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

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    AMICAS PACS, VERSION 6.0

    FDA 510(k)
    FDA Class 2 ·Radiology

    Welch Allyn, Inc.

    FDA UDI
    WELCH ALLYN, INC.·00732094113280·2-Piece Cuff and Bladder, Newborn with 2-Tube ...

    CYTOFLEX

    FDA 510(k)
    FDA Class 2 ·Dental

    MEDLINK DIAGNOSTIC OFFLINE WORKSTATION

    FDA 510(k)
    FDA Class 2 ·Radiology

    STOCKERT ELECTRICAL VENOUS OCCLUDER (EVO)

    FDA Adverse Event
    Other ·SORIN GROUP, DEUTSCHLAND·Product code DXC·April 15, 2010

    ISODUR PROSTHESIS HEAD 12/14 32MM XL

    FDA Adverse Event
    Malfunction ·AESCULAP AG AND CO KG·Product code LPH·March 28, 2014

    INFUSE BONE GRAFT/LT-CAGE

    FDA Adverse Event
    Injury ·MEDTRONIC·Product code NEK·November 12, 2013

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    FDA Adverse Event
    Injury ·ANIMAS CORPORATION·Product code LZG·April 29, 2013

    LIFEVEST WCD 4000 SYSTEM

    FDA Adverse Event
    Malfunction ·ZOLL LIFECOR CORPORATION·Product code MVK·April 28, 2011

    NEXGEN COMPLETE KNEE SOLUTION LEGACY KNEE-POSTERIOR STABLIZED LPS-FLEX ARTICULAR

    FDA Adverse Event
    Malfunction ·ZIMMER, INC.·Product code JWH·July 25, 2008

    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