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

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    REMOTE PRESENCE SYSTEM, MODEL RP-VITA

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    UniTip High Resolution Catheter

    FDA UDI
    Unisensor AG·07640172970584·

    UniTip High Resolution Catheter

    FDA UDI
    Unisensor AG·07640172970591·

    S.O.F.T. PADDLE (SPECIAL OPTIMIZED FULL COMPRESSION TRAY), MODEL SFT-PDLE

    FDA 510(k)
    FDA Class 2 ·Radiology

    VENTRIO LIGHT HERNIA PATCH WITH TRM ANTIMICROBIAL COATING

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

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·May 21, 2013

    INTERMATE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - IRVINE·Product code FRN·September 26, 2014

    ACCU-CHEK ® MULTICLIX

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code FMK·June 14, 2011

    ARTIS Q ZEEGO

    FDA Adverse Event
    Malfunction ·SIEMENS HEALTHINEERS AG·Product code OWB·December 10, 2024

    ALARIS ETCO2

    FDA Adverse Event
    Malfunction ·CAREFUSION SD·Product code CCK·January 15, 2021

    ALARIS ETCO2

    FDA Adverse Event
    Malfunction ·CAREFUSION SD·Product code CCK·April 26, 2021

    Artis Q.zen Biplane, Model No. 10848355 Artis Q.zen Ceiling, Model No. 10848354 Artis Q.zen Floor, Model No. 10848353 Product Usage: Artis is a family of dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients.

    FDA Enforcement
    Class II ·Terminated·Siemens Medical Solutions USA, Inc·March 25, 2020

    Artis Q.zen biplane, Model Number 10848355

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

    Alaris PC units, Model No. 8015. Infusion pump.

    FDA Recall
    Terminated ·CareFusion 303, Inc.·Product code FRN·March 12, 2015

    Alaris PC unit model 8015 with software version 9.12 Product Usage: The Alaris PC unit is the central programming, monitoring and power supply component for the Alaris System.

    FDA Recall
    Terminated ·Carefusion Corporation·Product code FRN·March 6, 2013

    SmartSite Low Sorbing Infusion Set, Model No. 10015862 The SmartSite Infusion Sets are used to administer fluid and medications through a needle or catheter inserted into the patient's artery or vein. The set is comprised of components commonly found on intravascular administration sets and extension sets. It includes a SmartSite bag access port, a non-vented drip chamber, roller clamp, infusion pump segment, a male luer, and low sorbing tubing.

    FDA Recall
    Terminated ·CareFusion 303, Inc.·Product code FPA·January 13, 2015

    SmartSite Extension Set, Model No. 20029E. Used to administer fluid and medications through a needle or catheter inserted into the patient's artery or vein.

    FDA Recall
    Terminated ·CareFusion 303, Inc.·Product code FPA·October 9, 2015

    Alaris PC Unit, Model 8015

    FDA Recall
    Terminated ·CareFusion 303, Inc.·Product code FRN·June 12, 2017

    Alaris EtCO2 Module, Model 8300. A capnograph that continuously monitors end tidal carbon dioxide (EtCO2), fractional inspired carbon dioxide (FiCO2), and respiratory rate (RR).

    FDA Recall
    Terminated ·CareFusion 303, Inc.·Product code CCK·November 12, 2015

    CareFusion SmartSite Gravity Blood Set Model 42082E. Used to administer blood and blood products through a needle or catheter inserted into the patient's artery or vein.

    FDA Recall
    Terminated ·Carefusion 303 Inc 3750 Torrey View Ct San Diego CA 92130-2622·Product code FPA·December 20, 2012