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

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    VIDAS C. DIFFICILE TOXIN A&B (CDAB) ASSAY, MODEL: 30 118

    FDA 510(k)
    FDA Class 1 ·Microbiology

    PARADIGM SILHOUETTE, MODELS MMT-377, 378, 379, 380

    FDA 510(k)
    FDA Class 2 ·General Hospital

    MODIFICATION TO ACIS (AUTOMATED CELLULAR IMAGING SYSTEM)

    FDA 510(k)
    FDA Class 2 ·Hematology

    JTS UNIT

    FDA Adverse Event
    Malfunction ·STANMORE IMPLANTS WORLDWIDE·Product code KRO·September 11, 2018

    JTS COIL

    FDA Adverse Event
    Malfunction ·STANMORE IMPLANTS WORLDWIDE·Product code KRO·February 13, 2020

    JTS DRIVE UNIT SET

    FDA Adverse Event
    Malfunction ·STANMORE IMPLANTS WORLDWIDE·Product code KRO·March 6, 2023

    OT VERIO IQ METER

    FDA Adverse Event
    Injury ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·April 23, 2013

    ACCU-CHEK ® AVIVA TEST STRIPS

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code LFR·April 28, 2011

    CAPSURE SP

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO, INC.·Product code DTB·July 10, 2008

    JTS DRIVE UNIT SET

    FDA Adverse Event
    Malfunction ·STANMORE IMPLANTS WORLDWIDE·Product code KRO·March 15, 2022

    PROXIMAL TIBIA JTS (DISTAL FEMORAL COMPONENT)

    FDA Adverse Event
    Injury ·STANMORE IMPLANTS WORLDWIDE·Product code KRO·November 28, 2018

    JTS DRIVE UNIT

    FDA Adverse Event
    Malfunction ·STANMORE IMPLANTS WORLDWIDE·Product code KRO·November 21, 2019

    JTS DRIVE UNIT SET

    FDA Adverse Event
    Malfunction ·STANMORE IMPLANTS WORLDWIDE·Product code KRO·May 27, 2022

    JTS EXTENDIBLE DISTAL FEMORAL IMPLANT

    FDA Adverse Event
    Injury ·STANMORE IMPLANTS WORLDWIDE LTD·Product code KRO·July 24, 2014

    JTS DRIVE UNIT

    FDA Adverse Event
    Malfunction ·STANMORE IMPLANTS WORLDWIDE·Product code KRO·April 8, 2020

    JTS DRIVE UNIT

    FDA Adverse Event
    Malfunction ·STANMORE IMPLANTS WORLDWIDE·Product code KRO·June 29, 2020

    CUSTOM PROXIMAL FEMUR JTS REPLACEMENT IMPLANT

    FDA Adverse Event
    Malfunction ·STANMORE IMPLANTS WORLDWIDE LTD.·Product code KRO·June 25, 2015

    DISTAL FEMUR JTS

    FDA Adverse Event
    Injury ·STANMORE IMPLANTS WORLDWIDE·Product code KRO·July 18, 2019

    JTS DRIVE UNIT SET

    FDA Adverse Event
    Malfunction ·STANMORE IMPLANTS WORLDWIDE·Product code KRO·April 28, 2022

    Stryker MA204 Bed Model (FL25E) Beds are intended for medical purposes in both general patient care as well as critical care environments. Each uses built-in electric motors and controls which can be operated by the patient, or caregiver, to adjust the height and/or surface contour of the bed.The devices listed above also include movable and latchable side rails which can be lowered or raised to help prevent patient fall and subsequent injury. The Beds include an optional Scale (Models: FL20E, FL25E, FL28C, FL28EX) as well as an optional Bed Exit (1 Zone) or Chaperone

    FDA Enforcement
    Class II ·Terminated·Stryker Medical Division of Stryker Corporation·July 4, 2012