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

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    APPOSE DISPOS. SKIN STAPLER W/AUTO

    FDA 510(k)
    FDA Class 2 ·General Hospital

    NAR

    FDA UDI
    NORTH AMERICAN RESCUE, LLC·10842209133663·

    PULSEOX 5500 FINGER DEVICE, PULSEOX 7500 WRISTWATCH DEVICE

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    ELLIPSE MAGEC SPINAL BRACING AND DISTRACTION SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    MAGEC SPINAL BRACING AND DISTRACTION SYSTEM

    FDA Adverse Event
    Injury ·ELLIPSE TECHNOLOGIES, INC.·Product code PGN·June 23, 2014

    MAGEC SPINAL BRACING AND DISTRACTION SYSTEM

    FDA Adverse Event
    Injury ·ELLIPSE TECHNOLOGIES, INC.·Product code PGN·May 25, 2014

    MAGEC SPINAL BRACING AND DISTRACTION SYSTEM

    FDA Adverse Event
    Injury ·ELLIPSE TECHNOLOGIES, INC.·Product code PGN·May 21, 2014

    INZII RETRIEVAL

    FDA Adverse Event
    Malfunction ·APPLIED MEDICAL·Product code GCJ·May 23, 2014

    RUSCH 100% SILICONE 2 WAY PED 3CC 8FR 10/BX

    FDA Adverse Event
    Malfunction ·TELEFLEX MEDICAL·Product code BSR·November 14, 2012

    LIFEPAK 20

    FDA Adverse Event
    Malfunction ·PHYSIO-CONTROL·Product code MKJ·September 14, 2010

    PKG, SCHERTEL FORCEPS, FENESTRATED, P/N 0250080312. Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and surgical auxiliaries such as suturing material. Some instruments have radio frequency (RF) ports which allow them to be used for electrosurgery. Laparoscopic surgical manual instruments are designed to be used endoscopically through cannulae to perform cutting, grasping, dissecting, retracting, and manipulating functions. This device does not sustain or support life.

    FDA Enforcement
    Class II ·Terminated·Stryker Endoscopy·December 24, 2014

    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