BEUDAMED
    15 results · 25ms · Sources: EU EUDAMED, US FDA

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    CALCIUM (CPC) REAGENT SET

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    APEX Knee System

    FDA UDI
    Omni Life Science, Inc.·00841690190868·A/P Cutting Block Assy, Open Style Size 4

    Kinetic Dynamic Anterior Cervical Plate System

    FDA UDI
    Life Spine, Inc.·00190837004880·

    Image1 SPIES System

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    ACUTE CARE FACE MASK, MODEL RT040

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    Kit, Test,Alpha-Fetoprotein For Testicular Cancer

    FDA Pre-Market Approval
    FDA Class 2 ·ENZYMUN-TEST{R} AFP

    Kit, Test,Alpha-Fetoprotein For Testicular Cancer

    FDA Pre-Market Approval
    FDA Class 2 ·ENZYMUN-TEST{R} AFP

    Kit, Test,Alpha-Fetoprotein For Testicular Cancer

    FDA Pre-Market Approval
    FDA Class 2 ·ENZYMUN-TEST{R} AFP

    CAPSUREFIX NOVUS

    FDA Adverse Event
    Injury ·MPRI·Product code DTB·June 10, 2014

    HARMONIC ACE 36CM W ERG HANDLE

    FDA Adverse Event
    Malfunction ·ETHICON ENDO-SURGERY, LLC.·Product code LFL·October 7, 2010

    HEMOSPLIT, 14.5 FR, STANDARD KIT, 19 CM, STRAIGHT

    FDA Adverse Event
    Malfunction ·C. R. BARD INC. (BASD)·Product code MSD·December 4, 2012

    NON-VENTED HOSPITAL FULL FACE MASK

    FDA Adverse Event
    Malfunction ·FISHER & PAYKEL HEALTHCARE LTD·Product code MNT·April 26, 2017

    IQon Spectral CT - Model no. 728332, Computed Tomography X-Ray system Product Usage: Computed Tomography X-ray systems intended to produce cross-sectional Images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes. These devices may include signal analysts and display equipment, patient and equipment supports, components, and accessories.

    FDA Enforcement
    Class II ·Terminated·Philips Medical Systems (Cleveland) Inc·April 25, 2018

    31" (78 cm) Appx 3.4 ml, Admin Set w/20 Drop Integrated ChemoLock Drip Chamber, Spiros, Bag Hanger, REF: 011-CL3011; 40" (102 cm) Appx 4.9 ml, Admin Set w/ChemoLock, 20 Drop In-Line Drip Chamber, Spiros, Bag Hanger, REF: 011-CL3020; ChemoLock Port w/Spiros, Red Cap, REF: CL-35; 31" (79 cm) Appx 3.4 ml, Admin Set w/20 Drop Integrated ChemoLock Drip Chamber, Spiros, Purple Cap, Hanger, REF: CL3951; 40" (102 cm) Appx 7.7 ml, Admin Set w/ChemoLock w/Red Cap, 20 Drop In-Line Drip Chamber, 0.2 Micron Filter, Spiros w/Red Cap, Bag Hanger, REF: CL3962; 31" (79 cm) Appx 3.5 ml, Admin Set w/ChemoLock Bag Spike with Additive Port, 20 Drop In-Line Chamber w/15 Micron Filter, Spiros, Purple Cap, Hanger, REF: CL3999

    FDA Enforcement
    Class II ·Ongoing·ICU Medical, Inc.·December 30, 2020

    OEC 6800 Miniview, Image-intensified fluoroscopic x-ray system used during diagnostic, surgical and interventional procedures. Designed to provide the physician with general fluoroscopic visualization of the patient including but not limited to surgical orthopedic and extremity imagine. The device is not intended for whole-body pediatric imaging.

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