BEUDAMED
    12 results · 27ms · Sources: EU EUDAMED, US FDA

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    SP 120 SOPHISTICATE

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    DASH KNEE

    FDA 510(k)
    FDA Class 2 ·Neurology

    SYNCHRON SYSTEMS MICROALBUMIN (MA) REAGENT, MODEL 475100

    FDA 510(k)
    FDA Class 2 ·Immunology

    OPTIFLUX 180NRE DIALYZER FINISHED ASSY

    FDA Adverse Event
    Malfunction ·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code FJI·March 24, 2014

    MECHANICAL (MANUAL) WHEELCHAIR

    FDA Adverse Event
    Malfunction ·INVACARE TAYLOR STREET·Product code IOR·October 23, 2012

    FREESTYLE FLASH

    FDA Adverse Event
    Malfunction ·ABBOTT DIABETES CARE INC, USA·Product code LFR·September 6, 2007

    GLOBAL UNITE STD STEM SZ 12 Product Code: 110012100

    FDA Enforcement
    Class II ·Terminated·DePuy Orthopaedics, Inc.·January 19, 2022

    Natural-Knee System Patella Bushings Orthopedic surgical instrument. Part Number: 6290-00-703. Per the Natural-Knee II Primary System Surgical Technique, the patellar bushing is placed on the cut surface of the patella and used as a guide for the matching size patella cutter.

    FDA Enforcement
    Class II ·Terminated·Zimmer, Inc.·September 10, 2014

    Mega Needle Driver, 8MM assembly of the da Vinci S IS1200 and da Vinci Si, IS2000. Manufactured by Intuitive Surgical, Sunnyvale, CA. EndoWrist Instruments, including scissors, scalpels, forceps, needle drivers and electrocautery are intended for endoscopic manipulation of tissue, including: grasping, cutting, blunt and sharp dissection, approximation, ligation, electrocautery and suturing. Mega Needle Driver and Large Needle Driver instruments are part of the EndoWrist instrument family and are intended for use in endoscopic manipulation and suturing.

    FDA Enforcement
    Class II ·Terminated·Intuitive Surgical, Inc.·December 25, 2013

    Product Label - ACUSON Sequoia *** Power Input: 100-240V~, 13.0-5.4A, 50-60Hz *** (240)11148775 Model User Manual states - ACUSON Sequoia Diagnostic Ultrasound Systems

    FDA Enforcement
    Class II ·Ongoing·Siemens Medical Solutions USA, Inc.·April 7, 2021

    smiths medical Pneupac paraPAC plus 300 ventilator kit without PEEP and CPAP, REF P300NUS

    FDA Enforcement
    Class I ·Ongoing·Smiths Medical ASD Inc.·March 27, 2024

    paraPAC 300 ventilator kit without internal PEEP and CPAP, Item Number P300N

    FDA Enforcement
    Class I ·Ongoing·Smiths Medical ASD Inc.·October 2, 2024