BEUDAMED
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    REAL INTELLIGENCE CORI

    FDA 510(k)
    FDA Class 2 ·Neurology

    Chord-X Premeasured Loops and Suture System

    FDA UDI
    ON-X LIFE TECHNOLOGIES, INC.·00813570020145·Artificial chordal replacement prosthesis

    Chord-X Premeasured Loops and Suture System

    FDA UDI
    ON-X LIFE TECHNOLOGIES, INC.·00813570020046·Artificial chordal replacement prosthesis

    FULL-SIZE LID W/RETENTION PLATE SILVER

    FDA Adverse Event
    Malfunction ·AESCULAP AG·Product code FRG·October 14, 2016

    GENESIS HEALTH TECHNOLOGIES BLOOD GLUCOSE MONITORING SYSTEM

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    ENDOCERVICAL BLOCK NEEDLE

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

    GORE EXCLUDER AAA ENDOPROSTHESIS

    FDA Adverse Event
    Injury ·W.L. GORE & ASSOCIATES·Product code MIH·March 27, 2013

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·August 31, 2024

    BI-METRIC HIP LATERALISED FEMORAL STEM

    FDA Adverse Event
    Injury ·BIOMET UK LTD.·Product code LZO·March 2, 2017

    6F ANGIO-SEAL VASCULAR CLOSURE DEVICE VIP

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL·Product code MGB·November 4, 2008

    PROMUS ELEMENT EVEROLIMUS-ELUTING CORONARY STENT SYSTEM

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC - GALWAY·Product code NIQ·August 24, 2011

    RESTORE ADVANCED

    FDA Adverse Event
    Injury ·IPG MFG SWITZERLAND·Product code LGW·July 11, 2013

    PROLENE HERNIA SYSTEM

    FDA Adverse Event
    Injury ·ETHICON INC.·Product code FTL·April 1, 2019

    PROLENE POLYPROPYLENE SUTURE

    FDA Adverse Event
    Injury ·ETHICON INC.·Product code GAW·April 1, 2019

    GORE EXCLUDER AAA ENDOPROSTHESIS

    FDA Adverse Event
    Injury ·W. L. GORE & ASSOCIATES·Product code MIH·September 18, 2013

    PIPELINE

    FDA Adverse Event
    Injury ·MICRO THERAPEUTICS, INC. DBA EV3·Product code OUT·March 31, 2020

    ORTHOSIS, PEDICLE SPINAL FIXATION

    FDA Adverse Event
    Injury ·OBERDORF SYNTHES PRODUKTIONS GMBH·Product code MNI·May 1, 2019

    Omnidiagnost Classic, Product Codes 70859, 708023, 708024, 708025 Product Usage: The Philips OmniDiagnost is a multi-functional, universal X-ray system with remote-controlled facilities. It performs a wide range of routine examinations and interventional procedures include: Gastro-intestinal examination Urography Bronchography Arthrography Hysterography Myelography Lymphography Skeletal radiography Tomography Venography/phlebography Special procedures that require subtracted and non-subtracted digital imaginginclude: Angiography Peripheral angiography (bolus chasing) Vascular and non-vascular interventional procedures.

    FDA Enforcement
    Class II ·Terminated·Philips North America, LLC·April 3, 2019