BEUDAMED
    18 results · 20ms · Sources: EU EUDAMED, US FDA

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    ORALIEF OTC TOOTHPASTE FOR SENSITIVE TEETH

    FDA 510(k)
    FDA Class 2 ·Dental

    RAM®

    FDA UDI
    LSI Solutions, Inc.·00850200006704·RAM® RACK Suture Management System

    Regent

    FDA UDI
    SPINAL ELEMENTS·00840916114817·Regent ACP 2-Level, 28mm

    ITOTAL IDENTITY TIBIAL CUT GUIDE LARGE RIGHT

    FDA UDI
    Conformis, Inc.·00810933030551·

    SchureMed

    FDA UDI
    SCHUERCH CORPORATION·00810014605203·MAQUET/SIEMENS 1130 5.25" SOFTCARE PLUS

    Slimplicity Anterior Cervical Plate System

    FDA UDI
    PRECISION SPINE, INC.·00815362021187·2 Level 28mm Plate

    Merit Medical®

    FDA UDI
    Merit Medical Systems, Inc.·00884450180594·

    Merit Medical®

    FDA UDI
    Merit Medical Systems, Inc.·00884450180853·

    Welch Allyn, Inc.

    FDA UDI
    WELCH ALLYN, INC.·00732094036114·Temp; Skin Sensor, YSI #4499 Disposable, 100/box

    GORE-TEX DUALMESH PLUS BIOMATERIAL WITH HOLES

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

    ENTEC CONTROLLER, ENTEC PATIENT CABLE, FOOTSWITCH, POWERCORD, PLASMA WAND

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

    WAVEWRITER ALPHA

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·February 20, 2023

    CANCELLO-PURE WEDGE

    FDA Adverse Event
    Injury ·RTI BIOLOGICS·Product code MQV·March 23, 2011

    IMPAX CV OUTBOUND (RESULTS MANAGEMENT 2.08)

    FDA Adverse Event
    Malfunction ·AGFA HEALTHCARE CORP·Product code LLZ·September 17, 2013

    PROMOTE RF CRT-D

    FDA Adverse Event
    Injury ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code NIK·April 26, 2013

    SUPERDIMENSION INREACH SYSTEM

    FDA Adverse Event
    Malfunction ·SUPERDIMENSION INC.·Product code JAK·May 6, 2011

    PINNACLE MTL INS NEUT36IDX54OD

    FDA Adverse Event
    Malfunction ·DEPUY ORTHOPAEDICS, INC. 1818910 ·Product code KWA·July 18, 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