BEUDAMED
    12 results · 28ms · Sources: EU EUDAMED, US FDA

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    ULTRACHEM E-GLU #64976 & 65040

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    VIVACIT-E DM LINER 28 X 38MM

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code LPH·August 26, 2020

    STRADIS

    FDA UDI
    STRADIS MEDICAL, LLC·M75268214701·CUSTOM SURGICAL KIT VEIN PACK

    STERLING

    FDA UDI
    BENCO DENTAL SUPPLY CO.·00366975064301·

    FULLY AUTOMATIC WIRELESS BLOOD PRESSURE WRIST MONITOR

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    SEER LIGHT COMPACT DIGITAL HOLTER RECORDER

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    R SERIES DEFIBRILLATOR

    FDA Adverse Event
    Malfunction ·ZOLL MEDICAL CORPORATION·Product code MKJ·January 15, 2014

    PRIMEADVANCED

    FDA Adverse Event
    Malfunction ·MDT PUERTO RICO OPERATIONS CO·Product code LGW·November 6, 2012

    GENTLEPOWER LUX HANDPIECE 25LPA

    FDA Adverse Event
    Injury ·KAVO DENTAL GMBH·Product code EFB·August 24, 2010

    PM1214 NUANCE SR RF; PM1230 and PM2230 NUANCE MRI; PM2214 NUANCE DR RF These low voltage (LV) devices are implantable pacemaker pulse generators, intended to be permanently implanted in the body, that have a power supply and electronic circuits that produce a periodic electrical pulse to stimulate the heart. These devices are used as a substitute for the heart's intrinsic pacing system to correct both intermittent and continuous cardiac rhythm disorders.

    FDA Enforcement
    Class II ·Terminated·St Jude Medical Inc.·October 25, 2017

    Zimmer, Cuff Tourniquet Dual Hose Single Bladder Maroon Reprocessed by Sterilmed, Sterile EO, Rx only.

    FDA Enforcement
    Class II ·Terminated·STERILMED, INC.·December 16, 2015

    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