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

    Get notified when this changes

    We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.
    Filters Regulation: Us FDA ×

    TEMPA-KUFF SOFT BLOOD PRESSURE CUFF, MODEL 39XXX ; VINYL,MODEL 99XXX

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    SchureMed

    FDA UDI
    SCHUERCH CORPORATION·00810014604930·BERCHTOLD B810, B710 2.25" DELUXE GEL

    Merit Medical®

    FDA UDI
    Merit Medical Systems, Inc.·00884450179857·

    Merit Medical®

    FDA UDI
    Merit Medical Systems, Inc.·00884450047569·

    PQ1

    FDA 510(k)
    FDA Class 2 ·Dental

    VORTEX ACCESS SYSTEM

    FDA 510(k)
    FDA Class 2 ·General Hospital

    TERUMO CARDIOVASCULAR PROCEDURE KIT

    FDA Adverse Event
    Malfunction ·TERUMO CARDIOVASCULAR COSTA RICA LLC·Product code OEZ·February 13, 2025

    FORTIFY DR

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

    CENTRA BED

    FDA Adverse Event
    Malfunction ·HILL-ROM, INC.·Product code FNL·April 6, 2011

    SYNCHROMED II

    FDA Adverse Event
    Injury ·MEDTRONIC NEUROMODULATION·Product code LKK·July 22, 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

    OEC 9800; OEC FluoroTrak 9800 Plus; OEC 9800 Plus; OEC 9800 MD Motorized C-arm System, 892.1650 Image-intensified fluoroscopic x-ray system. The OEC 9800 is designed to provide fluoroscopic and spot-film imaging of the patient during diagnostic, surgical and interventional procedures. The system includes features specifically designed for use in diagnostic and interventional cardiac imaging procedures and is also intended for cholangiography, endoscopic, urologic orthopedic, neurologic, vascular, critical care and emergency room procedures. It may be used for other imaging applications at the physician's discretion.

    FDA Enforcement
    Class I ·Terminated·GE OEC Medical Systems, Inc·August 1, 2012