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

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    BCI WW1021 PC APPLICATION

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    SURE-SCOPE

    FDA UDI
    OBP CORPORATION·M648C0902050·SINGLE-USE LIGHTED LARYNGOSCOPE SIZE MILLER 00

    LEONE SPA

    FDA UDI
    LEONE SPA·08033707065647·INTRAORAL ELASTICS 2,5 oz 3/16" green

    MILLENNIUM

    FDA UDI
    Avalign Technologies, Inc.·00190776351847·Exodontia Oral Gauze

    N/A

    FDA UDI
    BIOMET MICROFIXATION, INC·00841036027773·

    POWERLINK SYSTEM

    FDA Adverse Event
    Death ·ENDOLOGIX, INC.·Product code MIH·August 27, 2009

    CASTLE PERACETIC ACID BIOLOGICAL INDICATOR KIT

    FDA 510(k)
    FDA Class 2 ·General Hospital

    EMBRYON SINGLE AND DOUBLE LUMEN NEEDLES

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    ENDOWRIST

    FDA Adverse Event
    Malfunction ·INTUITIVE SURGICAL, INC·Product code NAY·July 29, 2025

    ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD

    FDA Adverse Event
    Injury ·SYNTHES USA·Product code NKB·December 29, 2015

    HEART START MRX

    FDA Adverse Event
    Malfunction ·PHILIPS MEDICAL SYSTEMS·Product code MKJ·April 19, 2013

    CORE SABER DRILL

    FDA Adverse Event
    Malfunction ·STRYKER INSTRUMENTS KALAMAZOO·Product code ERL·April 19, 2011

    UNK DEPUY HIP LINER

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS, INC.·Product code KWB·July 30, 2008

    Pronto Series Power Wheelchair, model M51.

    FDA Recall
    Terminated ·Invacare Corporation·Product code ITI·May 2, 2005

    Aurora 4 Series, Aurora 7 lighthead; Models: AUA7 (including TV models). The Aurora Series is intended to illuminate the surgical field and ensure visibility of the surgical site.

    FDA Enforcement
    Class II ·Ongoing·DKK Dai-Ichi Shomei Co., Ltd.·August 21, 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