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

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    ROCHE SERUM CONTROL NORMAL (HUMAN), ROCHE SERUM CONTROL PATHOLOGICAL (HUMAN)

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    artegral

    FDA UDI
    Merz Dental GmbH·D7091972214·posteriors; shade A3 light; size M; upper jaw

    Modified Winch Kyphoplasty (15 and 20 mm) 11 Gauge Balloon Catheters

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    PORTABLE VENTILATOR, MODEL EPV-100

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    MIRAGE .008" HYDROPHYLIC GUIDEWIRE

    FDA Adverse Event
    Injury ·EV3 NEUROVASCULAR·Product code DQX·February 21, 2013

    NOVASURE IMPEDANCE CONTROLLED EA SYSTEM

    FDA Adverse Event
    Injury ·HOLOGIC·Product code MNB·January 19, 2011

    DEPUY ASR XL FEM IMP SIZE 53

    FDA Adverse Event
    Injury ·DEPUY INTERNATIONAL LTD. 8010379·Product code KXA·July 31, 2014

    Welch Allyn AED 20 Automated External Defibrillator; a portable, 12V internal battery powered defibrillator; Manufactured by MRL Inc., A Welch Allyn Company, Buffalo Grove, Illinois; Model AED 20, Catalog Numbers 972213, 972214, 972215, 972216 (Part Numbers 972200E, 972211E, 972212E, 972213E, 972214E, 972215E, 972216E)

    FDA Recall
    Terminated ·Welch Allyn Protocol, Inc·Product code MKJ·August 23, 2007

    Model 055: Thermophore Classic, Professional Quality, Deep-Heat Therapy, Model 055 Large 14' x 27", Model 056: Thermophore Classic, Professional Quality Deep-Heat Therapy, Model 056 Medium 14" x 14", Model 077: Thermophore Classic Professional Quality Deep-Heat Therapy, Model 077 Petite 4"x 17",Model 095: Thermophore Classic, Professional Quality Deep-Heat Therapy, Model 095 Large 14" x 27 Model 096: Thermophore Classic, Professional Quality Deep-Heat therapy Model 096, Medium, 14" x 14" Model 097: Thermophore Classic, Professional quality Deep-Heat Therapy, Model 097 , Petite, 4" x 17", Model 255: Thermophore Classic Plus, Professional Quality Deep-Heat Therapy, Model 255 Large,14" x 27", Model 256: Thermophore Classic Plus Professional Quality Deep-Heat Therapy, Model 256, Medium, 14" X 14 Model 277: Thermophore Classic Plus Professional Quality Deep-Heat Therapy, Model 277, Petite , 4" x 17" Used for the temporary relief of joint and muscle pain.

    FDA Enforcement
    Class II ·Terminated·Battle Creek Equipment Co.·November 9, 2016