BEUDAMED
    9 results · 36ms · Sources: EU EUDAMED, US FDA

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    BAXTER DUPLOSPRAY MIS APPLICATOR

    FDA 510(k)
    FDA Class 2 ·General Hospital

    CANDELA SPTL-1E PULSED DYE LASER

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

    GENERIC BLOOD GLUCOSE TEST STRIP

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    E500 VENTILATOR SYSTEM

    FDA Adverse Event
    Injury ·NEWPORT MEDICAL INSTRUMENTS, INC·Product code CBK·July 11, 2016

    POWERED WHEELCHAIR

    FDA Adverse Event
    Malfunction ·INVACARE TAYLOR STREET·Product code ITI·April 16, 2013

    INTERLINK T-CON EXT SET/MICRO-BORE W/MLL ADT DN003

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - AIBONITO·Product code FPA·April 18, 2011

    LIFEVEST WCD 3000 SYSTEM

    FDA Adverse Event
    Malfunction ·ZOLL LIFECOR CORPORATION·Product code MVK·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