BEUDAMED
    20 results · 24ms · Sources: EU EUDAMED, US FDA

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    VENTANA IMAGE ANALYSIS SYSTEM - HER2/NEU

    FDA 510(k)
    FDA Class 2 ·Hematology

    AIW WATER SYSTEM FOR HEMODIALYSIS

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

    LV-1 HEMOSTASIS VALVE, MODEL #6789

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    TSRH® SPINAL SYSTEM

    FDA Adverse Event
    Malfunction ·MEDTRONIC SOFAMOR DANEK·Product code KWP·April 19, 2013

    TSRH SPINAL SYSTEM

    FDA Adverse Event
    Malfunction ·MEDTRONIC ORTHOPEDIC INC.·Product code KWP·December 4, 2009

    M-LNCS DC-I

    FDA Adverse Event
    Malfunction ·MASIMO - 40 PARKER·Product code DQA·November 21, 2016

    M-LNCS DC-I

    FDA Adverse Event
    Malfunction ·MASIMO - 40 PARKER·Product code DQA·November 21, 2016

    TSRH SPINAL SYSTEM

    FDA Adverse Event
    Malfunction ·WARSAW ORTHOPEDIC INC.·Product code KWP·December 4, 2009

    TSRH SPINAL SYSTEM

    FDA Adverse Event
    Malfunction ·WARSAW ORTHOPEDICS·Product code KWP·May 29, 2013

    LNCS DC-I

    FDA Adverse Event
    Malfunction ·MASIMO - 40 PARKER·Product code DQA·March 11, 2017

    RD SET DCI

    FDA Adverse Event
    Malfunction ·MASIMO - 40 PARKER·Product code DQA·February 17, 2017

    PROTECTA XT CRT-D

    FDA Adverse Event
    Injury ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code NIK·April 10, 2013

    M SERIES

    FDA Adverse Event
    Malfunction ·ZOLL MEDICAL CORPORATION·Product code MKJ·May 22, 2008

    MEDTRONIC ANEURX ILIAC STENT GRAFT

    FDA Adverse Event
    Injury ·MEDTRONIC CARDIOVASCULAR SANTA ROSA·Product code MIH·April 6, 2011

    TSRH SPINAL SYSTEM

    FDA Adverse Event
    WARSAW ORTHOPEDIC, INC.·Product code KWP·August 26, 2011

    RAINBOW RC-4

    FDA Adverse Event
    Malfunction ·MASIMO - 40 PARKER·Product code DQA·July 11, 2017

    NATURA

    FDA Adverse Event
    Malfunction ·CONVATEC DOMINICAN REPUBLIC INC·Product code EXE·August 9, 2024

    LNCS TC-I SENSOR

    FDA Adverse Event
    Malfunction ·MASIMO CORPORATION·Product code DQA·August 31, 2015

    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

    OEC 9800; OEC FluoroTrak 9800 Plus; OEC 9800 Plus; OEC 9800 MD Motorized C-arm System, 892.1650 Image-intensified fluoroscopic x-ray system. The OEC 9800 is designed to provide fluoroscopic and spot-film imaging of the patient during diagnostic, surgical and interventional procedures. The system includes features specifically designed for use in diagnostic and interventional cardiac imaging procedures and is also intended for cholangiography, endoscopic, urologic orthopedic, neurologic, vascular, critical care and emergency room procedures. It may be used for other imaging applications at the physician's discretion.

    FDA Enforcement
    Class I ·Terminated·GE OEC Medical Systems, Inc·August 1, 2012