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    HAKKI URINARY CATHETER; SIZE 14, 16, 18, 20, 22, 24, 26 FRENCH

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

    ILIZAROV SYSTEMS

    FDA UDI
    Smith & Nephew, Inc.·03596010454522·TWISTED PLATE 45MM

    Tasso+ Convenience Kit

    FDA UDI
    Tasso Inc.·00850038691028·

    Tasso+ Convenience Kit

    FDA UDI
    Tasso Inc.·00850038691011·

    ILIZAROV SYSTEMS

    FDA UDI
    MEDICALPLASTIC SRL·08033201841679·TWISTED PLATE 2 HOLES

    JOBST Elvarex

    FDA UDI
    BSN-Jobst GmbH·04019702349467·Elvarex 2/Knee High/Closed Toe/Dotted 2,5 cm Si...

    iTotal PS

    FDA UDI
    Conformis, Inc.·M572RPS0101900121·ITOTAL PS - IPOLY - 19MM INSERT – LEFT or right...

    iTotal Identity Posterior Stabilized Knee Replacement System

    FDA UDI
    Conformis, Inc.·M572RPS0101900031·ITOTAL IDENTITY PS TIBIAL INSERT + TRIAL, IPOLY...

    iTotal PS

    FDA UDI
    Conformis, Inc.·M572RPS0101900111·ITOTAL PS - IPOLY - 19MM INSERT - LEFT or right...

    iTotal Identity CR

    FDA UDI
    Conformis, Inc.·M572RCR0101900141·ITOTAL IDENTITY CR TIBIAL INSERT, NO TRIAL, IPO...

    iTotal Identity CR

    FDA UDI
    Conformis, Inc.·M572RCR0101900041·ITOTAL IDENTITY CR TIBIAL INSERT + TRIAL, IPOLY...

    ENZYME IMMUNOASSAY ANTI-SSDNA ANTIBODY TEST

    FDA 510(k)
    FDA Class 2 ·Immunology

    GLUCOSE (HEXOKINASE)

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    EQUINOXE

    FDA Adverse Event
    Injury ·EXACTECH, INC.·Product code KWT·July 2, 2019

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·May 9, 2013

    ANIMAS VIBE

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·September 19, 2014

    SEVEN CONTINUOUS GLUCOSE MONITORING SENSOR

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code MDS·May 2, 2011

    SMARTXIDE 50 HS

    FDA Adverse Event
    Malfunction ·EL.EN. ELECTRONIC ENGINEERING S.P.A.·Product code GEX·October 30, 2023

    AUTOSOFT 30

    FDA Adverse Event
    Malfunction ·UNOMEDICAL UM-D·Product code FPA·January 28, 2025

    AirFlow, Small Adult Resuscitator, AF5000 Series, Single use, Manufactured by: Ventlab Corporation, 155 Boyce Drive, Mockville, NC 27028 The Disposable Resuscitators with optional built-in pressure monitor is intended to provide respiratory support in the presence of reversible apnea, commonly associated with cardiopulmonary arrest.

    FDA Enforcement
    Class I ·Terminated·Ventlab Corporation·November 7, 2012