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

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    MYOHEALTH CLENCHING INHIBITOR

    FDA 510(k)
    FDA Unclassified ·Unknown

    BiomarC®

    FDA UDI
    Carbon Medical Technologies, Inc.·00858015005295·Preloaded Carbon Tissue Marker with Enhanced MR...

    Leksell Stereotactic System

    FDA UDI
    Elekta Solutions AB·07340201502266·Post Insulated anterior

    Myo/Wire II

    FDA UDI
    A & E MEDICAL CORPORATION·10841291101239·SS Suture, 5 per sleeve

    InTess Lumbar Cage

    FDA UDI
    Kalitec Direct LLC·B07312K0103150·Shaver, Closed, 15mm

    neoWave LS

    FDA UDI
    XENIX MEDICAL LLC·00818345024106·Paddle Shaver, 15mm

    VENTRICULAR ANALYSIS TOOLKIT OPTION

    FDA 510(k)
    FDA Class 2 ·Radiology

    ISCREEN VISION SCREENER

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    Optetrak Logic

    FDA UDI
    Exactech, Inc.·10885862158338·

    LOGIC KNEE COMPONENTS

    FDA Adverse Event
    Injury ·EXACTECH, INC.·Product code JWH·November 24, 2025

    MINILOC SAFETY INFUSION SET

    FDA Adverse Event
    Injury ·BARD ACCESS SYSTEMS·Product code FPA·May 8, 2008

    ENDURON NEUT 56 OR 68ODX28ID

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS, INC.·Product code LPH·June 23, 2008

    STARCLOSE SE VASCULAR CLOSURE SYSTEM

    FDA Adverse Event
    Injury ·AV-TEMECULA-CT·Product code MGB·April 5, 2011

    LOGIC

    FDA Adverse Event
    Injury ·EXACTECH, INC.·Product code JWH·July 17, 2023

    Stryker Locking Screw, Fully Threaded T2 Tibia ¿5x35 mm Catalog Number: 18965035S - Product Usage: Stryker implants are single use devices intended for the temporary fixation, correction or stabilization of bones.

    FDA Enforcement
    Class II ·Terminated·Stryker GmbH·June 24, 2020

    LOGIC

    FDA Adverse Event
    Injury ·EXACTECH, INC.·Product code JWH·May 1, 2023

    IOL Master 5.5: Software versions 7.5 and 7.7; Ophthalmic: used to obtain ocular measurements and perform calculations to allow physicians to determine appropriate IOL power and type for implantation.

    FDA Enforcement
    Class II ·Terminated·Carl Zeiss Meditec AG·December 9, 2015

    LOGIC KNEE COMPONENTS

    FDA Adverse Event
    Injury ·EXACTECH, INC.·Product code JWH·June 24, 2025

    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