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

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    ULTRASONIC NEBULIZER

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    CHS

    FDA UDI
    Smith & Nephew, Inc.·03596010062277·AMBI COMPRESSION HIP SCREW PLATE 10SL 220MM 150D

    UniTip High Resolution Catheter

    FDA UDI
    Unisensor AG·07640172974032·UniTip High Resolution Catheter 12F

    GOLDWAY PATIENT MONITOR, MODEL # UT4000F

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    CENTROX, RELIANT, ULTROX, AS-D+, AS-E, AS-G, AS-J, AS-K AND AS-L

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    RESTORE ULTRA

    FDA Adverse Event
    Malfunction ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·December 9, 2011

    ANGEL SYSTEM WITH ASPIRATION KIT W/ ACDA

    FDA Adverse Event
    Injury ·ARTHREX, INC.·Product code ORG·March 5, 2019

    RESTORE ULTRA

    FDA Adverse Event
    Injury ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·November 5, 2015

    ARTHREX ANGEL SYSTEM WITH ASPIRATION KIT

    FDA Adverse Event
    Injury ·ARTHREX, INC.·Product code ORG·May 1, 2019

    HOMECHOICE LOW RECIRCULATION VOLUME APD SET WITH CASSETTE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·June 13, 2011

    CONFIRM

    FDA Adverse Event
    Malfunction ·ST. JUDE MEDICAL, INC., CRMD·Product code MXC·January 13, 2014

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·May 20, 2013

    MPACT TWO HOLES CEMENTLESS ACETABULAR CUP

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL, SA·Product code LPH·July 29, 2014

    RELION SK

    FDA Adverse Event
    Malfunction ·TRIVIDIA HEALTH, INC.·Product code NBW·August 2, 2017

    ALINITY C PROCESSING MODULE

    FDA Adverse Event
    Malfunction ·ABBOTT GMBH·Product code JJE·March 17, 2021

    MPACT ACETABULAR SHELL Ø54 TWO-HOLES

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code LPH·December 16, 2016

    ACETLR CUP HAP 60MM W/ IMPTR

    FDA Adverse Event
    Injury ·SMITH & NEPHEW ORTHOPAEDICS LTD·Product code NXT·November 15, 2020

    Siemens Artis Q biplane---Interventional Fluoroscopic X-Ray System Model Number: 10848282

    FDA Enforcement
    Class II ·Terminated·Siemens Medical Solutions USA, Inc·July 10, 2019

    Artis Q Biplane, Model No. 10848282; Artis Q Ceiling, Model No.10848281; Artis Q Floor, Model No. 10848280; Artis Q zeego, Model No. 10848283 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 biplane, Model Number 10848282

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