BEUDAMED
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    KEMTROL SERUM CONTROL-NORMAL

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    Integra® Total Foot System

    FDA UDI
    Ascension Orthopedics, Inc.·10381780119487·The Integra Total Foot System interpositioning ...

    Total Foot System 2

    FDA UDI
    Smith & Nephew, Inc.·00885556838150·INTERPOSITIONING PLATE. 8MM STEM

    Corneal Trephine

    FDA UDI
    KATENA PRODUCTS, INC.·00841668112779·BARRON VACUUM PUNCH 8.0MM

    CLICKFINE PEN NEEDLE

    FDA 510(k)
    FDA Class 2 ·General Hospital

    OBC BONE ANCHORED HEARING AID SYSTEM

    FDA 510(k)
    FDA Class 2 ·Ear, Nose, Throat

    AUTOGEN

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code NIK·February 13, 2024

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    FDA Adverse Event
    Injury ·AV-TEMECULA-CT·Product code MGB·October 23, 2012

    9800

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·December 30, 2013

    PERFECTO2 V WITH SENSOR 9153650799

    FDA Adverse Event
    Malfunction ·INVACARE FLORIDA OPERATIONS·Product code CAW·May 28, 2015

    Product Label - ACUSON Sequoia *** Power Input: 100-240V~, 13.0-5.4A, 50-60Hz *** (240)11148775 Model User Manual states - ACUSON Sequoia Diagnostic Ultrasound Systems

    FDA Enforcement
    Class II ·Ongoing·Siemens Medical Solutions USA, Inc.·April 7, 2021

    paraPAC plus 310 ventilator kit with internal PEEP and CPAP, Item Number P310N

    FDA Enforcement
    Class I ·Ongoing·Smiths Medical ASD Inc.·October 2, 2024

    smiths medical Pneupac paraPAC plus 310 ventilator kit with PEEP and CPAP, REF P310NUS

    FDA Enforcement
    Class I ·Ongoing·Smiths Medical ASD Inc.·March 27, 2024