BEUDAMED
    17 results · 23ms · Sources: EU EUDAMED, US FDA

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    COAXIAL ACCORDION STONE MANAGEMENT DEVICE, MODEL: COAC12005 - COA20015

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

    Merit Medical®

    FDA UDI
    Merit Medical Systems, Inc.·00884450169636·

    AL-2000 COMBINED BIOMETER AND PACHYMETER

    FDA 510(k)
    FDA Class 2 ·Radiology

    THE O'NEIL STERILE FIELD URINARY CATHETER KIT

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

    INFINION CX

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·March 28, 2024

    SPECTRA WAVEWRITER

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC NEUROMODULATION CORPORATION·Product code LGW·January 10, 2025

    AMINGO

    FDA Adverse Event
    Malfunction ·DATEX-OHMEDA, INC.·Product code BSZ·December 9, 2016

    AMINGO

    FDA Adverse Event
    Malfunction ·DATEX-OHMEDA, INC.·Product code BSZ·December 30, 2016

    AMINGO

    FDA Adverse Event
    Malfunction ·DATEX-OHMEDA, INC.·Product code BSZ·December 29, 2016

    AMINGO

    FDA Adverse Event
    Malfunction ·DATEX-OHMEDA, INC.·Product code BSZ·January 4, 2017

    NUMERIS TETHERED COAGULATION SYSTEM WITH VISITRAX

    FDA Adverse Event
    Death ·ATRICURE, INC.·Product code OCL·November 13, 2018

    ULTRACISION HARMONIC ACE

    FDA Adverse Event
    Malfunction ·ETHICON ENDO-SURGERY, LLC.·Product code LFL·April 29, 2013

    MAXPLUS CLEAR NEEDLELESS CONNECTOR

    FDA Adverse Event
    Malfunction ·CAREFUSION CORP·Product code FPA·April 29, 2011

    ASCENSIA ELITE BASIC

    FDA Adverse Event
    Malfunction ·BAYER HEALTHCARE, LLC·Product code NBW·July 24, 2008

    Dr. Fog Endoscopic Fog Prevention Kit; model DF-3120. Each box contains 40 packages. Each package contains one Dr. Fog treated sponge.

    FDA Recall
    Terminated ·Aspen Surgical Products, Inc.·Product code GCJ·April 30, 2003

    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