BEUDAMED
    35 results · 7ms · Sources: EU EUDAMED, US FDA

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    Filters FDA Enforcement × Classification: Class Ii × Clear all

    Gastrointestinal videoscope-indicated for use within the upper digestive tract (including the esophagus, stomach, and duodenum). Model Numbers: GIF-1TH190, GIF-1TQ160, GIF-2T160, GIF-2TH180, GIF-H170, GIF-H180, GIF-H180J, GIF-H190, GIF-HQ190, GIF-LV1, GIF-N180, GIF-Q150, GIF-Q160Z, GIF-Q180, GIF-XP180N, GIF-XP190N, GIF-XTQ160. 510(k) Numbers: K112680, K954451, K051645, K100584, K111756, K011151, K123317.

    FDA Enforcement
    Class II ·Ongoing·Aizu Olympus Co., Ltd.·November 29, 2023

    Cholesterol Test

    FDA Enforcement
    Class II ·Ongoing·GET TESTED INTERNATIONAL AB·December 10, 2025

    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

    EVIS EXERA III Gastrointestinal Videoscope GIF-1TH190. Model Number: GIF-1TH190

    FDA Enforcement
    Class II ·Ongoing·Olympus Corporation of the Americas·December 11, 2024

    Brand Name: EVIS EXERA III Gastrointestinal Videoscope GIF-1TH190 Product Name: Olympus GIF-1TH190 Model/Catalog Number: GIF-1TH190 Software Version: N/A Product Description: This instrument is intended to be used with an Olympus video system center, light source, documentation equipment, monitor, EndoTherapy accessories (such as biopsy forceps), and other ancillary equipment for endoscopy and endoscopic surgery.

    FDA Enforcement
    Class II ·Ongoing·Olympus Corporation of the Americas·November 27, 2024

    GIF-HQ190, EVIS EXERA III GASTROINTESTINAL VIDEOSCOPE

    FDA Enforcement
    Class II ·Ongoing·Aizu Olympus Co., Ltd.·December 6, 2023

    GIF-H190, EVIS EXERA III GASTROINTESTINAL VIDEOSCOPE

    FDA Enforcement
    Class II ·Ongoing·Aizu Olympus Co., Ltd.·December 6, 2023

    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 Gastrointestinal Videoscope, Model/Catalog Number: GIF-1100

    FDA Enforcement
    Class II ·Ongoing·Olympus Corporation of the Americas·October 30, 2024

    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