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

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    HI-TORQUE BALANCE

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    PEAK PLASMABLADE PLUS TISSUE DISSECTION DEVICE

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

    POWDER FREE LATEX EXAMINATION GLOVES, SIZES SMALL, MEDIUM, LARGE, X-LARGE

    FDA 510(k)
    FDA Class 1 ·General Hospital

    VERSACROSS CONNECT LAAC ACCESS SOLUTION

    FDA Adverse Event
    Injury ·BAYLIS MEDICAL COMPANY INC.·Product code DRE·April 6, 2023

    COCR BALL HEAD 12/14 Ø 22 SIZE M 0

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code JDI·October 26, 2018

    PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)

    FDA Adverse Event
    Malfunction ·INVACARE FLORIDA OPERATIONS·Product code CAW·October 8, 2014

    ATTAIN OTW

    FDA Adverse Event
    Injury ·MPRI·Product code LWP·June 7, 2013

    STENOSCOP

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·June 24, 2011

    VERSACROSS ACCESS SOLUTION

    FDA Adverse Event
    Injury ·BAYLIS MEDICAL COMPANY INC.·Product code DXF·April 19, 2023

    RESTORE ADVANCED

    FDA Adverse Event
    Injury ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·September 25, 2014

    VERSACROSS ACCESS SOLUTION

    FDA Adverse Event
    Injury ·BAYLIS MEDICAL COMPANY INC.·Product code DYB·April 20, 2023

    VERSACROSS CONNECT LAAC ACCESS SOLUTION

    FDA Adverse Event
    Injury ·BAYLIS MEDICAL COMPANY INC.·Product code DXF·April 25, 2023

    VITROS CHEMISTRY PRODUCTS OP REAGENT

    FDA Adverse Event
    Malfunction ·ORTHO-CLINICAL DIAGNOSTICS·Product code DJG·June 27, 2017

    ELEKTA LIMITED Elekta Infinity, REF XRT 0511, XRT 0521, XRT 0531, XRT 0541; Medical Charged-Particle Radiation Therapy System Accelerator, Linear

    FDA Enforcement
    Class II ·Ongoing·Elekta, Inc.·December 13, 2023

    GXL acetabular liners, orthopedic hip implant component. Product Line Numbers: a. NOVATION CONSTRAINED LINER 28MM ID GROUP 1, REF 134-28-41 b. NOVATION CONSTRAINED LINER 32MM ID GROUP 2, REF 134-32-42 c. NOVATION CONSTRAINED LINER 36MM ID GROUP 3, REF 134-36-43 d. NOVATION CONSTRAINED LINER 36MM ID GROUP 4, REF 134-36-44 e. NOVATION CONSTRAINED LINER 36MM ID GROUP 5, REF 134-36-45

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·September 21, 2022