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

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    PHARMAJET STRATIS 0.5 ML NEEDLE-FREE INJECTION SYSTEM MODEL 501-01, STRATIS INJECTOR CATALOG 501-10, STRATIS RESET STATI

    FDA 510(k)
    FDA Class 2 ·General Hospital

    A Series

    FDA UDI
    Respironics, Inc.·00606959032026·A Series System One Heated Humidifier, Internat...

    MicroSelectron Digital

    FDA UDI
    Nucletron B.V.·08717213033504·Coupling Treatment Tube for 4F Flexibles (17)

    Surgical Instrument

    FDA UDI
    Jeil Medical Corporation·08800089448920·

    Zavation

    FDA UDI
    Zavation LLC·00842166181731·17mm Dilator

    LUTE; CORE

    FDA 510(k)
    FDA Class 2 ·Dental

    SEDECAL MOBILE DIGITAL DIAGNOSTIC X-RAY

    FDA 510(k)
    FDA Class 2 ·Radiology

    ARTERIAL CANNULA 20G/45MM

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON·Product code FOZ·May 10, 2024

    TRIMA ACCEL

    FDA Adverse Event
    Malfunction ·TERUMO BCT·Product code GKT·May 14, 2013

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC MINIMED·Product code OYC·September 23, 2014

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·June 2, 2011

    Artis Q.zen ceiling, Model Number 10848354

    FDA Enforcement
    Class II ·Ongoing·Siemens Medical Solutions USA, Inc·April 27, 2022

    Artis Q floor- Model No. 10848280 Artis Q ceiling- Model No. 10848281 Artis Q biplane- Model No. 10848282 Artis Q zeego- Model No. 10848283 Artis Q.zen floor- Model No. 10848353 Artis Q.zen ceiling- Model No. 10848354 Artis Q.zen biplane- Model No. 10848355

    FDA Enforcement
    Class II ·Ongoing·Siemens Medical Solutions USA, Inc·September 7, 2022

    System Material # Artis zee floor 10094135 Artis zee ceiling 10094137 Artis zee multi-purpose 10094139 Artis zee biplane 10094141 Artis zeego 10280959 Artis Q floor 10848280 Artis Q ceiling 10848281 Artis Q biplane 10848282 Artis Q.zeego 10848283 Artis Q.zen floor 10848353 Artis Q.zen ceiling 10848354 Artis Q.zen biplane 10848355 Fluoroscopic X-Ray System

    FDA Enforcement
    Class II ·Ongoing·Siemens Medical Solutions USA, Inc·February 8, 2023

    INLIVEN CRT-P, Model Numbers: a) V284 b) V285 c) W274 d) W275 (added 7/15/2021)

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·July 21, 2021