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

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    INTEL-GE CARE INNOVATIONS QUIETCARE

    FDA 510(k)
    FDA Class 1 ·General Hospital

    U&I, OPTIMA, SPINAL SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    K-Y BRAND LONG LASTING VAGINAL MOISTURIZER

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    EQUINOXE

    FDA Adverse Event
    Injury ·EXACTECH, INC.·Product code KWT·August 5, 2019

    EQUINOXE

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

    EQUINOXE

    FDA Adverse Event
    Injury ·EXACTECH, INC.·Product code KWT·February 5, 2019

    ACCU-CHEK ® SPIRIT COMBO

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code LZG·October 1, 2014

    PAINSMART

    FDA Adverse Event
    Malfunction ·MOOG DEVICE GROUP·Product code FRN·May 17, 2013

    CONCERTO CRT-D DR

    FDA Adverse Event
    Injury ·MEDTRONIC MED REL, INC.·Product code NIK·June 16, 2011

    WAVEWRITER ALPHA 16

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·November 24, 2023

    SPECIFIC DEVICE NOT REPORTED

    FDA Adverse Event
    Injury ·EXACTECH, INC.·Product code KWT·July 7, 2025

    TOSOH HLC-723G8 ANALYZER

    FDA Adverse Event
    Malfunction ·TOSOH CORPORATION·Product code LCP·December 20, 2017

    TOSOH HLC-723G8 ANALYZER

    FDA Adverse Event
    Malfunction ·TOSOH CORPORATION·Product code LCP·December 15, 2017

    TOSOH HLC-723G8 ANALYZER

    FDA Adverse Event
    Malfunction ·TOSOH CORPORATION·Product code LCP·December 20, 2017

    TOSOH HLC-723G8 ANALYZER

    FDA Adverse Event
    Malfunction ·TOSOH CORPORATION·Product code LCP·December 11, 2017

    G8

    FDA Adverse Event
    Malfunction ·TOSOH HI-TEC, INC.·Product code PDJ·August 27, 2025

    Exactech Equinoxe GLENOID,KEELED, CEMENTED, Mates with 38, 41, 44 head, alpha curvature, Sizes: a), Small, Item Number 314-01-02; b) Medium, Item number 314-01-03; c) Large, Item Number 314-01-04, Shoulder Arthroplasty

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·April 10, 2024