BEUDAMED
    16 results · 21ms · Sources: EU EUDAMED, US FDA

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    STRAUMANN ORTHOSYSTEM

    FDA 510(k)
    FDA Class 2 ·Dental

    ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

    FDA UDI
    FX SOLUTIONS·03701037313404·GLENOID RESURFACING REAMER Ø36mm WITHOUT DRILL ...

    Medallion®

    FDA UDI
    Merit Medical Systems, Inc.·00884450046456·

    MATIRA ANTERIOR CERVICAL SYSTEM

    FDA UDI
    Kalitec Direct LLC·B07307K0600020·Tray Insert, Level 2

    Persona® PPS®

    FDA UDI
    Zimmer, Inc.·00889024631540·

    Persona® PPS®

    FDA UDI
    Zimmer, Inc.·00889024631533·

    STYROFOAM CUTTERS FOR BLOCK CASTING SYSTEM

    FDA 510(k)
    FDA Class 2 ·Radiology

    CORDIS TRAPEASE PERMANENT VENA CAVA FILTER AND INTRODUCTION KIT

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    PROSPACE PEEK IMPLANT 5 7X8X22MM

    FDA Adverse Event
    Malfunction ·AESCULAP AG AND CO. KG·Product code MAX·June 21, 2013

    TSPACE PEEK IMPLANT 26X11X7MM

    FDA Adverse Event
    Malfunction ·AESCULAP IMPLANT SYSTEMS·Product code MAX·October 30, 2015

    SJM TRIFECTA STENTED TISSUE VALVE

    FDA Adverse Event
    Death ·ST. JUDE MEDICAL COSTA RICA LTDA. (CS)·Product code LWR·April 5, 2013

    VITALITY

    FDA Adverse Event
    Malfunction ·GUIDANT CRM CLONMEL IRELAND·Product code LWS·April 15, 2011

    ACCU-CHEK AVIVA TEST STRIPS

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS CORP.·Product code LFR·June 12, 2008

    Belmont Rapid Infuser, a Fluid Management System, Model FMS2000.

    FDA Enforcement
    Class II ·Terminated·Belmont Instrument Corporation·October 24, 2012

    Exactech Equinoxe GLENOID,KEELED, CEMENTED,47, 50, 53 head, beta curvature, Sizes: a) Small, Item Number 314-02-12, b) Medium, Item Number 314-02-13, c) Large, Item Number 314-02-14, d) Extra Large, Item Number 314-02-15, Shoulder Arthroplasty

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

    Fortify Assura, Sterile EO, Model #/ Part #: CD1257-40/100042322, 100059623; CD1257-40Q/100042341, 100059535; CD1259-40/100041914, 100042338, 100059536, 100059646, 100081567; CD1259-40Q/100041931, 100042339, 100059537, 100059620, 100059626, 100078685; CD1263-40/100042948; CD1263-40Q/100042949; CD1357-40C/100080365, 100080377, 100083441; CD1357-40Q/100080389, 100080390, 100083388; CD1359-40/100078740, 100083267, 100096839; CD1359-40C/100078500, 100078969, 100079372, 100079373, 100083442, 100083443, 100117545; CD1359-40Q/100078804, 100079155, 100079413, 100083445, 100096884; CD1359-40QC/100078603, 100079145, 100079146, 100079239, 100083405, 100083444, 100117632, 100127000, 100127065; CD1363-40C/100080349; CD1363-40Q/100080317; CD1391-40C/100080756; CD1391-40QC/100080783; CD2257-40/100042337, 100059839; CD2257-40Q/100042342, 100059842; CD2259-40/100041893, 100042308, 100059794, 100059907, 100082567; CD2259-40Q/100041894, 100042309, 100059845, 100059873, 100078610; CD2263-40/100042950; CD2263-40Q/100043201; CD2357-40C/100080404, 100080413, 100083490; CD2357-40Q/100080319, 100080412, 100083492; CD2359-40/100078750, 100083466; CD2359-40C/100078651, 100079201, 100079240, 100079442, 100083501, 100083502, 100117546; CD2359-40Q/100078841, 100079109, 100083472; CD2359-40QC/100078652, 100079156, 100079157, 100079337, 100083407, 100083465, 100117580, 100127092, 100127103; CD2363-40C/100080416; CD2363-40Q/100080407; CD2391-40C/100080784; CD2391-40QC/100080744

    FDA Enforcement
    Class II ·Terminated·St Jude Medical Inc.·July 4, 2018