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

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    MANDREL GUIDEWIRES OR M-WIRE

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    Cook

    FDA UDI
    COOK INCORPORATED·00827002143296·Percutaneous Pigtail Nephrostomy Set

    iDuo/ iTotal/ Identity/ Imprint

    FDA UDI
    Conformis, Inc.·00810933031671·Patellar Osteotomy Guide

    PASCO MIC AND MIC/ID PANELS

    FDA 510(k)
    FDA Class 2 ·Microbiology

    THERMOFLEX SYSTEM

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    AVISTA? MRI

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC NEUROMODULATION CORPORATION·Product code LGW·November 5, 2025

    E-POLY TIBIAL BEARINGS

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

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·April 26, 2013

    LIGHTSPEED VCT

    FDA Adverse Event
    Injury ·GE MEDICAL SYSTEMS LLC·Product code JAK·April 22, 2011

    LIGACLIP ENDOSCOPIC ROTATING MULTIPLE CLIP APPLIER 20 MEDIUM-LARGE TITANIUM

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

    ECHOTIP PROCORE HIGH DEFINITION ULTRASOUND BIOPSY NEEDLE

    FDA Adverse Event
    Malfunction ·COOK IRELAND LTD·Product code FCG·February 22, 2024

    InnerCool RTx Endovascular System, Model Numbers: 861470 (120V), 861472 (240V). Product Usage: The InnerCool RTx device is a thermal regulating system intended to induce, maintain and reverse mild hypothermia, to achieve and/or maintain normothermia, and for use in fever reduction. K080908

    FDA Enforcement
    Class II ·Terminated·Philips Healthcare·February 5, 2014

    InnerCool RTx Endovascular System, Model Numbers: 861470 (120V), 861472 (240V). Product Usage: The InnerCool RTx device is a thermal regulating system intended to induce, maintain and reverse mild hypothermia, to achieve and/or maintain normothermia, and for use in fever reduction. K080908

    FDA Recall
    Terminated ·Philips Healthcare·Product code NCX·January 13, 2014

    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