BEUDAMED
    14 results · 26ms · Sources: EU EUDAMED, US FDA

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    OMNIVIEW DIGITAL RADIOLOGY IMAGING SYSTEM

    FDA 510(k)
    FDA Class 1 ·Radiology

    GRADIA®

    FDA UDI
    Gc America Inc.·D0479011181·GRADIA PLUS LP-D, 0.8ml, 1pc

    Welch Allyn, Inc.

    FDA UDI
    WELCH ALLYN, INC.·00732094288735·SPIROMETER KIT FOR CONNEX CARDIO

    Integra®

    FDA UDI
    INTEGRA NEUROSCIENCES IMPLANT (FRANCE)·10381780033172·The 46 cm Peritoneal Introducer Sheath is desig...

    Welch Allyn, Inc.

    FDA UDI
    WELCH ALLYN, INC.·00732094296266·WELCH ALLYN USB DATA CABLE 1.8M

    Elite® Bondable Buccal Tubes

    FDA UDI
    Ortho Organizers, Inc.·00190707070991·Elite®.022 U6L DBT/HK -10T DB

    MODIFICATION TO LIPOPROTEIN (A) SPQ III ANTIBODY REAGENT SET

    FDA 510(k)
    FDA Class 2 ·Immunology

    FOOT AND HAND MOTION SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    QUADRA ASSURA DR CRT-D

    FDA Adverse Event
    Malfunction ·ST. JUDE MEDICAL, INC., CRMD·Product code NIK·June 30, 2014

    ELEVATE PROLAPSE REPAIR SYSTEM

    FDA Adverse Event
    Injury ·AMERICAN MEDICAL SYSTEMS, INC.·Product code FTL·January 3, 2013

    LTV

    FDA Adverse Event
    Malfunction ·CAREFUSION 203, INC.·Product code CBK·November 10, 2010

    SYRINGE S2 20ML 18GA 1-1/2IN BD

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON, S.A.·Product code FMF·January 9, 2020

    Z-800 Infusion System. Intended to provide intravenous infusion of parenteral fluids, blood, and blood products to a patient.

    FDA Enforcement
    Class I ·Ongoing·Zyno Medical LLC·June 18, 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