BEUDAMED
    20 results · 23ms · Sources: EU EUDAMED, US FDA

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    Uroview FD

    FDA 510(k)
    FDA Class 2 ·Radiology

    OSS™ Orthopedic Salvage System

    FDA UDI
    Biomet Orthopedics, LLC·00880304250840·

    LEONE SPA

    FDA UDI
    LEONE SPA·08033707002970·BALL HOOKS 0,9mm

    Mui Scientific

    FDA UDI
    H & A Mui Enterprises Inc·10678467508239·Single Use Anorectal 16 Ch Catheter

    Mui Scientific

    FDA UDI
    H & A Mui Enterprises Inc·10678467505986·Customized Single-Use Esophageal 16ch Catheter

    CARDINAL HEALTH

    FDA UDI
    Cardinal Health 200, LLC·10885425499083·STRL FORCEP STAINLESS SPONGE

    Glidesheath Slender Hydrophilic Coated Introducer Sheath, 5FR - 10CM (0.021), REF/Product Code RM*RS5F10PA, STERILE, Rx ONLY

    FDA Enforcement
    Class II ·Terminated·Terumo Medical Corp·December 20, 2017

    Glidesheath Slender Hydrophilic Coated Introducer Sheath, 7FR - 16CM (0.021), REF/Product Code RM*RS7F16PA, STERILE, Rx ONLY

    FDA Enforcement
    Class II ·Terminated·Terumo Medical Corp·December 20, 2017

    PRODIGY AUTOCODE

    FDA Adverse Event
    Injury ·OK BIOTECH CO., LTD.·Product code NBW·June 29, 2017

    SURGIMAP (TM) SPINE

    FDA 510(k)
    FDA Class 2 ·Radiology

    TRIGEN META-NAIL RETROGRADE FEMORAL AND TIBIAL NAILS

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    BELLAFILL DERMAL FILLER

    FDA Adverse Event
    Injury ·SUNEVA MEDICAL, INC.·Product code LMH·January 6, 2017

    PRODIGY AUTOCODE

    FDA Adverse Event
    Injury ·OK BIOTECH CO., LTD.·Product code NBW·August 13, 2017

    G7 STR MONOBLOCK SHELL INSRTR

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code LXH·May 2, 2018

    CAPSUREFIX NOVUS

    FDA Adverse Event
    Injury ·MPRI·Product code DTB·October 10, 2014

    ACCESS 2 IMMUNOASSAY SYSTEM

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER, INC.·Product code JJE·June 17, 2011

    OT VERIO IQ METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·June 11, 2013

    AMT Bridle - Nasal Tube Retaining System Used with Nasogastric/Nasointestinal (NG/NI) tubes.

    FDA Enforcement
    Class III ·Terminated·Applied Medical Technology Inc·March 1, 2017

    Glidesheath Slender Hydrophilic Coated Introducer Sheath A-Kit, 6FR - 10CM (0.021), REF/Product Code RM*ES6F10HAU, STERILE, Rx ONLY

    FDA Enforcement
    Class II ·Terminated·Terumo Medical Corp·December 20, 2017

    CNSystems TASK FORCE MONITOR 3040i, plethysmograph, impedance. Noninvasively measure and display patient's hemodynamic parameters time synchronized using Impedance Cardiography (ICG), Electrocardiography (ECG), oscillometric Blood Pressure (oscBP) and continuous Blood Pressure (contBP). Furthermore Sympathic Tone and Parasympathic Tone are calculated by power spectral analysis of ECG (heart rate variability) and continuous blood pressure (blood pressure variability) as well as the Baroreceptor Reflex Sensitivity (BRRS). For use by medically trained personnel. It has been designed for diagnoses aiding and must not be used for vital sign monitoring of critically ill patients under absence of additional, suitable self-monitoring devices or medical trained personnel. The device measures continuously the subject's hemodynamic parameters without reporting any diagnosis. It is the physician's responsibility to make proper judgment based on these parameters.

    FDA Enforcement
    Class II ·Terminated·Partners In Medicine Llc·January 13, 2016