BEUDAMED
    39 results · 27ms · Sources: EU EUDAMED, US FDA

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    MIDAS TOUCH BLUE NITRILE EXAMINATION GLOVES-POWDERED

    FDA 510(k)
    FDA Class 1 ·General Hospital

    Custom Procedure Kit

    FDA UDI
    MEDIVATORS INC.·40677964001794·Custom Procedure Kit

    GeneXpert Dx System

    FDA UDI
    CEPHEID·07332940006709·XPERT, GENEXPERT DX SYSTEM

    DERMATOME

    FDA Adverse Event
    Injury ·ZIMMER INC·Product code GFD·September 13, 2007

    QB1 NMES System

    FDA UDI
    Motive Health, Inc.·00854816006493·QB1 NMES System; 2X-LARGE, SHORT, LEFT

    CURE LP

    FDA UDI
    MEDITECH SPINE, LLC·B167900001390·

    FlowLogic Agile

    FDA UDI
    SONENDO, INC.·00810209420321·FlowLogic Agile Shaping File 35/.04, 25mm

    CURE LP

    FDA UDI
    SpineArt SA·07640270060637·ANTERIOR LUMBAR PLATE L39

    CURE LP

    FDA UDI
    MEDITECH SPINE, LLC·B167S1900001390·

    SJM TAILOR ANNULOPLASTY RING, MODEL TARN

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    INVIGRA MALE LATEX CONDOM YELLOW COLORED AND BANANA FLAVORED

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    CARDIOSAVE HYBRID W/ E/F PLUG

    FDA Adverse Event
    Malfunction ·DATASCOPE CORP.·Product code DSP·January 9, 2025

    GLIDESCOPE GVL 3

    FDA Adverse Event
    Malfunction ·VERATHON MEDICAL (CANADA) ULC.·Product code CCW·February 14, 2013

    HEART START XL

    FDA Adverse Event
    Malfunction ·PHILIPS HEALTHCARE·Product code MKJ·February 18, 2011

    EXPRESS2 MONORAIL CORONARY STENT DELIVERY SYSTEM

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC·Product code MAF·February 19, 2008

    CELLO BALLOON GUIDE CATHETER

    FDA Adverse Event
    Death ·FUJI SYSTEMS CORPORATION·Product code DQY·May 12, 2021

    HARMONIC SCALPEL CURVED SHEAR (EXACT CODE UNKNOWN)

    FDA Adverse Event
    Injury ·ETHICON ENDO-SURGERY, LLC.·Product code GEI·December 9, 2019

    LEEP SYSTEM 1000 WORKSTN

    FDA Adverse Event
    Malfunction ·COOPERSURGICAL, INC.·Product code HGI·December 20, 2019

    Chiba Biopsy Needle - Used for aspiration biopsy. REFERENCE PART NUMBER (RPN) ORDER NUMBER (GPN): 1) DCHN-18-10.0 G01559 2) DCHN-18-10.0-U G05040 3) DCHN-18-15.0 G00850 4) DCHN-22-10.0 G00852 5) DCHN-22-10.0-U G03978 6) DCHN-22-15.0 G00012 7) DCHN-22-15.0-U G03314 8) DCHN-22-20.0 G00013 9) DCHN-22-20.0-U G04338

    FDA Recall
    Open, Classified ·Cook Incorporated·Product code MJG·March 1, 2024

    Chiba Biopsy Needle - Used for aspiration biopsy. REFERENCE PART NUMBER (RPN) ORDER NUMBER (GPN): 1) DCHN-18-10.0 G01559 2) DCHN-18-10.0-U G05040 3) DCHN-18-15.0 G00850 4) DCHN-22-10.0 G00852 5) DCHN-22-10.0-U G03978 6) DCHN-22-15.0 G00012 7) DCHN-22-15.0-U G03314 8) DCHN-22-20.0 G00013 9) DCHN-22-20.0-U G04338

    FDA Enforcement
    Class II ·Ongoing·Cook Incorporated·April 24, 2024