BEUDAMED
    11 results · 19ms · Sources: EU EUDAMED, US FDA

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    ARIA II 125- I-ESTRIOL SYSTEM

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    Millennium

    FDA UDI
    Avalign Technologies, Inc.·00190776187170·YEOMAN RECTAL PUNCH WITH BASKET .

    VITROS

    FDA UDI
    ORTHO-CLINICAL DIAGNOSTICS, INC.·10758750006847·VITROS Chemistry Products C3 Reagent

    NAR

    FDA UDI
    NORTH AMERICAN RESCUE, LLC·00842209135059·

    ANGIOSCULPT PTA SCORING BALLOON CATHETER MODEL 2039-XXYY, 2155-XXYY

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    PlaDuo System

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

    SPECTRUM INFUSION PUMP

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE CORPORATION·Product code FRN·January 8, 2014

    MESH - COMPOSIX

    FDA Adverse Event
    Injury ·DAVOL INC., SUB. C.R. BARD, INC.·Product code FTL·October 12, 2012

    FREESTYLE FLASH

    FDA Adverse Event
    Malfunction ·ABBOTT DIABETES CARE INC, USA·Product code LFR·September 27, 2007

    ACUSON Sequoia Ultrasound Imaging System with Software Version VA25A/B

    FDA Enforcement
    Class II ·Ongoing·Siemens Medical Solutions USA, Inc.·February 9, 2022

    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