BEUDAMED
    16 results · 27ms · Sources: EU EUDAMED, US FDA

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    S38 (POLYMACON) SPHERICAL, ASPHERICAL, TORIC AND MULTIFOCAL SOFT CONTACT LENS FOR DAILY WEAR(CLEAR AND TINTED, FULLY-

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    artVeneer life

    FDA UDI
    Merz Dental GmbH·D7092002099·artVeneer life lower posteriors, XS, C1

    INFINITI® PLUS ANALYZER

    FDA UDI
    AUTOGENOMICS, INC·00850009370006·Instrumentation For Clinical Multiplex Test Sys...

    Kyocera Medical Technologies, Inc.

    FDA UDI
    KYOCERA MEDICAL TECHNOLOGIES, INC.·00841523160587·Anti-Rotation Tool

    ARTHREX DX REINFORCED MATRIX

    FDA Adverse Event
    Injury ·DSM BIOMEDICAL, INC.·Product code FTM·October 25, 2019

    CAMLOG SCREW IMPLANT SYSTEM

    FDA 510(k)
    FDA Class 2 ·Dental

    DERMAPIK II SKIN TEST SYSTEM, DERMAPIK II (SINGLE TEST DEVICE), POLYPIK II (MULTIPLE SKIN TEST DEVICE), DERMAPIK TRAY, D

    FDA 510(k)
    FDA Class 2 ·General Hospital

    Clarius Ultrasound Scanner

    FDA UDI
    Clarius Mobile Health Corp·07540205001097·

    Clarius Ultrasound Scanner

    FDA UDI
    Clarius Mobile Health Corp·07540205001196·Portable Ultrasound Scanner

    HEARTSINE SAMARITAN 300P AND PAD PAK

    FDA Adverse Event
    Malfunction ·HEARTSINE TECHNOLOGIES, LTD·Product code MKJ·February 11, 2013

    TOTALCARE SPO2RT

    FDA Adverse Event
    Malfunction ·HILL-ROM, INC.·Product code FNL·February 4, 2011

    ACCU-CHEK COMFORT CURVE TEST STRIPS

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code LFR·February 20, 2008

    T:slim Insulin Delivery System Insulin Infusion Pump

    FDA Enforcement
    Class I ·Terminated·Tandem Diabetes Care Inc·February 19, 2014

    Smiths Medical, Medfusion¿ Syringe Infusion Pump, Model 4000, Software Version V1.0 & V1.1, Reorder Numbers 4000-0100-50, 4000-0100-95, 4000-0101-50, 4000-0101-51, and 4000-0101-78. Designed for use in care areas for the administration of fluids requiring precisely controlled infusion rates.

    FDA Enforcement
    Class I ·Terminated·Smiths Medical ASD, Inc.·August 8, 2012

    Medfusion Syringe Pump Model: Model 4000-0100-50, Model 4000-0101-249, Model 4000-0101-50, Model 4000-0101-51, Model 4000-0101-78, Model 4000-0105-249, Model 4000-0105-51, Model 4000-0105-78, Model 4000-0106-00, Model 4000-0106-01, Model 4000-0106-231

    FDA Enforcement
    Class I ·Ongoing·Smiths Medical ASD Inc.·June 29, 2022

    Promote Quadra, Sterile EO, Model # / Part #: CD3221-36/100025054, 60019195; CD3223-36P/100013763; CD3239-40/100029115, 100029254, 100037181; CD3239-40Q/100029116, 100029244, 100037115

    FDA Enforcement
    Class II ·Terminated·St Jude Medical Inc.·July 4, 2018