BEUDAMED
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    P2 POLYETHER

    FDA 510(k)
    FDA Class 2 ·Dental

    Stryker Locking Screw, Fully Threaded T2 Tibia ¿5x35 mm Catalog Number: 18965035S - Product Usage: Stryker implants are single use devices intended for the temporary fixation, correction or stabilization of bones.

    FDA Enforcement
    Class II ·Terminated·Stryker GmbH·June 24, 2020

    MITAYA MFG. CO., LTD.

    FDA registration
    MITAYA MFG. CO., LTD.·1 product·🇯🇵 Japan

    PHOTON MULTI-PLATFORM SYSTEM, MODEL Z-12834-X & Z-13175-X

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

    BIONOSTICS GLUCOSE QUALITY CONTROL SOLUTION FOR USE WITH THE FASTTAKE COMPACT BLOOD GLUCOSE MONITORING SYSTEM

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    ECHOTIP CELIAC PLEXUS NEUROLYSIS NEEDLE

    FDA Adverse Event
    Injury ·COOK IRELAND LTD·Product code BSP·November 21, 2019

    PULSE GEN MODEL 103

    FDA Adverse Event
    Malfunction ·CYBERONICS INC·Product code LYJ·April 2, 2013

    PALINDROME CATHETER

    FDA Adverse Event
    Malfunction ·ARGYLE (SHERIDAN)·Product code MPB·March 21, 2011

    MED-EL COMBI 40+ COCHLEAR IMPLANT SYSTEM

    FDA Adverse Event
    Malfunction ·MED-EL ELEKTROMEDIZINISCHE GERAETE, GMBH·Product code MCM·April 16, 2008

    SYMMETRY

    FDA Adverse Event
    Malfunction ·SYMMETRY SURGICAL INC·Product code KBD·December 22, 2023

    ECHOTIP ULTRA CELIAC PLEXUS NEUROLYSIS NEEDLE

    FDA Adverse Event
    Malfunction ·COOK IRELAND LTD·Product code FCG·July 5, 2023

    Quadra Assura, Model No. CD3265-40, CD3265-40Q, CD3365-40C, CD3365-40Q. Quadra Assura MP, Model No. CD3269-40, CD3269-40Q, CD3369-40C. Fortify and Fortify Assura implantable cardioverter defibrillators (ICDS) are intended to provided ventricular anti-tachycardia pacing and ventricular defibrillation for automated treatment of life threatening ventricular arrhythmias. The devices may also be programmed to provide single or dual chamber bradycardia pacing. Unify and Unify Assura cardiac resynchronization therapy defibrillators (CRTDs) are intended to provide ventricular anti-tachycardia pacing and ventricular defibrillation for automated treatment of life-threatening ventricular arrhythmias. The devices may also be programmed to provide single or dual chamber bradycardia pacing, in additional to cardiac resynchronization therapy via left ventricular pacing

    FDA Enforcement
    Class I ·Terminated·St Jude Medical Inc.·November 2, 2016