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

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    NuVasive® Reline® System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    OSS™ Orthopedic Salvage System

    FDA UDI
    Biomet Orthopedics, LLC·00880304250796·

    TALOS®-C HA

    FDA UDI
    MEDITECH SPINE, LLC·B167521610140·

    Mui Scientific

    FDA UDI
    H & A Mui Enterprises Inc·10678467506112·Customized Single Use Antroduodenal 16 Channel ...

    Mui Scientific

    FDA UDI
    H & A Mui Enterprises Inc·10678467505467·16-Channel Customized Single-Use Colonic Catheter

    CARDINAL HEALTH

    FDA UDI
    Cardinal Health 200, LLC·10885425499076·WIRE CUTTER

    Symmetry Rochester-Pean

    FDA UDI
    ASPEN SURGICAL PRODUCTS, INC.·00887482040232·Symmetry® Forceps, Rochester-Pean Hemostatic, S...

    BOND BONE

    FDA 510(k)
    FDA Class 2 ·Dental

    ACTALYKE QC KIT, MODELS AQC-HP AND AQC-LP

    FDA 510(k)
    FDA Class 2 ·Hematology

    PRODIGY AUTOCODE

    FDA Adverse Event
    Injury ·OK BIOTECH CO., LTD.·Product code NBW·October 6, 2017

    CAPSUREFIX NOVUS

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

    OT VERIO IQ METER

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

    INFINITI VISION SYSTEM OZIL

    FDA Adverse Event
    Malfunction ·ALCON - IRVINE TECHNOLOGY CENTER·Product code HQC·June 17, 2011

    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

    NSK

    FDA Adverse Event
    Injury ·NAKANISHI INC.·Product code KMW·November 1, 2016

    OSS RS AXLE

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code KRO·August 3, 2023

    OSS POLY LOCK PIN

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code JDI·August 3, 2023

    OSS REINFORCED YOKE

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code KRO·August 3, 2023

    NSK

    FDA Adverse Event
    Malfunction ·NAKANISHI INC.·Product code EGS·November 1, 2016

    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