BEUDAMED
    15 results · 29ms · Sources: EU EUDAMED, US FDA

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    FREELITE HUMAN KAPPA AND LAMBDA FREE KITS FOR USE ON THE SPAPLUS ANALYZER

    FDA 510(k)
    FDA Class 2 ·Immunology

    SYSMEX UF-50

    FDA 510(k)
    FDA Class 2 ·Hematology

    ACCESS ALERT GAUGE

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

    INTRALASE FS2

    FDA Adverse Event
    Injury ·ABBOTT MEDICAL OPTICS·Product code HNO·November 21, 2013

    VISX EXCIMER LASER

    FDA Adverse Event
    Injury ·AMO MANUFACTURING USA LLC·Product code LZS·November 5, 2010

    INTRALASE FS2

    FDA Adverse Event
    Injury ·ABBOTT MEDICAL OPTICS·Product code HNO·August 20, 2013

    INTRALASE FS2

    FDA Adverse Event
    Injury ·ABBOTT MEDICAL OPTICS·Product code HNO·October 30, 2013

    OT VERIO PRO METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·April 16, 2013

    2800

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·April 12, 2011

    ACCU-CHEK COMFORT CURVE TEST STRIPS

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code LFR·June 18, 2008

    RADIFOCUS GLIDEWIRE ADVANTAGE

    FDA Adverse Event
    Malfunction ·TERUMO MEDICAL CORPORATION·Product code DQX·August 30, 2023

    RADIFOCUS GLIDEWIRE ADVANTAGE

    FDA Adverse Event
    Malfunction ·TERUMO CORPORATION, ASHITAKA·Product code DQX·December 23, 2022

    RADIFOCUS GLIDEWIRE ADVANTAGE

    FDA Adverse Event
    Injury ·TERUMO CORPORATION, ASHITAKA·Product code DQX·March 19, 2025

    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