BEUDAMED
    11 results · 20ms · Sources: EU EUDAMED, US FDA

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    Full Automatic (NIBP) Blood Pressure Monitor-HL158TB

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Integra® Jarit®

    FDA UDI
    INTEGRA LIFESCIENCES PRODUCTION CORPORATION·10381780181903·Integra® Jarit® Meyerding Finger Retractor, 7",...

    Marina Medical

    FDA UDI
    MARINA MEDICAL INSTRUMENTS, INC.·00840306822001·Feilchenfeld Splinter Forceps, 12cm

    CETRA

    FDA UDI
    Orthofix US LLC·18257200120369·1-LEVEL PLATE ASSEMBLY, 34MM

    INTRAVENOUS POWER INJECTOR EXTENSION SET

    FDA 510(k)
    FDA Class 2 ·General Hospital

    NC TREK RX CORONARY DILATATION CATHETER

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    CORIN OPTIMIZED POSITIONING SYSTEM

    FDA Adverse Event
    Injury ·OPTIMIZED ORTHO PTY LTD·Product code LZO·December 2, 2019

    SJM MECHANICAL HEART VALVE HEMODYNAMIC PLUS

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL·Product code LWQ·June 21, 2013

    COLLEAGUE PRE P1.7

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·August 4, 2011

    PROMUS ELEMENT ?

    FDA Adverse Event
    Death ·BOSTON SCIENTIFIC - GALWAY·Product code NIQ·October 21, 2014

    This correction applies to all GE Healthcare MRI systems with superconducting magnets: Discovery MR450, Discovery MR750, Signa HDx, Signa HDxt, Signa HDi, GE 1.5T Signa HDe, Optima MR360, Brivo MR355, Signa Excite-HD 1.5T & 3T, Signa Excite 1.5T HD Twinspeed, Signa Excite 1.5T HD Echospeed, Signa Excite 1.5T HD Highspeed, 1.5T Signa Infinity TwinSpeed , 1.5T Signa Infinity EchoSpeed Plus, 1.5T Signa Infinity HiSpeed Plus, 1.0T Signa Infinity HiSpeed Plus. 1.0T Signa Infinity SmartSpeed, Signa EXCITE 3.0T, Signa EXCITE 3.0T HD, Signa Excite 1.5T TwinSpeed, Signa Excite 1.5T EchoSpeed, Signa Excite 1.5T HiSpeed, Signa Excite 1.5T SmartSpeed, Signa Excite 1.5T, Signa Excite 3.0T, Signa Contour/I, Signa OpenSpeed, Vectra, MR Max, Optima MR450w GEM, Discovery MR750W GEM, Optima MR450w. Product Usage: Magnetic resonance (MR) diagnostic devices are intended for producing images of the internal structures of the body based on the spatial distribution of molecules exhibiting magnetic resonance. Most MR systems are intended for diagnostic use.

    FDA Enforcement
    Class I ·Terminated·GE Healthcare·February 25, 2015