BEUDAMED
    21 results · 39ms · Sources: EU EUDAMED, US FDA

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    EVOKE CLOSED LOOP STIMULATOR (CLS)

    FDA Adverse Event
    Injury ·SALUDA MEDICAL PTY LTD·Product code LGW·February 26, 2026

    CFS02, 5X100 KII SLEEVE ADVFIX 12/BX

    FDA Adverse Event
    Malfunction ·APPLIED MEDICAL RESOURCES·Product code GCJ·August 3, 2022

    EVOKE CLOSED LOOP STIMULATOR (CLS) (US)

    FDA Adverse Event
    Injury ·SALUDA MEDICAL PTY LTD·Product code LGW·October 28, 2025

    EVOKE CLOSED LOOP STIMULATOR (CLS)

    FDA Adverse Event
    Injury ·SALUDA MEDICAL PTY LTD·Product code LGW·July 8, 2025

    EVOKE CLOSED LOOP STIMULATOR (CLS)

    FDA Adverse Event
    Injury ·SALUDA MEDICAL PTY LTD·Product code LGW·April 28, 2025

    CFS02, 5X100 KII SLEEVE ADVFIX 12/BX

    FDA Adverse Event
    Malfunction ·APPLIED MEDICAL RESOURCES·Product code GCJ·August 3, 2022

    LIGHTHEAD F628

    FDA Adverse Event
    Malfunction ·BERCHTOLD GMBH & CO. KG·Product code FSY·August 12, 2025

    EVOKE 12C PERCUTANEOUS LEAD KIT - 60CM

    FDA Adverse Event
    Injury ·SALUDA MEDICAL PTY LTD·Product code LGW·September 25, 2024

    EVOKE CLOSED LOOP STIMULATOR (CLS)

    FDA Adverse Event
    Injury ·SALUDA MEDICAL PTY LTD·Product code LGW·April 29, 2026

    EVOKE CLOSED LOOP STIMULATOR (CLS)

    FDA Adverse Event
    Injury ·SALUDA MEDICAL PTY LTD·Product code LGW·April 1, 2026

    SCULPTRA

    FDA Adverse Event
    GLOBAL PHARMACOVIGILANCE AND EPIDEMIOLOGY/SANOFI-AVENTIS·Product code LMH·December 21, 2009

    EVOKE CLOSED LOOP STIMULATOR (CLS)

    FDA Adverse Event
    Injury ·SALUDA MEDICAL PTY LTD·Product code LGW·November 25, 2025

    EVOKE CLOSED LOOP STIMULATOR (CLS)

    FDA Adverse Event
    Injury ·SALUDA MEDICAL PTY LTD·Product code LGW·August 8, 2025

    EVOKE CLOSED LOOP STIMULATOR (CLS) (US)

    FDA Adverse Event
    Injury ·SALUDA MEDICAL PTY LTD·Product code LGW·October 15, 2025

    EVOKE CLOSED LOOP STIMULATOR (CLS)

    FDA Adverse Event
    Injury ·SALUDA MEDICAL PTY LTD·Product code LGW·March 6, 2026

    EVOLUT R TRANSCATHETER AORTIC VALVE

    FDA Adverse Event
    Injury ·MEDTRONIC HEART VALVES DIVISION·Product code NPT·July 8, 2021

    EVOKE 12C PERCUTANEOUS LEAD KIT - 60CM

    FDA Adverse Event
    Injury ·SALUDA MEDICAL PTY LTD·Product code LGW·December 15, 2024

    Brand Name: ZOLL Product Name: Powerheart G5 AED Model/Catalog Number: (1) G5S-01C, (2) G5S-02C, (3) G5S-10C, (4) G5S-11C; Software Version: NA Product Description: The Powerheart G5 automated external defibrillator (AED) is designed for treating life-threatening heart beat irregularities, such as ventricular fibrillation, that cause Sudden Cardiac Arrest (SCA). There are two models available fully automatic and semi-automatic. After the defibrillations pads are applied to the patient, the fully automatic model evaluates the heart rhythm and, if a shockable rhythm is detected, delivers a shock without any rescuer assistance. The semi-automatic model evaluates the heart rhythm and requires the rescuer to press the shock button if a shockable rhythm is detected. Both models have voice and text instructions that guide the rescuer through the entire defibrillation process. Note: Not all configurations described in this document are available in all areas.

    FDA Enforcement
    Class II ·Ongoing·ZOLL Medical Corporation·March 19, 2025

    Brand Name: ZOLL Product Name: Powerheart G5 AED Model/Catalog Number: (1) G5A-01C, (2) G5A-02C, (3) G5A-05C, (4) G5A-08C, (5) G5A-10C, (6) G5A-13C, (7) G5A-15C, (8) G5A-22C, (9) G5A-41C, (10) G5A-85C, (11) G5A-90C (12) G5A-80-L; Software Version: NA Product Description: The Powerheart G5 automated external defibrillator (AED) is designed for treating life-threatening heart beat irregularities, such as ventricular fibrillation, that cause Sudden Cardiac Arrest (SCA). There are two models available fully automatic and semi-automatic. After the defibrillations pads are applied to the patient, the fully automatic model evaluates the heart rhythm and, if a shockable rhythm is detected, delivers a shock without any rescuer assistance. The semi-automatic model evaluates the heart rhythm and requires the rescuer to press the shock button if a shockable rhythm is detected. Both models have voice and text instructions that guide the rescuer through the entire defibrillation process. Note: Not all configurations described in this document are available in all areas.

    FDA Recall
    Open, Classified ·ZOLL Medical Corporation·Product code MKJ·February 13, 2025

    Brand Name: ZOLL Product Name: Powerheart G5 AED Model/Catalog Number: (1) G5A-01C, (2) G5A-02C, (3) G5A-05C, (4) G5A-08C, (5) G5A-10C, (6) G5A-13C, (7) G5A-15C, (8) G5A-22C, (9) G5A-41C, (10) G5A-85C, (11) G5A-90C (12) G5A-80-L; Software Version: NA Product Description: The Powerheart G5 automated external defibrillator (AED) is designed for treating life-threatening heart beat irregularities, such as ventricular fibrillation, that cause Sudden Cardiac Arrest (SCA). There are two models available fully automatic and semi-automatic. After the defibrillations pads are applied to the patient, the fully automatic model evaluates the heart rhythm and, if a shockable rhythm is detected, delivers a shock without any rescuer assistance. The semi-automatic model evaluates the heart rhythm and requires the rescuer to press the shock button if a shockable rhythm is detected. Both models have voice and text instructions that guide the rescuer through the entire defibrillation process. Note: Not all configurations described in this document are available in all areas.

    FDA Enforcement
    Class II ·Ongoing·ZOLL Medical Corporation·March 19, 2025