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

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    XLTEK LED GOGGLES, MODEL LED-01

    FDA 510(k)
    FDA Class 2 ·Neurology

    Henry Schein

    FDA UDI
    HENRY SCHEIN, INC.·00304040012215·Zirlux 16+ A3.5 95X20

    FOSTER GRANT

    FDA UDI
    FGX INTERNATIONAL INC.·00193033325421·

    FOSTER GRANT

    FDA UDI
    FGX INTERNATIONAL INC.·00193033325445·

    FOSTER GRANT

    FDA UDI
    FGX INTERNATIONAL INC.·00193033325414·

    FOSTER GRANT

    FDA UDI
    FGX INTERNATIONAL INC.·00193033325407·

    FOSTER GRANT

    FDA UDI
    FGX INTERNATIONAL INC.·00193033325452·

    FOSTER GRANT

    FDA UDI
    FGX INTERNATIONAL INC.·00193033325391·

    FOSTER GRANT

    FDA UDI
    FGX INTERNATIONAL INC.·00193033325438·

    BRIDGE III RECEIVER

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    EBI ANTERIOR CERVICAL PLATE SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    POWERED WHEELCHAIR

    FDA Adverse Event
    Malfunction ·INVACARE TAYLOR STREET·Product code ITI·March 19, 2013

    LEGEND XT 4CH COMBO PKG

    FDA Adverse Event
    Other ·Product code IPF·February 21, 2011

    FIRE STAR RX PTCA BALLOON CATHETER

    FDA Adverse Event
    Malfunction ·CORDIS DE MEXICO·Product code LOX·March 11, 2008

    VUELOCK SCREW, UNKNOWN SIZE

    FDA Adverse Event
    Injury ·ZIMMER BIOMET SPINE INC.·Product code KWQ·April 16, 2020

    VEULOCK SCREW, UNKNOWN SIZE

    FDA Adverse Event
    Injury ·ZIMMER BIOMET SPINE INC.·Product code KWQ·April 16, 2020

    VEULOCK SCREW, UNKNOWN SIZE

    FDA Adverse Event
    Injury ·ZIMMER BIOMET SPINE INC.·Product code KWQ·April 16, 2020

    VUELOCK PLATE, UNKNOWN SIZE

    FDA Adverse Event
    Injury ·ZIMMER BIOMET SPINE INC.·Product code KWQ·April 16, 2020

    VEULOCK SCREW, UNKNOWN SIZE

    FDA Adverse Event
    Injury ·ZIMMER BIOMET SPINE INC.·Product code KWQ·April 16, 2020

    Monitor with one Blood Parameter Module and one HSat Probe; 500AHCT Monitor with two Blood Parameter modules and one HSat Probe; 500AVHCT Product Usage: The CDI System 500 provides continuous, on-line monitoring of the extracorporeal partial pressure of oxygen and carbon dioxide, pH, potassium, oxygen saturation, hematocrit, hemoglobin and temperature. In addition, calculated values of base excess, bicarbonate, oxygen saturation, and oxygen consumption may also be provided. These parameters are displayed at either actual temperature or adjusted to 37¿C. For documentation purposes, the system 500s integral printer provides a hard copy of displayed parameters.

    FDA Enforcement
    Class II ·Terminated·Terumo Cardiovascular Systems Corporation·August 22, 2018