BEUDAMED
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    AXIOM ARISTOS FX (MULTI PURPOSE RADIOGRAPHY SYSTEM)

    FDA 510(k)
    FDA Class 2 ·Radiology

    AXIOM ARISTOS VX PLUS

    FDA Adverse Event
    Injury ·SIEMENS SHANGHAI MEDICAL EQUIPMENT LTD·Product code MQB·April 7, 2021

    EZ2C

    FDA UDI
    FGX INTERNATIONAL INC.·00193033520437·

    EZ2C

    FDA UDI
    FGX INTERNATIONAL INC.·00193033520444·

    EZ2C

    FDA UDI
    FGX INTERNATIONAL INC.·00193033520451·

    EZ2C

    FDA UDI
    FGX INTERNATIONAL INC.·00193033520420·

    EZ2C

    FDA UDI
    FGX INTERNATIONAL INC.·00193033520413·

    EZ2C

    FDA UDI
    FGX INTERNATIONAL INC.·00193033520406·

    EPS320 CARDIAC STIMULATOR

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    FOCUS DAILIES PROGRESSIVES

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    MECHANICAL WALKER, ROLLATOR

    FDA Adverse Event
    DANYANG MAXTHAI MEDICAL EQUIPMENT·Product code ITJ·March 20, 2013

    CANNULATED COMPRESSION SCREW

    FDA Adverse Event
    Malfunction ·STRYKER OSTEOSYNTHESIS FREIBURG·Product code HRS·February 4, 2011

    LOW PROFILE EXTENSION

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code MHY·March 14, 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 Syringe Pump Model: Model 4000-0100-50, Model 4000-0101-249, Model 4000-0101-50, Model 4000-0101-51, Model 4000-0101-78, Model 4000-0105-249, Model 4000-0105-51, Model 4000-0105-78, Model 4000-0106-00, Model 4000-0106-01, Model 4000-0106-231

    FDA Enforcement
    Class I ·Ongoing·Smiths Medical ASD Inc.·June 29, 2022

    HeartMate 3 Left Ventricular Assist System (LVAS): 1. HeartMate 3 Sealed Outflow Graft with Bend Relief, Investigational Device Exemption (IDE) 2. HeartMate 3 Sealed Outflow Graft with Bend Relief, US 3. HeartMate 3 Sealed Outflow Graft with Bend Relief, OUS 4. HeartMate 3 LVAS Implant Kit, IDE 5. HeartMate 3 LVAS Implant Kit, US 6. HeartMate 3 LVAS Implant Kit, OUS HeartMate 3 Left Ventricular Assist System: The HeartMate 3 LVAS is designed to provide therapeutic benefit to those affected with advanced heart failure. The LVAS assumes some or all of the workload of the left ventricle. The LVAS features a Left Ventricular Assist Device (LVAD), a blood pump intended for long-term implantation in such patients, an extracorporeal Controller, plus supporting equipment.

    FDA Enforcement
    Class I ·Ongoing·Thoratec Corp.·March 27, 2024