BEUDAMED
    1,094 results · 24ms · Sources: EU EUDAMED, US FDA

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    EXACTECH EQUINOXE SHOULDER SYSTEM TORQUE DEFINING SCREW AND SHORT REPLICATOR PLATE

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    EQUINOXE

    FDA Adverse Event
    Injury ·EXACTECH, INC.·Product code KWT·February 6, 2019

    AF541

    FDA UDI
    Respironics, Inc.·00606959024533·AF541 Mask with Entrainment Elbow, Leak 2, with...

    JIE+HONG MEDICAL SURGICAL GOWNS - STERILE, JIE+HONG MEDICAL SURGICAL GOWNS - NON STERILE

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

    SURESIGNS VM4, SURESIGNS VM6, SURESIGNS VM8 MODEL: 863063, 863064, 863065, 863066, 863068

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    ENTERRA

    FDA Adverse Event
    Injury ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LNQ·May 20, 2013

    ALLEGRETTO WAVE EYE-Q

    FDA Adverse Event
    Injury ·WAVELIGHT GMBH·Product code LZS·September 24, 2014

    LENSX LASER SYSTEM

    FDA Adverse Event
    Injury ·ALCON - LENSX LASERS, INC.·Product code OOE·June 9, 2011

    UNKNOWN

    FDA Adverse Event
    Injury ·WILLIAM COOK EUROPE·Product code DTK·May 20, 2016

    Invue Split Driver, Assembly with Handle, Model SI70006 Rev G. Used in conjunction with the Invue Anterior Cervical Plate System under 501(k) clearance number K121060. The Invue Driver is an instrument consisting of a Radel handle, a shaft and hexalobe-like tip with a 4.0mm split, which allows the driver to collapse to fit into a screw and expand to retain the screw.

    FDA Enforcement
    Class II ·Terminated·SpineFrontier, Inc.·August 14, 2013

    GUNTHER TULIP JUGULAR & FEMORAL VENA CAVA FILTER SET

    FDA Adverse Event
    Injury ·COOK INC·Product code DTK·February 9, 2017

    GUNTHER TULIP FEMORAL VENA CAVA FILTER SET

    FDA Adverse Event
    Injury ·COOK INC·Product code DTK·June 3, 2016

    UNKNOWN

    FDA Adverse Event
    Injury ·WILLIAM COOK EUROPE·Product code DTK·January 5, 2017

    GUNTHER TULIP JUGULAR VENA CAVA FILTER SET

    FDA Adverse Event
    Injury ·COOK INC·Product code DTK·November 8, 2016

    GUNTHER TULIP FEMORAL VENA CAVA FILTER SET

    FDA Adverse Event
    Injury ·COOK INC·Product code DTK·November 15, 2016

    GUNTHER TULIP FEMORAL VENA CAVA FILTER SET

    FDA Adverse Event
    Injury ·COOK INC·Product code DTK·February 25, 2016

    GUNTHER TULIP JUGULAR VENA CAVA FILTER SET

    FDA Adverse Event
    Injury ·COOK INC·Product code DTK·September 29, 2016

    UNKNOWN

    FDA Adverse Event
    Injury ·WILLIAM COOK EUROPE·Product code DTK·July 18, 2016

    UNKNOWN

    FDA Adverse Event
    Malfunction ·WILLIAM COOK EUROPE·Product code DTK·December 15, 2015

    UNKNOWN

    FDA Adverse Event
    Malfunction ·WILLIAM COOK EUROPE·Product code DTK·November 19, 2015