BEUDAMED
    12 results · 38ms · Sources: EU EUDAMED, US FDA

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    NIM4

    FDA 510(k)
    FDA Class 2 ·Ear, Nose, Throat

    HERA W10 Diagnostic Ultrasound System

    FDA 510(k)
    FDA Class 2 ·Radiology

    MODIFICATION TO:ACCU-CHEK POCKET COMPASS DIABETES MANAGEMENT SOFTWARE

    FDA 510(k)
    FDA Class 2 ·General Hospital

    IMP CBL DIA2 SS CABLE SLEEVE

    FDA Adverse Event
    Injury ·BIOMET FRANCE S.A.R.L.·Product code JDQ·November 18, 2016

    IMP CBL DIA2 SS CABLE SLEEVE

    FDA Adverse Event
    Injury ·BIOMET FRANCE S.A.R.L.·Product code JDQ·November 18, 2016

    IMP CBL DIA2 SS &CABLE SLEEV

    FDA Adverse Event
    Malfunction ·BIOMET FRANCE S.A.R.L.·Product code JDQ·November 30, 2016

    IMP CBL DIA2 SS & CABLE SLEEVE

    FDA Adverse Event
    Injury ·BIOMET FRANCE S.A.R.L.·Product code JDQ·July 20, 2016

    INTERSTIM II

    FDA Adverse Event
    Injury ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code EZW·February 28, 2013

    ONE TOUCH PING GLUCOSE MANAGEMENT SYSTEM

    FDA Adverse Event
    Malfunction ·ANIMAS CORP.·Product code LZG·January 12, 2011

    STOCKERT S5 SYSTEM

    FDA Adverse Event
    Other ·SORIN GROUP DEUTSCHLAND·Product code DTQ·July 22, 2014

    INFLATOR KIT 18INFKIT BALLOON

    FDA Adverse Event
    Injury ·MEDTRONIC XOMED INC.·Product code LRC·August 15, 2014

    GXL acetabular liners, orthopedic hip implant component. Product Line Numbers: a. ALL POLYETHYLENE ACETABULAR CUP, CEMENTED 22MM SZ 42, REF 106-22-42; b. ALL POLYETHYLENE ACETABULAR CUP, CEMENTED 22MM SZ 44, REF 106-22-44; c. ALL POLYETHYLENE ACETABULAR CUP, CEMENTED 22MM SZ 46, REF 106-22-46; d. ALL POLYETHYLENE ACETABULAR CUP, CEMENTED 22MM SZ 48, REF 106-22-48; e. ALL POLYETHYLENE ACETABULAR CUP, CEMENTED 22MM SZ 50, REF 106-22-50; f. ALL POLYETHYLENE ACETABULAR CUP, CEMENTED 22MM SZ 52, REF 106-22-52; g. ALL POLYETHYLENE ACETABULAR CUP, CEMENTED 22MM SZ 54, REF 106-22-54; h. ALL POLYETHYLENE ACETABULAR CUP, CEMENTED 28MM SZ 48, REF 106-28-48; i. ALL POLYETHYLENE ACETABULAR CUP, CEMENTED 28MM SZ 50, REF 106-28-50; j. ALL POLYETHYLENE ACETABULAR CUP, CEMENTED 28MM SZ 52, REF 106-28-52; k. ALL POLYETHYLENE ACETABULAR CUP, CEMENTED 28MM SZ 54, REF 106-28-54; l. ALL POLYETHYLENE ACETABULAR CUP, CEMENTED 28MM SZ 56, REF 106-28-56; m. ALL POLYETHYLENE ACETABULAR CUP, CEMENTED 28MM SZ 58, REF 106-28-58; n. ALL POLYETHYLENE ACETABULAR CUP, CEMENTED 28MM SZ 60, REF 106-28-60; o. ALL POLYETHYLENE ACETABULAR CUP, CEMENTED 32MM SZ 52, REF 106-32-52; p. ALL POLYETHYLENE ACETABULAR CUP, CEMENTED 32MM SZ 54, REF 106-32-54; q. ALL POLYETHYLENE ACETABULAR CUP, CEMENTED 32MM SZ 56, REF 106-32-56; r. ALL POLYETHYLENE ACETABULAR CUP, CEMENTED 32MM SZ 58, REF 106-32-58; s. ALL POLYETHYLENE ACETABULAR CUP, CEMENTED 32MM SZ 60, REF 106-32-60

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·September 21, 2022