BEUDAMED
    10 results · 18ms · Sources: EU EUDAMED, US FDA

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    DIGITAL THERMOMETER CLASSIC TYPE AND FLEXIBLE TYPE

    FDA 510(k)
    FDA Class 2 ·General Hospital

    VINYL TECHNOLOGY, INC.

    FDA registration
    VINYL TECHNOLOGY, INC.·1 product·🇺🇸 United States

    AMBULATORY BLOOD PRESSURE MONITORING SYSTEM, MODEL SE-25M/25P

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    BACTI-SWAB DRY

    FDA 510(k)
    FDA Class 1 ·Microbiology

    TAXUS¿ ELEMENT¿

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC - GALWAY·Product code NIQ·March 27, 2013

    ACRYSOF

    FDA Adverse Event
    Other ·ALCON RESEARCH, LTD/ HUNTINGTON·Product code HQL·February 18, 2011

    PANDUIT CABLE TIE TOOL

    FDA Adverse Event
    Injury ·PANDUIT CORP·Product code MDM·January 14, 2008

    ORCA FOAM STANDARD CUBE 10x10x10 mm, Absorbable Gelatin Sponge Hemostat, USP, REF ORCA FOAM

    FDA Enforcement
    Class II ·Completed·GELITA MEDICAL GMBH·September 28, 2022

    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

    OPTETRAK LOGIC Polyethylene Tibial Inserts, labeled as the following: a. OPTETRAK Logic PS Tibial Inserts, Product Line 02-012-35-XXXX; b. OPTETRAK Logic PSC Tibial Inserts, Product Line 02-012-44-XXXX; c. OPTETRAK Logic CR Tibial Inserts, Product Line 02-012-47-XXXX; d. OPTETRAK Logic CR Slope + Tibial Inserts, Product Line 02-012-48-XXXX; e. OPTETRAK Logic CR Slope ++ Tibial Inserts, Product Line 02-012-49-XXXX; f. OPTETRAK Logic CRC Tibial Inserts, Product Line 02-012-51-XXXX; g. OPTETRAK Logic CC Tibial Inserts, Product Line 02-012-65-XXXX; Affected 510(k) numbers include: K033883, K132161, K093360, K110547, K111400, K121307, K123342, K150890. NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·October 13, 2021