BEUDAMED
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    SPLITTABLE SHEATH INTRODUCER SET

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    De Soutter Medical

    FDA UDI
    DE SOUTTER MEDICAL LIMITED·05051471122819·K-WIRE - DOUBLE TROCAR 0.6mm DIA x 100mm

    U-RIGHT TD-3124 BLOOD PRESSURE MONITORING SYSTEM

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    MODIFICATION TO ATRIUM MEDICAL CORPORATION CLEARWAY PTFE BALLOON CATHETER

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    INTRINSIC

    FDA Adverse Event
    Injury ·MEDTRONIC MED REL, INC.·Product code LWS·December 13, 2010

    ASSURITY PLUS DR RF

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL, INC., CRMD·Product code DXY·July 8, 2014

    LIFEVEST WCD 4000 SYSTEM

    FDA Adverse Event
    Malfunction ·ZOLL LIFECOR CORPORATION·Product code MVK·December 7, 2012

    BioGX SARS-CoV-2 Reagents for BD MAX System-IVD PCR test intended for the qualitative detection of nucleic acid from the SARS-CoV-2 in nasopharyngeal specimens Catalog Number: 444213

    FDA Enforcement
    Class II ·Terminated·Becton Dickinson & Co.·April 21, 2021

    TRULIANT Knee System including TRULIANT Tibial Inserts, also labeled as the following: a. TRULIANT CR Tibial Inserts; b. TRULIANT CR Slope + Tibial Inserts; c. TRULIANT CR Slope ++ Tibial Inserts; d. TRULIANT CRC Tibial Inserts; e. TRULIANT PS Tibial Inserts; f. TRULIANT PSC Tibial Inserts. NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.

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