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

    Get notified when this changes

    We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.
    Filters Regulation: Us FDA ×

    BeneVision Central Monitoring System

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    FULL AUTOMATIC (NIBP) BLOOD PRESSUE MONITOR

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    1.5T OPTIMA MR430S

    FDA 510(k)
    FDA Class 2 ·Radiology

    T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY

    FDA Adverse Event
    Malfunction ·TANDEM DIABETES CARE·Product code QFG·November 4, 2021

    CORIN OPTIMIZED POSITIONING SYSTEM

    FDA Adverse Event
    Malfunction ·OPTIMIZED ORTHO PTY LTD·Product code LZO·December 11, 2019

    CORIN OPTIMIZED POSITIONING SYSTEM

    FDA Adverse Event
    Injury ·OPTIMIZED ORTHO PTY LTD·Product code LZO·December 2, 2019

    CORIN OPTIMIZED POSITIONING SYSTEM

    FDA Adverse Event
    Malfunction ·OPTIMIZED ORTHO PTY LTD·Product code LZO·February 12, 2020

    CORIN OPTIMIZED POSITIONING SYSTEM

    FDA Adverse Event
    Malfunction ·OPTIMIZED ORTHO PTY LTD·Product code LZO·December 11, 2019

    CORIN OPTIMIZED POSITIONING SYSTEM

    FDA Adverse Event
    Malfunction ·OPTIMIZED ORTHO PTY LTD·Product code LZO·December 10, 2019

    CORIN OPTIMIZED POSITIONING SYSTEM

    FDA Adverse Event
    Injury ·OPTIMIZED ORTHO PTY LTD·Product code LZO·December 10, 2019

    CORIN OPTIMIZED POSITIONING SYSTEM

    FDA Adverse Event
    Injury ·OPTIMIZED ORTHO PTY LTD·Product code LZO·December 11, 2019

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC MINIMED·Product code OYC·October 17, 2014

    3.5MM CORTEX SCREW SELF-TAPPING 32MM

    FDA Adverse Event
    Malfunction ·SYNTHES (USA)·Product code HWC·June 21, 2013

    COLLEAGUE PRE P1.7

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·July 28, 2011

    CARTO 3 SYSTEM

    FDA Adverse Event
    Malfunction ·BIOSENSE WEBSTER INC·Product code DQK·December 14, 2023

    CORIN OPTIMIZED POSITIONING SYSTEM

    FDA Adverse Event
    Injury ·OPTIMIZED ORTHO PTY LTD·Product code LZO·December 10, 2019

    CORIN OPTIMIZED POSITIONING SYSTEM

    FDA Adverse Event
    Injury ·CORIN AUSTRALIA PTY LTD·Product code LZO·December 9, 2019

    CORIN OPTIMIZED POSITIONING SYSTEM

    FDA Adverse Event
    Malfunction ·OPTIMIZED ORTHO PTY LTD·Product code LZO·December 2, 2019

    bvi Beaver Safety Sideport Knife: (a) 1.0mm, 45o, REF 378210 (b) 1.2mm, 45o, REF 378212 (c) 115mm, 45o, REF 378231 Product Usage: Specialty blades and knives are used for stab and cut incisions in ophthalmic, ENT and other surgical applications.

    FDA Enforcement
    Class II ·Terminated·Beaver-Visitec International Inc.·February 7, 2018