BEUDAMED
    10 results · 17ms · Sources: EU EUDAMED, US FDA

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    EMIT(R) II COCAINE METABOLITE ASSAY

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    TI SCREW ES

    FDA UDI
    Biomet Orthopedics, LLC·00880304404380·

    INTRAUTERINE INSEMINATION (IUI) CATHETER

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    DERMAGRIP POWDERFREE POLYMER COATED LATEX EXAMINATION GLOVE WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAM OR LESS)

    FDA 510(k)
    FDA Class 1 ·General Hospital

    QUADROX-I OXYGENATOR

    FDA Adverse Event
    Malfunction ·MAQUET CARDIOPULMONARY AG·Product code DTZ·May 9, 2014

    JAGWIRE

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC - MIAMI·Product code EZB·November 18, 2010

    DURATA STS OPTIM ACTIVE FIXATION, DF-4 CONNECTOR

    FDA Adverse Event
    Injury ·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

    DxI 600 Access Immunoassay Analyzer W/Spot B, Part Number A71460

    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