BEUDAMED
    20 results · 21ms · Sources: EU EUDAMED, US FDA

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    NELSON ELECTROSURGICAL UNIT, MODEL GN640

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    UNBRANDED

    FDA UDI
    FGX INTERNATIONAL INC.·00193033568866·

    UNBRANDED

    FDA UDI
    FGX INTERNATIONAL INC.·00193033568859·

    UNBRANDED

    FDA UDI
    FGX INTERNATIONAL INC.·00193033568835·

    UNBRANDED

    FDA UDI
    FGX INTERNATIONAL INC.·00193033568828·

    UNBRANDED

    FDA UDI
    FGX INTERNATIONAL INC.·00193033568842·

    UNBRANDED

    FDA UDI
    FGX INTERNATIONAL INC.·00193033568873·

    UniTip Catheter

    FDA UDI
    Unisensor AG·07640172973868·

    UniTip Catheter

    FDA UDI
    Unisensor AG·07640172973783·

    LEAD BLOCKS

    FDA 510(k)
    FDA Class 2 ·Radiology

    ARTHREX BIO-TRANSFIX

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    PLATE, FIXATION, BONE

    FDA Adverse Event
    Injury ·SYNTHES USA·Product code HRS·November 3, 2014

    UNKNOWN NEXGEN TIBIAL TRAY

    FDA Adverse Event
    Injury ·ZIMMER, INC.·Product code JWH·June 15, 2017

    OT PING METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·March 21, 2013

    ACCENT DR RF

    FDA Adverse Event
    Malfunction ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code DXY·March 10, 2011

    ICY HOT HEAT THERAPY PATCH

    FDA Adverse Event
    Other ·CHATTEM, INC.·Product code IMD·March 13, 2008

    ARCHITECT TOTAL PSA

    FDA Adverse Event
    Malfunction ·ABBOTT IRELAND·Product code LTJ·August 28, 2014

    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

    Ultraview SL Command Modules, Model 91496-M, upgraded with the Masimo SpO2 Option. Product Usage: The Spacelabs Multi-parameter Module is intended for use with the Patient Care Management System (PCMS) to acquire, monitor, and process various clinical parameters from an adult or neonate/infant populations in any type of clinical environment other than home use. Physiological parameters that may be monitored include ECG with arrhythmia detection, respiration, invasive and noninvasive blood pressure, temperature, oxygen saturation (Sp02) and cardiac output. Acquired data may then be communicated to all information network for display, recording, editing and analysis.

    FDA Enforcement
    Class II ·Terminated·Spacelabs Healthcare Inc·May 6, 2015

    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