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

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    LACRICATH LACRIMAL DUCT CATHETER

    FDA 510(k)
    FDA Unclassified ·Unknown

    BIO-MODULAR SHOULDER SYSTEM

    FDA UDI
    Biomet Orthopedics, LLC·00880304433496·

    7450 RV2 MASK

    FDA UDI
    HANS RUDOLPH, INC.·00817136025414·7450 MEDIUM W/HG MGC MADAPT

    PRECISION MONTAGE MRI

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·November 26, 2020

    XIVE DENTAL IMPLANT SYSTEM

    FDA 510(k)
    FDA Class 2 ·Dental

    STERI-DENT, STERI-SURE

    FDA 510(k)
    FDA Class 2 ·General Hospital

    BD ULTRA FINE¿ PEN NEEDLES

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON AND CO.·Product code FMI·December 9, 2019

    BIOMEDICS 1 DAY (52%) STRIP (OCUFILCON B)

    FDA Adverse Event
    Injury ·COOPERVISION CARRIBEAN CORPORATION·Product code MVN·August 29, 2019

    RUSCH GREENSPEC FO BLADE, MILLER 2

    FDA Adverse Event
    Malfunction ·TELEFLEX MEDICAL·Product code CAL·May 7, 2013

    VASOVIEW HEMOPRO 2 EVH SYSTEM

    FDA Adverse Event
    Malfunction ·MAQUET CARDIOVASCULAR, LLC·Product code GEI·May 17, 2011

    NITE GUARD

    FDA Adverse Event
    Malfunction ·RANIR, LLC·Product code OBR·May 1, 2014

    BD ULTRA-FINE NANO PEN NEEDLES 4MM (5/32) 32G

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON AND CO.·Product code FMI·October 15, 2020

    BD ULTRA FINE¿ PEN NEEDLES

    FDA Adverse Event
    Malfunction ·BECTON, DICKINSON AND CO.·Product code FMI·December 27, 2019

    BIOMOD PORCOAT HA GLENTRAY; Custom Shoulder Products Item Nos. PM0000097 PM555140 PM555147 PM555319 PM555418 113867 113865 113863 Product Usage: Total Shoulder Replacement

    FDA Recall
    Terminated ·Zimmer Biomet, Inc.·Product code MBF·August 21, 2019

    BIOMOD PORCOAT HA GLENTRAY; Custom Shoulder Products Item Nos. PM0000097 PM555140 PM555147 PM555319 PM555418 113867 113865 113863 Product Usage: Total Shoulder Replacement

    FDA Enforcement
    Class II ·Terminated·Zimmer Biomet, Inc.·December 4, 2019

    EMBLEM S-ICD Model A209

    FDA Enforcement
    Class I ·Terminated·Boston Scientific Corporation·February 17, 2021

    Exactech Equinoxe REVERSE SHOULDER,36mm Humeral Liner: a) +0mm, Item Number 320-36-00, b) +2.5mm, Item Number 320-36-03; Shoulder Arthroplasty

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·April 10, 2024

    Model Number L231, PROPONENT DR EL MRI Pacemaker

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·October 22, 2025