BEUDAMED
    19 results · 28ms · Sources: EU EUDAMED, US FDA

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    CLEARPATH

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    SW

    FDA UDI
    SW SAFETY SOLUTIONS INC.·00616489112853·TrueForm Nitrile Exam Gloves, Extra Large

    N/A

    FDA UDI
    TETRA MEDICAL SUPPLY CORP.·00614138125247·SUSPENSORY SUPPORT W/LEG STRAPS XXLARGE

    LEONE SPA

    FDA UDI
    LEONE SPA·08033707065753·INTRAORAL ELASTICS 6,5 oz 5/16" blue

    Merit Medical®

    FDA UDI
    Merit Medical Systems, Inc.·00884450270523·

    Merit Medical®

    FDA UDI
    Merit Medical Systems, Inc.·00884450409176·

    Merit Medical®

    FDA UDI
    Merit Medical Systems, Inc.·00884450409183·

    ZOLL MFC

    FDA UDI
    Zoll Medical Corporation·00847946018320·

    MICROLIFE WRIST WATCH BLOOD PRESSURE, MODEL BP-3BU1-5, WITH OPTIONAL THERMAL PRINTER

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    MAC-LAB SYSTEM AND CARDIOLAB EP SYSTEM

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    VERTEX RECONSTRUCTION SYSTEM

    FDA Adverse Event
    Injury ·WARSAW ORTHOPEDICS·Product code KWP·January 9, 2014

    UNKNOWN_NEUROVASCULAR_PRODUCT

    FDA Adverse Event
    Injury ·CONCENTRIC MEDICAL·Product code NRY·December 14, 2012

    LIFEPAK CR PLUS DEFIBRILLATOR

    FDA Adverse Event
    Malfunction ·PHYSIO-CONTROL, INC.·Product code MKJ·May 4, 2011

    ACCUTORR V MONITOR

    FDA Adverse Event
    Malfunction ·MINDRAY DS USA, INC.·Product code MHX·April 30, 2013

    PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)

    FDA Adverse Event
    Malfunction ·INVACARE FLORIDA OPERATIONS·Product code CAW·September 16, 2014

    VITROS Immunodiagnostic Products TOTAL T4 REAGENT PACK, Ref #874 4468, 100 coated wells. Firm on label: Ortho-Clinical Diagnostics, Amersham UK.

    FDA Recall
    Terminated ·Ortho-Clinical Diagnostics·Product code KLI·March 15, 2005

    Custom Fluid Management Set, Sterile, EO, Rx Only Used to transfer contrast media and saline from a container to a patients vascular system.

    FDA Enforcement
    Class II ·Terminated·Merit Medical Systems, Inc.·November 30, 2016

    Micropuncture Check-Flo Performer Introducer Set, Individual product is packaged in a Tyvek-film sterilizable outer pouch. Introducers are intended for introduction of balloons, closed and non-tapered end catheters or other diagnostic and interventional devices

    FDA Enforcement
    Class II ·Terminated·Cook Inc.·March 8, 2017

    Medtronic MiniMed(TM) Mio(TM) (MMT-921, 921T, 923, 923T, 925, 925T, 941, 941T, 943, 943T, 945, 945T, 961, 963, 963T, 965, 965T, 975, 975T)

    FDA Enforcement
    Class II ·Ongoing·Medtronic Inc.·November 29, 2017