BEUDAMED
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    AFFIRM PROCESSOR

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    SMARTSTITCH PERFECTPASSER SYSTEM

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    PHOENIX ISE STANDARD A,B AND C FOR ROCHE/AVL SYSTEMS

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    SYNCHROMED II

    FDA Adverse Event
    Malfunction ·MDT PUERTO RICO OPERATIONS CO., JUNCOS·Product code LKK·November 9, 2010

    ADVANCED CEMENT MIXING BOWL AND 180-GRAM CEMENT CARTRIDGE

    FDA Adverse Event
    Malfunction ·STRYKER INSTRUMENTS-KALAMAZOO·Product code JDZ·July 9, 2014

    ENDURANCE PYRAMID CANE

    FDA Adverse Event
    Malfunction ·R. POON MEDICAL PRODUCTS CO., LTD.·Product code KHY·September 29, 2006

    Covidien Trellis-8 Peripheral Infusion System. Models CVT808015, CVT808025, CVT812015, and CVT812025. The following models are not offered for sale in the US: EVT808015, EVT808025, EVT812015, and EVT812025 Sterile EO. Product Usage: Intended for controlled and selective infusion of physician-specified fluids, including thrombolytics, into the peripheral vasculature.

    FDA Enforcement
    Class I ·Terminated·Covidien·February 11, 2015

    Brand Name: CLEANER BOTTLE Product Name: CLEANER BOTTLE Model/Catalog Number: EG-1000 Software Version: N/A Product Description: CLEANER bottles used with EMS AIRFLOW PROPHYLAXIS MASTER / EMS AIRFLOW ONE devices to clean the water lines. The bottle is placed on the device during cleaning. Component: YES. AIRFLOW PROPHYLAXIS MASTER and AIRFLOW PROPHYLAXIS ONE

    FDA Enforcement
    Class II ·Ongoing·Electro Medical Systems SA·May 1, 2024