BEUDAMED
    11 results · 20ms · Sources: EU EUDAMED, US FDA

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    FUSE CAGE

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    CoRoent

    FDA UDI
    Nuvasive, Inc.·00887517564610·CoRoent Ant TLIF PEEK, 12x11x28mm 8°

    ArgenZ Anterior 95x25 #4

    FDA UDI
    ARGEN CORPORATION, THE·D818121288·Dental porcelain/ceramic restoration kit

    ORS-1000LD

    FDA 510(k)
    FDA Class 1 ·Physical Medicine

    STAXX XD SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    HEMOCONCENTRATOR BC 20 PLUS

    FDA Adverse Event
    Malfunction ·MAQUET CARDIOPULMONARY AG·Product code KDI·April 1, 2016

    OT VERIO IQ METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·May 20, 2013

    BIOGEL PI IND SZ 7.5

    FDA Adverse Event
    Injury ·MOLNLYCKE HEALTHCARE·Product code KGO·September 22, 2014

    TRIAGE CARDIAC PANEL 25 TEST

    FDA Adverse Event
    Malfunction ·ALERE SAN DIEGO, INC.·Product code MMI·May 5, 2011

    Eversense CGM SENSOR (FG-4200-00-301)-Continuous Glucose Monitor

    FDA Enforcement
    Class II ·Terminated·Senseonics, Inc.·November 6, 2019

    Acidified Concentrate Distribution and Storage-The Isopure ACDS (Acidified Concentrate Distribution and Storage) with remote fill is intended to be used in Hemodialysis facilities for the storage and distribution of acid concentrate to be used in the treatment of Hemodialysis patients Model: ACDS MD704262

    FDA Enforcement
    Class II ·Terminated·Isopure Corp·September 21, 2022