BEUDAMED
    13 results · 26ms · Sources: EU EUDAMED, US FDA

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    TWINGUARD WITH CAPNOGRAPH ACCESSORY

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    iTotal® CR Tibial Keel Punch Tip

    FDA UDI
    Conformis, Inc.·00850268007255·iTotal® CR 14mm Tibial Keel Punch Tip Reusable ...

    ACCUCLOT DRVVT SCREEN, CATALOG NO. A6094

    FDA 510(k)
    FDA Class 1 ·Hematology

    SYNTHES (USA) IMF SCREWS

    FDA 510(k)
    FDA Class 2 ·Dental

    E-POLY TIBIAL BEARINGS

    FDA Adverse Event
    Injury ·BIOMET UK LTD.·Product code JWH·July 12, 2017

    ACCENT DR RF

    FDA Adverse Event
    Death ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code DXY·April 26, 2013

    6F ANGIO-SEAL EVOLUTION

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL·Product code MGB·April 22, 2011

    ENDOPATH DEXTRUS SEAL CAP ASSEMBLY WITH ACCESSORIES

    FDA Adverse Event
    Malfunction ·ETHICON ENDO-SURGERY, LLC·Product code GCJ·July 24, 2008

    KYPHON KURVE BONE FILLER DEVICE 13GA

    FDA Adverse Event
    Malfunction ·MEDTRONIC MEXICO·Product code KIH·July 14, 2020

    HANDLE CEV102910R DIA 10MM ANG W/RATCHET [MXI/XOM]

    FDA Adverse Event
    Injury ·XOMED MICROFRANCE MFG·Product code GCJ·December 20, 2013

    On-Board Imager - Exact Arm Elbow Motor Shaft (kVD, kVS, and MV) with ''Type 01" elbow motors. Product Usage: The On-Board Imager device is an x-ray device used for evaluation of correct patient position in relation to isocenter and verification of treatment fields in relation to anatomical and fiducial landmarks.

    FDA Enforcement
    Class II ·Terminated·Varian Medical Systems, Inc.·April 30, 2014

    Alaris Syringe Pump, Model No. 8110. Delivers fluids. Expansion of Affected Units: BOM Housing Assembly Service, Part No. 49000226, and Lower Housing/Carriage Block Assembly, Part No. 148188-100.

    FDA Enforcement
    Class I ·Terminated·CareFusion 303, Inc.·August 26, 2015

    CADD-Solis VIP ambulatory Infusion Pumps, Model 2110. Indicated for the following uses: Intra-arterial, subcutaneous, intraperitoneal, in close proximity to nerves, into an intraoperative site, epidural space or subarachnoid space. Therapies that require a continuous rate of infusion, intermittent bolus, and/or with patient-controlled demand doses.

    FDA Enforcement
    Class I ·Ongoing·Smiths Medical ASD Inc.·August 14, 2024