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

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    Ensite Velocity Cardiac Mapping System v5.0, Ensite Automap Module v1.0

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    AOS THREADED HALF PIN (AO STYLE) 5.0mm x 180mm x 70mm

    FDA UDI
    ADVANCED ORTHOPAEDIC SOLUTIONS, INC.·00848665016758·

    TOPSLANE DMLC

    FDA 510(k)
    FDA Class 2 ·Radiology

    EASYRA GLU-T REAGENT, EASYRA GLU-H REAGENT

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    T:SLIM G5 SYSTEM

    FDA Adverse Event
    Malfunction ·TANDEM DIABETES CARE·Product code OYC·December 3, 2021

    T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY

    FDA Adverse Event
    Malfunction ·TANDEM DIABETES CARE·Product code QFG·October 24, 2022

    INSERTION HANDLE FOR SUPRAPATELLAR

    FDA Adverse Event
    Malfunction ·WRIGHTS LANE SYNTHES USA PRODUCTS LLC·Product code JDS·February 10, 2020

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·June 23, 2025

    PUMP MMT-1715KM 630G 3ML BLACK MEDI  

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OZO·June 27, 2017

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·June 10, 2013

    MARQUIS SERIES STOPCOCK

    FDA Adverse Event
    Malfunction ·MERIT MEDICAL SYSTEMS, INC.·Product code DTL·June 2, 2011

    COLLEAGUE 3CX VOLUMETRIC INFUSION PUMP

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE PTE. LTD.·Product code FRN·September 16, 2008

    DRIVING CAP

    FDA Adverse Event
    Malfunction ·SYNTHES BETTLACH·Product code LXH·December 29, 2016

    INSERTION HANDLE FOR SUPRAPATELLAR

    FDA Adverse Event
    Malfunction ·WRIGHTS LANE SYNTHES USA PRODUCTS LLC·Product code JDS·August 16, 2021

    TFNA FEM NAIL Ø10 R 125° L320 TIMO15

    FDA Adverse Event
    Injury ·OBERDORF : SYNTHES PRODUKTIONS GMBH·Product code HSB·February 7, 2018

    10MM/125 DEG TI CANN TFNA 200MM - STERILE

    FDA Adverse Event
    Injury ·OBERDORF SYNTHES PRODUKTIONS GMBH·Product code HSB·February 21, 2018

    DRIVING CAP

    FDA Adverse Event
    Malfunction ·WRIGHTS LANE SYNTHES USA PRODUCTS LLC·Product code LXH·November 20, 2018

    8MM TI CANN TIBIAL NAIL-EX W/PROX BEND 300MM-STERILE

    FDA Adverse Event
    Malfunction ·SYNTHES SELZACH·Product code JDS·October 17, 2017

    Aespire View. This anesthesia gas machine is intended to provide general inhalation anesthesia and ventilatory support to patients and are to be used only by medical professionals trained and qualified in the administration of general anesthesia.

    FDA Enforcement
    Class I ·Ongoing·Datex-Ohmeda, Inc.·October 30, 2024