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

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    SYNCHRON LX 20 CLINICAL CHEMISTRY SYSTEM, SYNCHRON LX ALBUMIN REAGENT, SYNCHRON LX CREATININE PICRIC REAGENT, SYNCHRON L

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    UNICEL DXC 800 SYNCHRON SYSTEM

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER, INC.·Product code JGS·February 21, 2012

    N/A

    FDA UDI
    Tyber Medical, LLC·M695M9652400·

    VESSELOOPS

    FDA 510(k)
    FDA Class 1 ·General, Plastic Surgery

    NATURAL-KNEE TIBIAL AND FEMORAL SPACERS

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Compress Device Short Anchor Plug, 24 MM-For Correction of revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement. Item Number: 178566

    FDA Enforcement
    Class II ·Ongoing·Biomet, Inc.·November 29, 2023

    SPRINT QUATTRO

    FDA Adverse Event
    Injury ·MPRI·Product code LWS·February 15, 2013

    PRECISION TEST STRIPS

    FDA Adverse Event
    Malfunction ·ABBOTT DIABETES CARE, INC. USA·Product code NBW·January 20, 2011

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·July 29, 2014

    BA102

    FDA Adverse Event
    Malfunction ·NAKANISHI INC.·Product code EGS·March 31, 2016

    BA105

    FDA Adverse Event
    Malfunction ·NAKANISHI INC.·Product code EGS·March 28, 2016

    NSK

    FDA Adverse Event
    Injury ·NAKANISHI INC.·Product code EGS·August 29, 2017

    Roadrunner Uniglide Hydrophilic Wire Guide, Catalog Numbers and GPN: HPWA-18-260, G30489; HPWA-18-320, G30490; HPWA-25-260, G30491; HPWA-35-260, G30492; HPWAS-35-260, G30506; HPW-35-150, G56149; HPW-35-180, G56150; HPWS-35-150, G56152; HPWS-35-180, G56153; HPWA-35-80, G56172; HPWA-35-150, G56173; HPWA-35-180, G56174; HPWA-18-180, G56160; HPWAS-35-150, G56176; HPWAS-35-180, G56177. Used with vascular catheter. Roadrunner UniGlide Hydrophilic Wire Guide is constructed from a steerable, metallic core with a polymer coating. A hydrophilic coating is applied over the radiopaque polymer jacket. Sterile- Individual product is packaged in a Tyvek-film sterilizable outer pouch and boxed in a quantity of five.

    FDA Enforcement
    Class I ·Terminated·Cook Inc.·August 31, 2016