BEUDAMED
    9 results · 35ms · Sources: EU EUDAMED, US FDA

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    IS ANTI-TPO IGG ELISA TEST SYSTEM

    FDA 510(k)
    FDA Class 2 ·Immunology

    Polystar HK

    FDA UDI
    Merz Dental GmbH·D7091984228·anteriors; shade B1; mould O 48

    KRONNER SPHERICAL CUTTERS

    FDA 510(k)
    FDA Class 1 ·Orthopedic

    CDI(R) 2000 BLOOD GAS MONITOR

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    RIATA PASSIVE FIXATION

    FDA Adverse Event
    Malfunction ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code NVY·February 28, 2013

    MULTI-LINK RX VISION CORONARY STENT SYSTEM

    FDA Adverse Event
    Injury ·AV-TEMECULA-CT·Product code MAF·February 10, 2011

    XMAX MOTOR

    FDA Adverse Event
    Malfunction ·DEPUY SYNTHES POWER TOOLS·Product code ERL·December 18, 2013

    Synthes Sciatic Nerve Retractor and Sciatic Nerve Retractor Long; Synthes Sciatic Nerve Retractor and Sciatic Nerve Retractor Long are system specific instruments to the 3.5 mm Low Profile Pelvic System Retractor Set.

    FDA Enforcement
    Class II ·Terminated·Synthes (USA) Products LLC·August 26, 2015

    Anthem Model Numbers: PM3210, PM3212; Allure/Relieve Model Numbers: PM3222, PM3242, PM3262, PM3542, PM3224, PM3244 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