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

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    Filters Classification: Class Ii ×

    EVIS EXERA BF-XT160 Bronchofibervideoscope, Model No. BF-XT160

    FDA Enforcement
    Class II ·Terminated·Olympus Corporation of the Americas·September 29, 2021

    Custom Waste Management Kit: REF: K10-00353K, K10-01603C, K10-01694Q, K10-05159B, K10-05743, K10-05825AP

    FDA Enforcement
    Class II ·Ongoing·Merit Medical Systems, Inc.·August 20, 2025

    CME America T-Syringe Pump - T34 - Product Usage: infusion of medications or fluids requiring continuous or intermittent delivery at precisely-controlled infusion rates through clinically acceptable routes of administration, including intravenous, subcutaneous, percutaneous, intra-arterial, epidural, in close proximity to nerves, and into an intra-operative site (soft tissue/body cavity/surgical wound site).

    FDA Enforcement
    Class II ·Terminated·CME America, LLC·December 9, 2020

    1202 Flex Focus Ultrasound System, cart models UA1214 and UA1814, used with: Flex Focus 200, Flex Focus 300, Flex Focus 400, Flex Focus 500, Flex Focus 700, Flex Focus 800; System, Imaging, Pulsed Doppler, Ultrasonic

    FDA Enforcement
    Class II ·Ongoing·B-K Medical A/S·November 12, 2025