BEUDAMED
    29 results · 26ms · Sources: EU EUDAMED, US FDA

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    U2 TOTAL KNEE SYSTEM - PSA TYPE, OFFSET STEM ADAPTER

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    K121116

    FDA UDI
    Life Spine, Inc.·00190837016029·

    Plateau-X Spacer System

    FDA UDI
    Life Spine, Inc.·00190837016043·

    Plateau-X Spacer System

    FDA UDI
    Life Spine, Inc.·00190837016258·

    Kitazato IUI Catheter

    FDA UDI
    KITAZATO CORPORATION·04580745041224·

    TALOS® HA PEEK IBF

    FDA UDI
    MEDITECH SPINE, LLC·B167321311160·

    3.5MM CORTEX SCREW SELF-TAPPING 55MM

    FDA Adverse Event
    Injury ·SYNTHES MONUMENT·Product code HWC·January 26, 2017

    SCREW, FIXATION, BONE

    FDA Adverse Event
    Injury ·WRIGHTS LANE SYNTHES USA PRODUCTS LLC·Product code HWC·July 25, 2018

    HI-TORQUE PILOT 50 AND 150 GUIDE WIRE WITH HYDROCOAT HYDROPHILIC COATING, HI-TORQUE WHISPER LS AND MS GUIDE WIRE WITH

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    VECTRA (INTELECT) EPR ULTRASOUND

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    SCREW, FIXATION, BONE

    FDA Adverse Event
    Injury ·SYNTHES USA·Product code HWC·November 18, 2015

    Widex

    FDA UDI
    Widex A/S·05706069886344·WIDEX MOMENT MRB0 (Dark cherry ) 330, RIC 10

    SCREW, FIXATION, BONE

    FDA Adverse Event
    Injury ·WRIGHTS LANE SYNTHES USA PRODUCTS LLC·Product code HWC·June 7, 2018

    Back up batteries in Ventilators labeled as the following: a. CARESCAPE R860 Ventilators (K142679) b. ENGSTROM (K111116) c. ENGSTROM Carestation (K111116) d. ENGSTROM PRO (K111116)

    FDA Recall
    Open, Classified ·GE Healthcare, LLC·Product code CBK·April 18, 2022

    Back up batteries in Ventilators labeled as the following: a. CARESCAPE R860 Ventilators (K142679) b. ENGSTROM (K111116) c. ENGSTROM Carestation (K111116) d. ENGSTROM PRO (K111116)

    FDA Enforcement
    Class I ·Ongoing·GE Healthcare, LLC·June 15, 2022

    DIGITAL RADIOGRAPHY CXDI

    FDA Adverse Event
    Malfunction ·CANON, INC.·Product code MQB·December 22, 2019

    DIGITAL RADIOGRAPHY CXDI

    FDA Adverse Event
    Malfunction ·CANON, INC.·Product code MQB·December 22, 2019

    DIGITAL RADIOGRAPHY CXDI

    FDA Adverse Event
    Malfunction ·CANON, INC.·Product code MQB·December 22, 2019

    3.5MM CORTEX SCREW SELF-TAPPING 16MM

    FDA Adverse Event
    Injury ·SYNTHES USA·Product code HWC·January 6, 2016

    3.5MM CORTEX SCREW SELF-TAPPING 14MM

    FDA Adverse Event
    Injury ·SYNTHES USA·Product code HWC·January 6, 2016