BEUDAMED
    18 results · 21ms · Sources: EU EUDAMED, US FDA

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    LUMENIS FAMILY OF IPL SYSTEMS AND COMBINATION IPL/ND:YAG SYSTEMS

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

    Stryker Locking Screw, Fully Threaded T2 Tibia ¿5x45 mm Catalog Number: 18965045S - 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

    WAKO CRP-UL, CRP-UL CALIBRATOR SET

    FDA 510(k)
    FDA Class 2 ·Immunology

    M2376A DEVICELINK SYSTEM, MODEL M2376A

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    ERBE

    FDA Adverse Event
    Malfunction ·LEONHARD LANG GMBH·Product code GEI·November 2, 2022

    PRIME BIG WHEEL STRETCHER,30"

    FDA Adverse Event
    Malfunction ·STRYKER MEDICAL-KALAMAZOO·Product code FPO·April 2, 2013

    7900

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS GMBH·Product code JAA·March 7, 2011

    INFANT BIAS FLOW BREATHING CIRCUIT

    FDA Adverse Event
    Malfunction ·FISHER & PAYKEL HEALTHCARE, LTD.·Product code BTT·April 15, 2008

    ERBE

    FDA Adverse Event
    Malfunction ·LEONHARD LANG GMBH·Product code GEI·March 8, 2023

    ERBE

    FDA Adverse Event
    Malfunction ·LEONHARD LANG GMBH·Product code GEI·February 18, 2025

    ERBE

    FDA Adverse Event
    Injury ·LEONHARD LANG GMBH·Product code GEI·July 27, 2022

    PERCLOSE PROSTYLE SUTURE-MEDIATED CLOSURE AND REPAIR SYSTEM

    FDA Adverse Event
    Injury ·ABBOTT VASCULAR·Product code MGB·June 21, 2023

    LIFE SCOPE PT

    FDA Adverse Event
    Malfunction ·NIHON KOHDEN CORPORATION·Product code MHX·December 26, 2023

    LIFE SCOPE PT

    FDA Adverse Event
    Malfunction ·NIHON KOHDEN CORPORATION·Product code MHX·December 8, 2023

    Spirit Plus Bed, A-C Powered Hospital Bed

    FDA Enforcement
    Class II ·Terminated·CHG Hospital Beds Inc·August 10, 2016

    Spirit Select Bed, A-C Powered Hospital Bed

    FDA Enforcement
    Class II ·Terminated·CHG Hospital Beds Inc·August 10, 2016

    The Spirit Plus Bed, Model 5600 Spirit Plus /with high rail siderail option

    FDA Enforcement
    Class II ·Terminated·Stryker Medical Division of Stryker Corporation·November 21, 2018

    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