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

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    DIMENSION VISTA SYSTEM ECSTASY CALIBRATOR, MODEL KC520

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    REMEL

    FDA UDI
    REMEL, INC.·00848838008719·Phenylalanine Agar (slant) 20/PK

    AVITA TSO/TS1 INFRARED EAR THERMOMETER

    FDA 510(k)
    FDA Class 2 ·General Hospital

    MEDISENSE PRECISION EASYBLOOD GLUCOSE MONITORING SYSTEM, MEDISENSE OPTIUM EASYBLOOD GLUCOSE MONITORING SYSTEM

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    RELIANCE C DOUBLE SIDED RASP 7MM

    FDA Adverse Event
    Malfunction ·STRYKER SPINE-FRANCE·Product code LXH·October 25, 2016

    EVOLUT FX DCS

    FDA Adverse Event
    Injury ·MEDTRONIC HEART VALVES DIVISION·Product code NPT·July 1, 2025

    PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE

    FDA Adverse Event
    Injury ·MPRI·Product code LWP·April 16, 2013

    PUMP IN STYLE ADVANCED

    FDA Adverse Event
    Malfunction ·MEDELA, INC.·Product code HGX·March 17, 2011

    RESTORATION 8" HA HIP STEM

    FDA Adverse Event
    Malfunction ·STRYKER ORTHOPAEDICS MAHWAH·Product code KWY·June 13, 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

    CADD¿- Solis Ambulatory Infusion Pump, Model 2111 & 2112, Version 1.0, Version 2.0 and Version 3.0 & Model 2120, Version 1.0. Provide measured drug therapy to patients in hospital or outpatient settings.

    FDA Enforcement
    Class II ·Terminated·Smiths Medical ASD, Inc.·June 24, 2015

    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