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

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    VIRGINIA WATER SYSTEMS' WATER PURIFICATION SYSTEM FOR HEMODIALYSIS

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

    Arthrex®

    FDA UDI
    ARTHREX, INC.·00888867400795·1.9mm Snap-off FT Pin 16mm

    Stryker CMF MEDPOR Priority Customized Implant Kit

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

    INNOVANCE D-DIMER, MODEL OPBP09

    FDA 510(k)
    FDA Class 2 ·Hematology

    NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM

    FDA Adverse Event
    Injury ·COCHLEAR LTD·Product code MCM·March 6, 2013

    MAXIMO II CRT-D

    FDA Adverse Event
    Injury ·MEDTRONIC MED REL, INC.·Product code NIK·February 15, 2011

    OT VERIO IQ METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·August 8, 2014

    IGFBP-3 ELISA Reagent Kit; Part Number" DSL-10-6600; Lot Numbers: 992743, 992287, 991916, 991530, 991432, 990220 & 890830 This assay is intended for in vitro diagnostic use.

    FDA Recall
    Terminated ·Beckman Coulter Inc.·Product code CFL·March 30, 2011

    Presource Procedure Packs containing AAMI Level 3 surgical gowns, Multiple Catalog Numbers Produced Between September 1, 2018 and January 15, 2020. Additional kits produced through February 19, 2020 were included.

    FDA Enforcement
    Class II ·Terminated·Cardinal Health 200, LLC·February 26, 2020