BEUDAMED
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    DIAGNOSTIC ELECTROMYOGRAPHY NEEDLE ELECTRODE, DISPOSABLE HYPODERMIC NEEDLE

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    Merit Medical®

    FDA UDI
    Merit Medical Systems, Inc.·00884450141410·

    D6-2 Ultrasonic Transducer(FDA)

    FDA UDI
    Shenzhen Mindray Bio-Medical Electronics Co., Ltd.·06944904088037·

    Genio System 2.1

    FDA UDI
    Nyxoah·05404031018693·The External Stimulator is a single-use, steril...

    LA PERSONAL SCOOTER

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    MODEL 4000 EEG MONITOR WITH PSI (PSA4000)

    FDA 510(k)
    FDA Class 2 ·Neurology

    AUTOSOFT 30

    FDA Adverse Event
    Malfunction ·UNOMEDICAL A/S·Product code FPA·June 7, 2024

    AUTOSOFT 30

    FDA Adverse Event
    Malfunction ·UNOMEDICAL A/S·Product code FPA·June 7, 2024

    9800

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·February 12, 2013

    FREESTYLE LITE

    FDA Adverse Event
    Malfunction ·Product code NBW·February 25, 2011

    RESTORE FEMORAL AIMER, 7MM OFFSET

    FDA Adverse Event
    Malfunction ·DEPUY MITEK·Product code NBH·February 25, 2008

    Boston Scientific/Cameron Health SQ-RX Model 1010 subcutaneous pulse generators. The S-ICD System is intended to provide therapy for the treatment of life-threatening ventricular tachyarrhythmias.

    FDA Enforcement
    Class II ·Terminated·Boston Scientific CRM Corp·March 27, 2013

    CADD-Solis Ambulatory Infusion Pumps, Model 2100. Intended for the following uses: Indicated for the following uses: Intra-arterial, subcutaneous, intraperitoneal, in close proximity to nerves, into an intraoperative site, epidural space or subarachnoid space. Therapies that require a continuous rate of infusion, intermittent bolus, and/or with patient-controlled demand doses.

    FDA Enforcement
    Class I ·Ongoing·Smiths Medical ASD Inc.·August 14, 2024

    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