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

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    Filters Classification: Class Ii × Regulation: Us FDA × Clear all

    Cobas b 221 (versions 5 and 6) Blood Gas and Electrolytes Analyzer

    FDA Enforcement
    Class II ·Terminated·Roche Diagnostics Operations, Inc.·February 11, 2015

    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

    Stanbio AC power adapter for the HemoPoint H2 meter, Model G3000 series. The firm name on the label for the HemoPoint H2 shows Manufactured by EKF-diagnostic GmbH, Germany.

    FDA Enforcement
    Class II ·Terminated·Stanbio Laboratory, LP·September 5, 2018

    CombiDiagnost GCF, Software v. 1.0.5, Product Code 709030 - Product Usage: Xray system, diagnostic, fluoroscopic, general purpose.

    FDA Enforcement
    Class II ·Ongoing·Philips Medical Systems Gmbh, DMC·February 26, 2020

    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

    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

    EVIS EXERA II Gastrointestinal Videoscope-indicated for use within the upper digestive tract (including the esophagus, stomach, and duodenum). Model: GIF-HQ190

    FDA Enforcement
    Class II ·Ongoing·Olympus Corporation of the Americas·June 29, 2022

    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