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

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    BRAINPRO, BRAINPRO ACCESS

    FDA 510(k)
    FDA Class 2 ·Neurology

    Orthopedic manual surgical instrument

    FDA UDI
    BAUI BIOTECH CO. LTD.·04715862873094·8mm Hex Socket Screw Driver

    InTess C Cervical Cage System

    FDA UDI
    Kalitec Direct LLC·B07309K0600080·Try insert, InTess C Level 1

    CosmoLock Pedicle Screw System

    FDA UDI
    Kalitec Direct LLC·B07311K0600080·Tray Insert, Lumbar Rods

    InTess Lumbar Cage

    FDA UDI
    Kalitec Direct LLC·B07312K0600080·Tray Insert, Level I

    Kalitec Disc Prep

    FDA UDI
    Kalitec Direct LLC·B07319K0600080·Tray Insert, Disc Prep 1

    FERTILITE OV

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    RICH-MAR WINNER ST4 MUSCLE STIMULATOR, INTERFERENTIAL, AND TENS DEVICE

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·March 13, 2025

    GEMSTAR SPLT SET Y-EXT W/ BACKCHK 282CM

    FDA Adverse Event
    Malfunction ·HOSPIRA COSTA RICA LTD.·Product code FRN·April 15, 2013

    UNK

    FDA Adverse Event
    Malfunction ·HOSPIRA COSTA RICA LTD.·Product code FPA·February 23, 2011

    LIBERTY CYCLER SET, SINGLE CONN./EST. DL

    FDA Adverse Event
    Malfunction ·REYNOSA MANUFACTURING·Product code FKX·April 5, 2013

    EXPRESSEW SUTURE PASSER GUN

    FDA Adverse Event
    Malfunction ·DEPUY MITEK·Product code HRX·March 11, 2011

    GEMSTAR 7 THERAPY PUMP

    FDA Adverse Event
    Malfunction ·HOSPIRA, INC.·Product code FRN·June 12, 2008

    GEMSTAR 1.2 MICRON FLTR 244CM

    FDA Adverse Event
    Malfunction ·HOSPIRA COSTA RICA LTD.·Product code FRN·December 5, 2013

    Contour¿ next GEN Blood Glucose Monitoring System

    FDA Enforcement
    Class II ·Ongoing·Ascensia Diabetes Care US, Inc.·July 26, 2023

    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