BEUDAMED
    10 results · 29ms · Sources: EU EUDAMED, US FDA

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    QUANTA Flash HMGCR Reagents

    FDA 510(k)
    FDA Class 2 ·Immunology

    BOSS Instruments

    FDA UDI
    BOSS INSTRUMENTS, LTD., INC.·00888515023963·Ribbon Retractor, 2 1/2" width, 13"

    FENCER 308 EXCIMER LASER SYSTEM

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

    NITRIL EXAM GLOVE, PRE-POWERED COLOR WHITE, NITRILE EXAM GLOVE, PRE-POWDERED, COLOR BLUE

    FDA 510(k)
    FDA Class 1 ·General Hospital

    HANDLE-SM W/HEX-COUPLE

    FDA Adverse Event
    Malfunction ·SYNTHES GMBH·Product code HXX·December 2, 2021

    SYSTEM, PERITONEAL, AUTOMATIC DELIVERY

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·October 17, 2014

    SYNCHROMED II

    FDA Adverse Event
    Injury ·MDT PUERTO RICO OPERATIONS CO., JUNCOS·Product code LKK·July 22, 2011

    MECHANICAL WALKER, ROLLATOR

    FDA Adverse Event
    Malfunction ·UNKNOWN·Product code ITJ·June 20, 2013

    HAND PIECE FOR BATTERY POWERED DRIVER

    FDA Adverse Event
    Malfunction ·SYNTHES MONUMENT·Product code HXX·July 15, 2015

    Boston Scientific COGNIS CRT-D, Cardiac Resynchronization Therapy Defibrillator, models N118, N119. The following models are not available in the US: models N106, N107, P106, P107. Sterilized using ethylene oxide. Product Usage: Boston Scientific cardiac resynchronization therapy defibrillators (CRT-Ds) are indicated for patients with moderate to severe heart failure who remain symptomatic despite stable, optimal heart failure drug therapy and have left ventricular dysfunction and QRS duration > or equal to 120 ms. This family of pulse generators provide a variety of therapies including: -Ventricular tachyarrhythmia therapy, which is used to treat rhythms associated with sudden cardiac death such as VT and VF; -Cardiac Resynchronization Therapy (CRT), which treats heart failure by resynchronizing ventricular contractions through biventricular electrical stimulation; -Bradycardia pacing, including adaptive rate pacing, to detect and treat bradyarrhythmias and to provide cardiac rate support after defibrillation therapy.

    FDA Enforcement
    Class II ·Terminated·Boston Scientific CRM Corp·October 29, 2014