BEUDAMED
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    COBAS INTEGRA REAGENT CASSETTE FOR RHEUMATOID FACTOR II

    FDA 510(k)
    FDA Class 2 ·Immunology

    Impella

    FDA UDI
    Abiomed, Inc.·00813502012729·ABMD Intro Kit, 14Fr x Short, Pkgd US

    PowerPICC SOLO

    FDA UDI
    Bard Access Systems, Inc.·00801741104152·Catheter Placement Kit

    Creation Willi Geller

    FDA UDI
    KLEMA Dentalprodukte GmbH·ECWG0005341·CC/ Dentine D-A3,5

    Non-Telescopic PenEvac

    FDA UDI
    I.C. MEDICAL, INC.·00817688020738·

    TUFF TT IMPLANT

    FDA Adverse Event
    Injury ·NORIS MEDICAL LTD·Product code DZE·July 7, 2024

    TUFF TT IMPLANT

    FDA Adverse Event
    Injury ·NORIS MEDICAL LTD·Product code DZE·June 24, 2024

    FlowLogic Assert

    FDA UDI
    SONENDO, INC.·00810209420499·FlowLogic Assert Shaping File 13/.02, 25mm

    Well at Walgreens

    FDA UDI
    WALGREEN CO.·00311917167596·Heating pad

    IMPACT MODULAR TOTAL HIP SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    OIS-STAND ALONE DIAGNOSTIC ULTRASOUND SYSTEM

    FDA 510(k)
    FDA Class 2 ·Radiology

    VENTED HUMIDIFICATION CHAMBER

    FDA Adverse Event
    Malfunction ·FISHER & PAYKEL HEALTHCARE LTD·Product code BTT·March 12, 2013

    TRUWAVE DISPOSABLE PRESSURE TRANSDUCER

    FDA Adverse Event
    Malfunction ·EDWARDS LIFESCIENCES DR·Product code DXO·February 24, 2011

    ATLAS20CM

    FDA Adverse Event
    Malfunction ·COVIDIEN LP (US SURGICAL)·Product code GEI·February 11, 2008

    INSET

    FDA Adverse Event
    Malfunction ·UNOMEDICAL UM-D·Product code FPA·March 30, 2026

    PROXIMATE*SKIN STPLR (EXACT CODE UNKNOWN)

    FDA Adverse Event
    Injury ·ETHICON ENDO-SURGERY, LLC.·Product code GDT·March 20, 2018

    Model 3300 LATITUDE(TM) Programming System Product Usage - The Boston Scientific LATITUDE Programming System is intended for use in hospital and clinical environments to communicate with Boston Scientific implantable systems. The software in use controls all communication functions for the Pulse Generator (PG). Detailed software applications instructions can be found in the associated product literature for the PG being interrogated.

    FDA Enforcement
    Class II ·Terminated·Boston Scientific Corporation·October 3, 2018

    BrightView SPECT (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography X-ray systems and Diagnostic Imaging systems.

    FDA Enforcement
    Class II ·Terminated·Philips Medical Systems (Cleveland) Inc·June 17, 2015

    BrightView SPECT gamma camera for Emission Computed Tomography, Philips Medical Systems, Cleveland, OH 44143 BrightView SPECT is a gamma camera designed for single or dual detector nuclear imaging accommodating a broad range of emission computed tomography Emission Computed Tomography (ECT) studies.

    FDA Enforcement
    Class II ·Terminated·Philips Medical Systems (Cleveland) Inc·June 12, 2013

    Smiths Medical, Medfusion¿ Syringe Infusion Pump, Model 4000, Software Version V1.0 & V1.1, Reorder Numbers 4000-0100-50, 4000-0100-95, 4000-0101-50, 4000-0101-51, and 4000-0101-78. Designed for use in care areas for the administration of fluids requiring precisely controlled infusion rates.

    FDA Enforcement
    Class I ·Terminated·Smiths Medical ASD, Inc.·August 8, 2012