BEUDAMED
    10 results · 27ms · Sources: EU EUDAMED, US FDA

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    POTASSIUM REAGENT SET

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    TI SCREW ES

    FDA UDI
    Biomet Orthopedics, LLC·00880304404335·

    ESL SPINAL SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    MASIMO SET RADICAL PULSE OXIMETER WITH SATSHARE AND LNOP SERIES OF SENSORS AND CABLES, MODEL RADICAL, LNOP-ADT, LNOP-PDT

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    11.5FX 15CM HEMO-CATH

    FDA Adverse Event
    Malfunction ·MEDCOMP·Product code LFJ·May 9, 2014

    INTELLIVUE MULTI MEASUREMENT SERVER X2

    FDA Adverse Event
    Injury ·PHILIPS MEDICAL SYSTEMS·Product code MHX·November 12, 2010

    TVL ADX

    FDA Adverse Event
    Malfunction ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code NVY·January 8, 2013

    Beckman Coulter UniCel DxI 600, Part Numbers: A71460, A30260; Photometric Chemistry Analyzer

    FDA Enforcement
    Class II ·Ongoing·Beckman Coulter, Inc.·November 12, 2025

    UniCel DxI 600 Access Immunoassay Analyzer, Part Number A30260

    FDA Enforcement
    Class II ·Ongoing·Beckman Coulter, Inc.·August 13, 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