BEUDAMED
    13 results · 21ms · Sources: EU EUDAMED, US FDA

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    UreTron MultiProbe Lithotripter System

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    BLUE SKY BIO TCP

    FDA 510(k)
    FDA Class 2 ·Dental

    MICROPOWER HAND PIECE : MEDIUM SPEED DRILL, SAGGITAL SAW, RECIPROCATING SAW, AND OSCILLATING SAW

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY

    FDA Adverse Event
    Malfunction ·TANDEM DIABETES CARE·Product code QFG·October 16, 2023

    T:SLIM G5 SYSTEM

    FDA Adverse Event
    Malfunction ·TANDEM DIABETES CARE·Product code OYC·March 28, 2018

    T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY

    FDA Adverse Event
    Malfunction ·TANDEM DIABETES CARE·Product code QFG·December 20, 2022

    ONE TOUCH ULTRA

    FDA Adverse Event
    Malfunction ·LIFESCAN, INC.·Product code CFR·January 15, 2002

    HOMECHOICE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - LARGO·Product code FKX·June 10, 2013

    PRECISION XTRA

    FDA Adverse Event
    Malfunction ·Product code NBW·July 13, 2011

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC MINIMED·Product code OYC·September 19, 2014

    Simplexa HSV 1&2 Direct (MOL2150) with Direct Amplification Disc (MOL1451, MOL1452, MOL1455) Model Number: MOL2150, MOL1451, MOL1452, MOL1455

    FDA Enforcement
    Class I ·Terminated·Focus Diagnostics Inc·April 13, 2016

    Simplexa Flu A/B & RSV Direct (MOL2650) with Direct Amplification Disc (MOL1451, MOL1452, MOL1455) Model Number: MOL2650, MOL1451, MOL1452, MOL1455

    FDA Enforcement
    Class II ·Terminated·Focus Diagnostics Inc·April 13, 2016

    Simplexa Group A Strep Direct (MOL2850) with Direct Amplification Disc (MOL1451, MOL1452, MOL1455) Model Number: MOL2850, MOL1451, MOL1452, MOL1455

    FDA Enforcement
    Class I ·Terminated·Focus Diagnostics Inc·April 13, 2016