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

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    Zenysis Short-Term Dialysis Catheter

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

    APEX Knee System

    FDA UDI
    Omni Life Science, Inc.·00841690197058·Revision Knee Spiral Reamer- Hudson Short Flute...

    Ophthalmic Speculum

    FDA UDI
    KATENA PRODUCTS, INC.·00841668100295·FRANKEL INFANT EYE SPECULUM

    Ophthalmic Speculum

    FDA UDI
    KATENA PRODUCTS, INC.·00841668100349·FEMTO SPECULUM FLAT WIRE

    T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY

    FDA Adverse Event
    Malfunction ·TANDEM DIABETES CARE·Product code QFG·June 28, 2023

    TRU LEGIONELLA

    FDA 510(k)
    FDA Class 2 ·Microbiology

    PROFIL COMPOSITES (PROFIL, PROFIL FLOW)

    FDA 510(k)
    FDA Class 2 ·Dental

    T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY

    FDA Adverse Event
    Malfunction ·TANDEM DIABETES CARE·Product code QFG·May 11, 2022

    OT VERIO IQ METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·October 16, 2013

    T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY

    FDA Adverse Event
    Malfunction ·TANDEM DIABETES CARE·Product code QFG·June 22, 2022

    SKYLINE SPRING CLIP DRIVER

    FDA Adverse Event
    Malfunction ·DEPUY SYNTHES SPINE·Product code HWR·June 8, 2013

    HIRES 90K

    FDA Adverse Event
    Malfunction ·ADVANCED BIONICS LLC·Product code MCM·September 4, 2008

    ZIMMER ARTICULAR SURFACE WITH HINGE POST

    FDA Adverse Event
    Injury ·ZIMMER, INC.·Product code KRO·June 23, 2011

    PREVENA PLUS INCISION MANAGEMENT SYSTEM

    FDA Adverse Event
    Injury ·KINETIC CONCEPTS, INC·Product code OMP·September 24, 2021

    PREVENA PLUS¿ INCISION MANAGEMENT SYSTEM

    FDA Adverse Event
    Injury ·KINETIC CONCEPTS, INC.·Product code OMP·July 19, 2019

    Integrity 1.1. Integrity is the interface and control software for the Elekta range of medical digital linear accelerators and is intended to assist a licensed practitioner in the delivery of radiation to defined target volumes.

    FDA Enforcement
    Class II ·Terminated·Elekta, Inc.·April 9, 2014

    Artis zee/ zeego systems; 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·August 26, 2015

    The Artis zee / zeego Angiography System is designed as a set of components that may be combined into different configurations to provide specialized angiography systems.

    FDA Enforcement
    Class II ·Terminated·Siemens Medical Solutions USA, Inc·December 10, 2014

    Siemens Artis zee systems; dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients. Procedures that can be performed include cardiac angiography, neuro angiography, general angiography, rotational angiography, multipurpose angiography and whole body radiographic/fluoroscopic procedures.

    FDA Enforcement
    Class II ·Terminated·Siemens Medical Solutions USA, Inc·August 12, 2015