BEUDAMED
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    REVOLUTION XR/D DIGITAL RADIOGRAPHIC IMAGING SYSTEM

    FDA 510(k)
    FDA Class 2 ·Radiology

    Zirlux

    FDA UDI
    HENRY SCHEIN, INC.·H65890123890·Zirlux Shading Liquid - Dentin, C1, 100ml

    FOSTER GRANT

    FDA UDI
    FGX INTERNATIONAL INC.·00193033423851·

    FOSTER GRANT

    FDA UDI
    FGX INTERNATIONAL INC.·00193033423813·

    FOSTER GRANT

    FDA UDI
    FGX INTERNATIONAL INC.·00193033512074·

    FOSTER GRANT

    FDA UDI
    FGX INTERNATIONAL INC.·00193033423790·

    FOSTER GRANT

    FDA UDI
    FGX INTERNATIONAL INC.·00193033423820·

    FOSTER GRANT

    FDA UDI
    FGX INTERNATIONAL INC.·00193033423837·

    FOSTER GRANT

    FDA UDI
    FGX INTERNATIONAL INC.·00193033423806·

    BAYLIS PAIN MANAGEMENT PROBE/PMP-20-145 AND BAYLIS PAIN MANAGEMENT CONNECTOR CABLE/PMX-BAY-BAY

    FDA 510(k)
    FDA Class 2 ·Neurology

    CHAD THERAPEUTICS OXYMATIC MODEL 401 AND OXYMATIC MODEL 411

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    PRESIDIO 10 - CERECYTE MICROCOIL

    FDA Adverse Event
    Malfunction ·MICRUS ENDOVASCULAR, LLC·Product code HCG·January 9, 2013

    DESARA

    FDA Adverse Event
    Injury ·CALDERA MEDICAL, INC.·Product code FTL·March 7, 2013

    HOMECHOICE PRO

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - LARGO·Product code FKX·March 9, 2011

    LEGEND XT 4 CH COMBO

    FDA Adverse Event
    Other ·CHATTANOOGA GROUP·Product code IPF·March 7, 2008

    Stryker MA204 Bed Model (FL25E) Beds are intended for medical purposes in both general patient care as well as critical care environments. Each uses built-in electric motors and controls which can be operated by the patient, or caregiver, to adjust the height and/or surface contour of the bed.The devices listed above also include movable and latchable side rails which can be lowered or raised to help prevent patient fall and subsequent injury. The Beds include an optional Scale (Models: FL20E, FL25E, FL28C, FL28EX) as well as an optional Bed Exit (1 Zone) or Chaperone

    FDA Enforcement
    Class II ·Terminated·Stryker Medical Division of Stryker Corporation·July 4, 2012

    Medfusion¿ Model 4000 Syringe Infusion Pump, with PharmGuard¿ Server Software (PGS). Sold under the following names: MEDFUSION¿ 4000 Pump V1.0; MEDFUSION¿ 4000 Pump V1.1, v1.1.1, v1.1.2; MEDFUSION¿ 4000 Pump V1.1, V1.1.1, V1.1.2; MEDFUSION¿ 4000 Pump V1.5, V1.5.1; MEDFUSION¿ 4000 Pump V1.5, V1.5.1; MEDFUSION¿ 4000 Pump V1.6, V1.6.1 Product Usage: The pumps are indicated for the following uses: 1. In the administration of fluids requiring precisely controlled infusion rates including blood or blood products, lipids, drugs, antibiotics, enteral solutions and other therapeutic fluids; 2. By the following delivery routes: arterial, epidural, intravenous, intrathecal, subcutaneous, and enteral; 3. By the following delivery modes: continuous, volume/time, mass, body weight, intermittent and bolus.

    FDA Enforcement
    Class II ·Terminated·Smiths Medical ASD Inc.·October 2, 2019