BEUDAMED
    20 results · 8ms · Sources: EU EUDAMED, US FDA

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    Filters Classification: Class Ii × Status: Terminated × Clear all

    INFX-8000V Fluoroscopic X-Ray Systems; INFINIX CF-I/BP PLUS CARDIAC SYSTEM

    FDA Enforcement
    Class II ·Terminated·Toshiba American Medical Systems Inc·March 14, 2018

    INFX-8000V Interventional Angiography System. CAT-880B catheterization table. Cardiac and Vascular intervention with fluoroscopic and fluorographic images. For the USA and Canada the system is registered as lnfinix CF-i or lnfinix VF-i, for national regulations. INFX-8000V series includes a floor mounted multi-axis positioner.

    FDA Enforcement
    Class II ·Terminated·Toshiba American Medical Systems Inc·April 15, 2015

    TRIATHLON FEMORAL DISTAL AUGMENT 15MM - SIZE 2 LEFTTriathlon Femoral Distal Augments are used with Triathlon TS Femoral Components during revision Total Knee Arthroplasty (TKA) and with Triathlon Primary PS Femoral Components during TKA to address distal femoral defects. (See attached IFU (IFU_Triathlon Total Knee_QIN 4376 Rev AB) Catalog # 5542-A-201 - Product Usage:

    FDA Enforcement
    Class II ·Terminated·Howmedica Osteonics Corp.·October 9, 2019

    Olympus, Model No. GIF-H180, flexible scope, large diameter, video gastroscope

    FDA Enforcement
    Class II ·Terminated·Integrated Medical Systems Inc·March 2, 2016

    Olympus, Model No. GIF-Q160, flexible scope, large diameter, video gastroscope

    FDA Enforcement
    Class II ·Terminated·Integrated Medical Systems Inc·March 2, 2016

    Olympus, Model No. GIF-H180J, flexible scope, large diameter, video gastroscope

    FDA Enforcement
    Class II ·Terminated·Integrated Medical Systems Inc·March 2, 2016

    Olympus, Model No. GIF-Q180,flexible scope, large diameter, video gastroscope

    FDA Enforcement
    Class II ·Terminated·Integrated Medical Systems Inc·March 2, 2016

    Olympus, Model No. GIF-Q140, flexible scope, large diameter, video gastroscope

    FDA Enforcement
    Class II ·Terminated·Integrated Medical Systems Inc·March 2, 2016

    Olympus, Model No. GIF-XQ140, flexible scope, large diameter, video gastroscope

    FDA Enforcement
    Class II ·Terminated·Integrated Medical Systems Inc·March 2, 2016

    Olympus, Model No. GIF-160, flexible scope, large diameter, video gastroscope

    FDA Enforcement
    Class II ·Terminated·Integrated Medical Systems Inc·March 2, 2016

    Olympus, Model No. GIF-XP160, flexible scope, large diameter, video gastroscope

    FDA Enforcement
    Class II ·Terminated·Integrated Medical Systems Inc·March 2, 2016

    Olympus, Model No. GIF-140, flexible scope, large diameter, video gastroscope

    FDA Enforcement
    Class II ·Terminated·Integrated Medical Systems Inc·March 2, 2016

    PENTAX Upper/Lower G.I. Endoscope OF-B130 and OF-B194 Gas/Water Feeding Valve

    FDA Enforcement
    Class II ·Terminated·Pentax Medical Company·August 27, 2014

    Olympus GIF-H180J Gastrointestinal Videoscope - Product Usage: These endoscopes are intended for use in endoscopic diagnosis and treatment within the gastrointestinal tract.

    FDA Enforcement
    Class II ·Terminated·Olympus Corporation of the Americas·March 20, 2019

    Fujifilm Medical Endoscope for the duodenum and upper G.I. tract. ED-530XT, ED-250XT5, ED-250XL5, ED-450XT5, and ED-450XL5 Endoscope Operation Manuals.

    FDA Enforcement
    Class II ·Terminated·Fujifilm Medical Systems U.S.A., Inc.·September 23, 2015

    PRN 50-M+, GE part number 2062759-001, manufacturer part number 600-23310-01 Product Usage: The PRN 50M+ Paper Chart Recorder thermally records patient data on a paper strip. This device is intended for use under direct supervision of a licensed health care practitioner. This device is not intended for home use.

    FDA Enforcement
    Class II ·Terminated·Gsi Group Inc·March 2, 2016

    Fujifilm Medical Systems Duodenoscope, Model Numbers ED-200XU, ED-200XT, ED-250XT, ED-310XU, ED-420XL, ED-410XT, ED-410XU, ED-450XL, and ED-450XT. Medical endoscope for the duodenum and upper G.I. tract. Open elevator wire channel duodenoscopes.

    FDA Enforcement
    Class II ·Terminated·Fujifilm Medical Systems U.S.A., Inc.·December 23, 2015

    Drop Arm Versamode"

    FDA Enforcement
    Class II ·Terminated·Gf Health Products·April 14, 2021

    Lumex, Patriot Full Electric Homecare Bed, & Patriot LX Full Electric Homecare Bed containing the Okin Dumat 3 Head/Foot Motors. Description Part Number Motor and Pendant Patriot Full Electric 120V 690-3001-943 / 690-7001-943 Boxed Full Electric 220V Motor 690-3220-943 Motor and Pendant Patriot LX Full Electric 120V 690-8004-912

    FDA Enforcement
    Class II ·Terminated·GF Health Products, Inc·December 21, 2016

    Zenith Slide W-I-D-E Long Term Care Bed, Model(s) APS98674, APS9867406, APS986741, APS986742, ZG58674, ZG78674, ZZ78674, ZZ98674, and ZZ98774. Designed for use within an institutional healthcare environment (i.e. assisted living, skilled nursing, transitional care, rehabilitation centers, etc.).

    FDA Enforcement
    Class II ·Terminated·GF Health Products, Inc./d.b.a.Basic American Metal Products·September 24, 2014