BEUDAMED
    23 results · 22ms · Sources: EU EUDAMED, US FDA

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    CDC Human Influenza Virus Real- time RT-PCR Diagnostic Panel, Influenza A/H5 Subtyping

    FDA 510(k)
    FDA Class 2 ·Microbiology

    Mixing Tips

    FDA UDI
    Gc America Inc.·D6581531481·Mixing Tips 48 x MIXING TIPS INJECTION NDS PINK

    Mixing Tips

    FDA UDI
    Gc America Inc.·10386040006187·Mixing Tips 48 x MIXING TIPS INJECTION NDS PINK

    CXR16

    FDA 510(k)
    FDA Class 2 ·Radiology

    AIDA DIAGNOSTIC ULTRASOUND SYSTEM

    FDA 510(k)
    FDA Class 2 ·Radiology

    ONE TOUCH ULTRA

    FDA Adverse Event
    Malfunction ·LIFESCAN, INC.·Product code CFR·March 21, 2002

    CLEARLINK PACLITAXEL SETS

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE CORPORATION·Product code FPA·February 2, 2024

    ASKU

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE CORPORATION·Product code FPA·January 6, 2026

    SEE H10

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE CORPORATION·Product code FPA·January 17, 2020

    ASKU

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE CORPORATION·Product code FPA·January 3, 2026

    ASKU

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE CORPORATION·Product code FPA·January 3, 2026

    DUO-VENT CLEARLINK LUER ACTIVATED VALVE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE CORPORATION·Product code FPA·July 12, 2023

    NI

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE CORPORATION·Product code FPA·May 23, 2017

    CONCERTO II CRT-D

    FDA Adverse Event
    Injury ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code NIK·June 8, 2013

    ALTRUA

    FDA Adverse Event
    Injury ·GUIDANT CRM CLONMEL IRELAND·Product code NVZ·July 7, 2011

    POLYFLUX S CAPILLARY DIALYZER

    FDA Adverse Event
    Malfunction ·GAMBRO DIAYLZATOREN GMBH·Product code KDI·September 4, 2008

    NI

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE CORPORATION·Product code FPA·May 23, 2017

    Artis zee biplane, Model Number 10094141

    FDA Enforcement
    Class II ·Terminated·Siemens Medical Solutions USA, Inc·July 31, 2019

    Artis zee biplane, Model Number 10094141

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

    Artis zee/ zeego systems; Product Usage: Usage: Artis zee/ zeego systems are dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients. Procedures that can be performed include cardiac angiography, neuro angiography, general angiography, rotational angiography, multipurpose angiography and whole body radiographic/fluoroscopic procedures. .

    FDA Enforcement
    Class II ·Terminated·Siemens Medical Solutions USA, Inc·July 1, 2015