BEUDAMED
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    Pitkar Spinal Pedicle Screw System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    MEDI

    FDA UDI
    MEDI MANUFACTURING, INC.·04049772777501·LUMBAMED PLUS FLEX PAD M SILVER III

    MEDI

    FDA UDI
    MEDI MANUFACTURING, INC.·04049772777655·LUMBAMED BASIC DORSAL STAYS M SILVER III

    MEDI

    FDA UDI
    MEDI MANUFACTURING, INC.·00636257125847·30-40 MV FOR MEN CLSC CALF STD GREY III

    Prospera Spectruum Negative Pressure Wound Therapy System

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

    ULTRASONIC SCALER

    FDA 510(k)
    FDA Class 2 ·Dental

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·August 28, 2025

    PRIMEADVANCED

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code LGW·January 20, 2015

    G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code MDS·November 10, 2014

    COLLEAGUE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·September 9, 2011

    1MM FLUTED BALL, STANDARD

    FDA Adverse Event
    Malfunction ·DEPUY SYNTHES POWER TOOLS·Product code HBC·July 17, 2013

    RESTORE ADVANCED

    FDA Adverse Event
    Injury ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·August 29, 2014

    BD VACUTAINER 9NC 0.129M PLUS BLOOD COLLECTION TUBES

    FDA Adverse Event
    Malfunction ·BECTON, DICKINSON AND COMPANY (BD)·Product code JKA·March 17, 2021

    Model Number L111, ESSENTIO DR SL MRI Pacemaker

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·October 22, 2025

    Boston Scientific TELIGEN, Implantable Cardiac Defibrillator models E102, E110, the following models are not available in the US: models F102, F110, F111. Sterilized using ethylene oxide. Boston Scientific, 4100 Hamline Avenue North, St. Paul, MN 55112-5798 USA. Indicated for patients who are at risk for sudden cardiac death due to ventricular arrhythmias and may require pacing support.

    FDA Enforcement
    Class II ·Terminated·Boston Scientific CRM Corp·October 23, 2013