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

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    HD ENDOEYE LAPARO-THORACO VIDEOSCOPE OLYMPUS LTF TYPE VH

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

    OLYMPUS ENDOSCOPIC FLUSHING PUMP MODEL OFP-1

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

    DYNATRON STS RX

    FDA 510(k)
    FDA Class 2 ·Neurology

    Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes: K08-PI (Custom Fluid Management Kit), REF: K08-02042 K08-02948 K08-03026 K08-03119 An intravascular administration set is a device used to administer fluids from a container to a patient's vascular system through a needle or catheter inserted into a vein.

    FDA Enforcement
    Class II ·Ongoing·Merit Medical Systems, Inc.·August 21, 2024

    SECURE II MED/SURG BED

    FDA Adverse Event
    Malfunction ·STRYKER MEDICAL-KALAMAZOO·Product code FNL·April 26, 2013

    9800

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·April 14, 2011

    TAXUS EXPRESS2 PACLITAXEL - ELUTING CORONARY STENT SYSTEM

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC·Product code NIQ·July 23, 2008

    FAST-FIX 360 CURVED NDL DELIVERY SYS

    FDA Adverse Event
    Injury ·SMITH & NEPHEW, INC.·Product code GAT·February 8, 2022

    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

    FAST-FIX 360 CURVED NDL DELIVERY SYS

    FDA Adverse Event
    Injury ·SMITH & NEPHEW, INC.·Product code GAT·February 8, 2022

    FAST-FIX 360 CURVED NDL DELIVERY SYS

    FDA Adverse Event
    Injury ·SMITH & NEPHEW, INC.·Product code GAT·February 8, 2022

    Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes: K08-PI (Custom Fluid Management Kit), REF: K08-02042 K08-02948 K08-03026 K08-03119 An intravascular administration set is a device used to administer fluids from a container to a patient's vascular system through a needle or catheter inserted into a vein.

    FDA Recall
    Open, Classified ·Merit Medical Systems, Inc.·Product code OJA·June 11, 2024

    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