BEUDAMED
    18 results · 21ms · Sources: EU EUDAMED, US FDA

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    Full Automatic (NIBP) Blood Pressure Monitor

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    DIVERGENCE-L™ Anterior/Oblique Lumbar Fusion System

    FDA UDI
    MEDTRONIC SOFAMOR DANEK, INC.·00643169501928·NTERBODY 2153214 MEDIUM - 18 DEG 14MM

    MEDI

    FDA UDI
    MEDI MANUFACTURING, INC.·04051526550193·GENUMEDI PT KNEE SUP SILVER R EW IV

    MEDI

    FDA UDI
    MEDI MANUFACTURING, INC.·04049772814770·GENUMEDI EXTRA WIDE SILVER SIZE IV

    Bard® Urine Meter with Bag

    FDA UDI
    C. R. Bard, Inc.·00801741033148·Bard® Urine Meter with Bag

    I-STAT EC8+ CARTRIDGE

    FDA Adverse Event
    Malfunction ·ABBOTT POINT OF CARE·Product code CHL·October 9, 2017

    M3810A PHILIPS TELEMONITORING SYSTEM WITH EDEVICE BRIDGED130

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    THERAKNIT GARMENT ELECTRODE

    FDA 510(k)
    FDA Class 2 ·Neurology

    PIVOX¿ OBLIQUE LATERAL SPINAL SYSTEM

    FDA Adverse Event
    Injury ·MEDTRONIC SOFAMOR DANEK·Product code MAX·April 29, 2016

    OT VERIO FLEX METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·April 1, 2015

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·October 8, 2014

    PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE

    FDA Adverse Event
    Malfunction ·MEDTRONIC, INC.·Product code LWP·June 8, 2013

    TALENT THORACIC STENT GRAFT

    FDA Adverse Event
    Injury ·MEDTRONIC CARDIOVASCULAR·Product code MIH·June 23, 2011

    Artis zee biplane, Model Number 10094141

    FDA Enforcement
    Class II ·Terminated·Siemens Medical Solutions USA, Inc·July 31, 2019

    ELEKTA LIMITED Precise Digital Accelerator, REF MRT 6001, MRT 6011; Medical Charged-Particle Radiation Therapy System Accelerator, Linear

    FDA Enforcement
    Class II ·Ongoing·Elekta, Inc.·December 13, 2023

    Artis zee/ zeego systems; dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients.

    FDA Enforcement
    Class II ·Terminated·Siemens Medical Solutions USA, Inc·August 26, 2015

    The Artis zee / zeego Angiography System is designed as a set of components that may be combined into different configurations to provide specialized angiography systems.

    FDA Enforcement
    Class II ·Terminated·Siemens Medical Solutions USA, Inc·December 10, 2014

    Siemens Artis zee systems; dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients. Procedures that can be performed include cardiac angiography, neuro angiography, general angiography, rotational angiography, multipurpose angiography and whole body radiographic/fluoroscopic procedures.

    FDA Enforcement
    Class II ·Terminated·Siemens Medical Solutions USA, Inc·August 12, 2015