BEUDAMED
    11 results · 19ms · Sources: EU EUDAMED, US FDA

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    CAPILLARYS IMMUNOTYPING, MODEL 2100

    FDA 510(k)
    FDA Class 2 ·Immunology

    Merit Medical®

    FDA UDI
    Merit Medical Systems, Inc.·00884450180136·

    SOMNO STAR & SERIES SLEEP SYSTEM

    FDA 510(k)
    FDA Class 2 ·Neurology

    ULTRASOUND SCANNER, TYPE 1101

    FDA 510(k)
    FDA Class 2 ·Radiology

    EXOSEAL VASCULAR CLOSURE DEVICE (VCD)

    FDA Adverse Event
    Death ·CORDIS DE MEXICO·Product code MGB·April 29, 2013

    SD/PD LONG CURVED

    FDA Adverse Event
    Malfunction ·STRYKER INSTRUMENTS KALAMAZOO·Product code HBE·April 26, 2011

    PERMACLIP REUSABLE HANDLE W/DISP. CLIP

    FDA Adverse Event
    Malfunction ·DESIGN STANDARDS CORP·Product code GDO·July 25, 2008

    ARROW CATH-LAB SHEATH INTRO SET

    FDA Adverse Event
    Malfunction ·ARROW INTERNATIONAL INC.·Product code DQY·October 9, 2019

    Roche MODULAR ANALYTICS EVO Serum Work Area (SWA), Operator's Manual Software Version 08-02; Filter label: Filter (N) Mat. No 03149773001, Contents 1, 768-320 Filter (N). Product Usage: Fully automated immunoassay analyzer intended for the in-vitro quantitative/qualitative determination of analytes in body fluids.

    FDA Enforcement
    Class II ·Terminated·Roche Diagnostics Operations, Inc.·June 25, 2014

    Philips Allura Xper Interventional Fluoroscopic X-ray Systems, specifically the Disk Bay of the PC component of affected systems. Affected PCs: FlexVision PC Allura Xper Model Name - Model Number: Allura Xper FD10 722003 722010 722026; Allura Xper FD10/10 722005 722011 722027; Allura Xper FD20 722006 722012 722028; Allura Xper FD20 Biplane 722008 722013; Allura Xper FD20 Biplane OR Table 722025; Allura Xper FD20 OR Table 722023 722035; Allura Xper FD20/10 722029; Allura Xper FD20/15 722058; Allura Xper FD20/15 OR Table 722059; Allura Xper FD20/20 722038; Allura Xper FD20/20 OR Table 722039;

    FDA Enforcement
    Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·February 28, 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