BEUDAMED
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    CEREBRAL STATE MONITOR - CSM

    FDA 510(k)
    FDA Class 2 ·Neurology

    JOBST forMen

    FDA UDI
    BSN MEDICAL, INC.·04042809871791·FOR MEN 15-20 MM HG THIGH MICRO DOT BAND OPEN T...

    WISEBANDS SKIN CLOSURE DEVICE

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

    LEVEEN ELECTRODE

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

    PLATE, FIXATION, BONE

    FDA Adverse Event
    Malfunction ·SYNTHES (USA)·Product code HRS·January 21, 2016

    MATRIXNEURO STERILE KIT STD 4

    FDA Adverse Event
    Malfunction ·SYNTHES GMBH·Product code JEY·December 19, 2013

    TI MATRIXNEURO BURR HOLE COVER24MM

    FDA Adverse Event
    Injury ·SYNTHES (USA)·Product code JEY·October 28, 2015

    EON MINI

    FDA Adverse Event
    Malfunction ·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·April 4, 2013

    9800

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·February 15, 2011

    ATRIAL J SELUTE PICOTIP

    FDA Adverse Event
    Malfunction ·CARDIAC PACEMAKERS, INC·Product code DTB·May 8, 2008

    MATNEU SCR Ø1.5 SELF-DRILL L4 TAN 1U I/C

    FDA Adverse Event
    Malfunction ·SYNTHES GMBH·Product code HWC·June 23, 2013

    MATNEU SCR Ø1.5 SELF-DRILL L4 TAN 4U I/C

    FDA Adverse Event
    Malfunction ·SYNTHES BETTLACH·Product code JEY·August 28, 2015

    SORIN VVR 4000I AND 4000I SMARXT FILTERED HARDSHELL VENOUS RESERVOIR

    FDA Adverse Event
    Death ·SORIN GROUP ITALIA SRL·Product code DTN·October 3, 2016

    Thoratec HeartMate 3, LVAS Implant Kit, REF:106524INT, Sterile EO, RxOnly

    FDA Enforcement
    Class I ·Ongoing·Thoratec Corp.·May 8, 2024

    Thoratec HeartMate 3, LVAS Implant Kit, REF:106524US, Sterile EO, RxOnly

    FDA Enforcement
    Class I ·Ongoing·Thoratec Corp.·May 8, 2024

    Exactech Equinoxe REVERSE SHOULDER,42mm Humeral Liner, a) +0mm, Item number 320-42-00, b) +2.5mm, Item Number 320-42-03; Shoulder Arthroplasty

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·April 10, 2024

    Quadra Assura, Sterile EO, Model #/ Part #: CD3265-40/100042335, 100059846; CD3265-40Q/100042336, 100059847; CD3267-40/100042956, 100043569, 100059961, 100078810; CD3267-40Q/100043132, 100043539, 100059917, 100059956, 100078904; CD3365-40C/100080435, 100080436; CD3365-40Q/100080426, 100080427; CD3367-40/100078813, 100079497, 100096097; CD3367-40C/100078597, 100079174, 100079450, 100079490, 100105524; CD3367-40Q/100078851, 100079212, 100079504, 100096098; CD3367-40QC/100078656, 100079193, 100079498, 100079524, 100105513, 100105514, 100138185, 100138213; CD3385-40C/100080778; CD3385-40QC/100080780, 100105489

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