO·October 9, 2018

    HEARTMATE II LVAS

    FDA Adverse Event
    Death ·THORATEC CORPORATION·Product code DSQ·June 17, 2013

    FINELINE II

    FDA Adverse Event
    Injury ·CPI - DEL CARIBE·Product code NVN·July 24, 2011

    MEDICHOICE

    FDA Adverse Event
    Malfunction ·OWEN'S & MINOR·Product code HRQ·September 28, 2014

    Medtronic MiniMed(TM) Quick-set(TM) (MMT-394, 394T, 399, 399T, 387, 387T, 398, 398T, 397, 397T, 386, 386T, 396, 396T)

    FDA Enforcement
    Class II ·Ongoing·Medtronic Inc.·November 29, 2017

    various polyethylene implants Knees Revision Tibial Tray Systems Oxford Partial Knee Orthopedic Salvage System Vanguard Complete Knee System Vanguard SSK Revision System Biomet Patella Maxim Complete Knee System Biomet Series A Patella Vanguard 360 Revision System Vanguard Deep Dish Rotating Platform Biomet CP Bearings Product Usage: For use in total knee arthroplasty. Limb salvage joint reconstruction. Partial knee replacement.

    FDA Enforcement
    Class II ·Terminated·Zimmer Biomet, Inc.·April 26, 2017

    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