BEUDAMED
    8 results · 19ms · Sources: EU EUDAMED, US FDA

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    ENDOCAM CAMERA SYSTEMS 5502/5507 WITH CR CAMERA HEADS AND ACCESSORIES

    FDA 510(k)
    FDA Class 1 ·General, Plastic Surgery

    SYNCHRON CREATINE KINASE REAGENT

    FDA Adverse Event
    BECKMAN COULTER INC.·Product code CGS·June 17, 2011

    DS-A BLOOD GLUCOSE MONITORING SYSTEM

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    BL-Cart IOL Delivery Cartridge

    FDA 510(k)
    FDA Class 1 ·Ophthalmic

    VIPER CORTICAL FIXATION,POLYAXIAL SCREW, 5.5 TI 8X45MM

    FDA Adverse Event
    Malfunction ·DEPUY SYNTHES SPINE·Product code NKB·February 28, 2013

    TRILOGY 100

    FDA Adverse Event
    Malfunction ·RESPIRONICS INC.,·Product code CBK·July 2, 2014

    KII BALLOON BLUNT TIP SYSTEM

    FDA Adverse Event
    Malfunction ·APPLIED MEDICAL·Product code GCJ·September 28, 2016

    Assurity Model Numbers: PM1240, PM2240; Assurity + Model Number: PM2260; Accent Model Numbers: PM1210, PM2210, PM1222, PM2212; Accent MRI Model Numbers: PM1224, PM2218, PM2224 Implantation of a single-chamber pulse generator, dual-chamber pulse generator, or CRT-P is indicated in one or more of the following permanent conditions: Syncope, Presyncope, Fatigue, Disorientation, Or any combination of those symptoms. Implantation of a CRT-P is indicated for: Maintaining synchrony of the left and right ventricles in patients who have undergone an AV nodal ablation for chronic atrial fibrillation and have NYHA Class II or III heart failure. The reduction of the symptoms of moderate to severe heart failure (NYHA Class III or IV) in those patients who remain symptomatic despite stable, optimal medical therapy, and have a left ventricular ejection fraction d35% and a prolonged QRS duration

    FDA Enforcement
    Class II ·Terminated·St Jude Medical Inc.·October 25, 2017