BEUDAMED
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    FLASH-C PTCA BALLOON DILATATION CATHETER- 4.0MM X 14MM X 135CM -4.0MM X 19MM X 135CM- 4.5MM X 14MM X 135CM-4.5MM X 19MM

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Bio-Modular® Shoulder System

    FDA UDI
    Biomet Orthopedics, LLC·00887868253720·

    BIO-MODULAR SHOULDER SYSTEM

    FDA UDI
    Biomet Orthopedics, LLC·00880304213678·

    Aileron Posterior Fusion System

    FDA UDI
    Life Spine, Inc.·00190837043469·Canted Aileron Expandable Implant Caddy

    SYR 10ML PUMP COMPATIBLE SALINE 10ML FIL

    FDA Adverse Event
    Malfunction ·BD MEDICAL (BD WEST) MEDICAL SURGICAL·Product code NGT·August 28, 2019

    SYR 10ML PUMP COMPATIBLE SALINE 10ML FIL

    FDA Adverse Event
    Malfunction ·BD MEDICAL (BD WEST) MEDICAL SURGICAL·Product code NGT·September 4, 2019

    PEAK SUCTION COAGULATOR

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

    TWINFIX INTERFRAGMENTARY COMPRESSION SCREW SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    BD POSIFLUSH¿ NORMAL SALINE SYRINGE

    FDA Adverse Event
    Malfunction ·BD MEDICAL (BD WEST) MEDICAL SURGICAL·Product code NGT·August 16, 2019

    VERCISE GENUS

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC NEUROMODULATION·Product code NHL·October 20, 2023

    MAXGUARD EXTENSION SET

    FDA Adverse Event
    Malfunction ·CAREFUSION·Product code FPA·September 4, 2019

    PROGRASP FORCEPS INSTRUMENT

    FDA Adverse Event
    Malfunction ·INTUITIVE SURGICAL,INC.·Product code NAY·October 3, 2013

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    FDA Adverse Event
    Injury ·ANIMAS CORPORATION·Product code LZG·May 15, 2013

    ESSURE

    FDA Adverse Event
    Injury ·BAYER·Product code HHS·September 24, 2014

    ENDURANT ABDOMINAL STENT GRAFT SYSTEM

    FDA Adverse Event
    Injury ·MEDTRONIC CARDIOVASCULAR GALWAY·Product code MIH·June 2, 2011

    AD-TECH Medical Instrument Corporation Drill Sleeve Guides DSG-6-3-090-2.4N utilizing raw material (RM0677) from the following lots from vendor 00-0001062., AD0021502, AD0021628. Product Usage: The drill sleeve guides are accessories to the Ad-Tech Cranial Drill Bits. The Cranial Drill Bits and accessories are intended to be used for drilling holes in the skull for neurological procedures, such as brain biopsy, brain contacting electrode and electrode accessory device placement. The DSG-6.3-090-2.4N drill sleeve guides are intended to be used with the 2.4mm Cranial Drill Bit diameter.

    FDA Enforcement
    Class II ·Terminated·Ad-Tech Medical Instrument Corporation·August 1, 2018

    Model Number L231, PROPONENT DR EL MRI Pacemaker

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