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

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    EVIS EXERA BRONCHOVIDEOSCOPE, OLYMPUS XBF-160Y3AC, XBF-1T160Y3AC,XBF-Q160Y2AC

    FDA 510(k)
    FDA Class 2 ·Ear, Nose, Throat

    APEX Knee System

    FDA UDI
    Omni Life Science, Inc.·00841690192541·Modular Knee Straight Reamer – Zimmer End, 22mm

    Marina Medical

    FDA UDI
    MARINA MEDICAL INSTRUMENTS, INC.·00840306810732·Joseph Nasal Scissors, Straight, 14cm

    TLS 5.0

    FDA UDI
    CAMBER SPINE TECHNOLOGIES, LLC·B0301000502200·Rotating Distractor, QC, IBFD, 7mm

    Mariner Outrigger

    FDA UDI
    Seaspine Orthopedics Corporation·10889981173005·L Con, Side-Loading, R, 8mm, 220mm

    XTRACTOR, MODEL M143

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

    MA-300 ELECTROMYOGRAPHY SYSTEM

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    Widex

    FDA UDI
    Widex A/S·05706069796902·Widex EVOKE E-IP (Light beige ) 220, Right

    Widex

    FDA UDI
    Widex A/S·05706069796926·Widex EVOKE E-IP (Dark brown ) 220, Right

    Widex

    FDA UDI
    Widex A/S·05706069796919·Widex EVOKE E-IP (Clay brown ) 220, Right

    EndoVive 3s Low Profile Balloon Kits Part Number: M00548830 (XMD P/N 70-0050-220) The EndoVive 3s Low Profile Balloon is intended to provide gastric access through a gastrointestinal stoma tract for enteral feeding, medication administration and gastric decompression. The EndoVive 3s Low Profile Balloon is indicated for use in adult and pediatric patients who require long-term feeding, are unable to tolerate oral feeding, are at low risk for aspiration or require gastric decompression and/or medication delivery directly into the stomach.

    FDA Enforcement
    Class II ·Terminated·Xeridiem Mediem Medical Devices Inc·March 2, 2016

    FREESTYLE FREEDOM

    FDA Adverse Event
    Malfunction ·Product code NBW·April 10, 2013

    VENTAK PRIZM

    FDA Adverse Event
    Injury ·GUIDANT CRM CLONMEL IRELAND·Product code LWS·April 12, 2011

    ENDEAVOR RX

    FDA Adverse Event
    Death ·MEDTRONIC CARDIOVASCULAR GALWAY·Product code NIQ·May 22, 2008

    IMPAX CV OUTBOUND (RESULTS MANAGEMENT 2.08)

    FDA Adverse Event
    Malfunction ·AGFA HEALTHCARE CORP·Product code LLZ·September 17, 2013

    SENSICA UO MONITOR ICU

    FDA Adverse Event
    Malfunction ·ADAPTEC MEDICAL DEVICES LLC 3014271001·Product code EXS·June 7, 2020

    M2A-MAGNUM PF CUP 58ODX52ID

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code KWA·November 28, 2017

    M2A-MAGNUM MOD HD SZ 52MM

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code KWA·November 28, 2017

    EndoVive 3s Low Profile Balloon Kits Part Number: M00548830 (XMD P/N 70-0050-220) The EndoVive 3s Low Profile Balloon is intended to provide gastric access through a gastrointestinal stoma tract for enteral feeding, medication administration and gastric decompression. The EndoVive 3s Low Profile Balloon is indicated for use in adult and pediatric patients who require long-term feeding, are unable to tolerate oral feeding, are at low risk for aspiration or require gastric decompression and/or medication delivery directly into the stomach.

    FDA Recall
    Terminated ·Xeridiem Mediem Medical Devices Inc·Product code PIF·December 23, 2015