BEUDAMED
    10 results · 27ms · Sources: EU EUDAMED, US FDA

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    SILHOUETTE VR

    FDA 510(k)
    FDA Class 2 ·Radiology

    SYNCHRON CREATINE KINASE REAGENT

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

    ETHICON ENDO-SURGERY ARTICULATING HOOK KNIFE, MODEL IN4505

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

    EZStart Interference Screw

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    ADVIA CENTAUR TOTAL HCG (THCG) AND PROGESTERONE

    FDA Adverse Event
    Other ·SIEMENS HEALTHCARE DIAGNOSTICS INC.·Product code JHI·March 5, 2010

    1.8MM DRILL BIT

    FDA Adverse Event
    Malfunction ·SYNTHES (USA) MONUMENT·Product code HTW·February 26, 2013

    MD - DISPOSABLE

    FDA Adverse Event
    Malfunction ·UNKNOWN MANUFACTURING FACILITY·Product code FPA·February 9, 2011

    TRILOGY 100

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

    Exactech Equinoxe REVERSE SHOULDER,42mm Constrained Humeral Liner, a) +0mm, Item number 320-42-10, b) +2.5mm, Item Number 320-42-13; Shoulder Arthroplasty

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·April 10, 2024

    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