BEUDAMED
    17 results · 28ms · Sources: EU EUDAMED, US FDA

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    MODIFICATION TO ZILVER 635 BILIARY STENT

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

    ZILVER FLEX 35 BILIARY SELF-EXPANDING STENT

    FDA Adverse Event
    Malfunction ·COOK INC·Product code FGE·February 24, 2017

    ZILVER FLEX 35 BILIARY SELF-EXPANDING STENT

    FDA Adverse Event
    Malfunction ·COOK INC·Product code NIO·July 25, 2017

    SchureMed

    FDA UDI
    SCHUERCH CORPORATION·00810014604244·STERIS C-MAX 2" STANDARD

    Merit Medical®

    FDA UDI
    Merit Medical Systems, Inc.·00884450283615·

    Disposable Cuff

    FDA UDI
    SUNTECH MEDICAL, INC.·10840935100515·

    MONOFILAMENT BIOSYN SUTURE

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    DAUM DOUBLE-SHOOT BISOPSY GUN

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

    CELOX GAUZE

    FDA Adverse Event
    Injury ·MEDTRADE PRODUCTS LIMITED·Product code FRO·February 14, 2023

    CELOX GAUZE

    FDA Adverse Event
    Injury ·MEDTRADE PRODUCTS LIMITED·Product code FRO·October 12, 2022

    YELLOWFINS

    FDA Adverse Event
    Malfunction ·ALLEN MEDICAL SYSTEMS·Product code EYD·March 29, 2013

    M SERIES

    FDA Adverse Event
    Malfunction ·ZOLL MEDICAL CORPORATION·Product code MKJ·April 5, 2011

    REALIZE ENDOSCOPIC DISSECTOR

    FDA Adverse Event
    Malfunction ·OBTECH MEDICAL SARL·Product code LTI·July 17, 2008

    CELOX GAUZE

    FDA Adverse Event
    Injury ·MEDTRADE PRODUCTS LIMITED·Product code QSY·June 10, 2025

    2.5 mm Reaming Rod W/Ball Tip 650 mm, Sterile

    FDA Enforcement
    Class II ·Terminated·Synthes (USA) Products LLC·November 30, 2016

    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

    Stryker MA204 Bed Model (FL25E) Beds are intended for medical purposes in both general patient care as well as critical care environments. Each uses built-in electric motors and controls which can be operated by the patient, or caregiver, to adjust the height and/or surface contour of the bed.The devices listed above also include movable and latchable side rails which can be lowered or raised to help prevent patient fall and subsequent injury. The Beds include an optional Scale (Models: FL20E, FL25E, FL28C, FL28EX) as well as an optional Bed Exit (1 Zone) or Chaperone

    FDA Enforcement
    Class II ·Terminated·Stryker Medical Division of Stryker Corporation·July 4, 2012