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

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    Foresight Intracardiac Echocardiography (ICE) System

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    TALOS® IBF

    FDA UDI
    MEDITECH SPINE, LLC·B16711511260·

    AGC TRADITION KNEE SYSTEM

    FDA UDI
    Biomet Orthopedics, LLC·00880304241183·

    Yellowstone

    FDA UDI
    SUMMIT SPINE LLC·B587P1511260·15mm PLIF Implant 11mm Wide 26mm Length

    Ardis®

    FDA UDI
    ZIMMER SPINE, INC.·00889024333994·

    ProLift Expandable Spacer System

    FDA UDI
    Life Spine, Inc.·00190837065683·

    Ardis®

    FDA UDI
    ZIMMER SPINE, INC.·00889024334724·

    TM Ardis Interbody System

    FDA UDI
    Highridge Medical, LLC·03662663193054·Trial

    Yellowstone

    FDA UDI
    SUMMIT SPINE LLC·B587P15112670·15mm PLIF Implant 11mm Wide 26mm Length 7 Degrees

    CARDIOSCOPE SONOPLUS 3000

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    PONTIS SUTURES AND SUTURE ANCHORS WITH OPTIONAL CRIMPS

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Hemodynamic monitoring system (HMS), comprised of a Patient Interface Module (Part Number 58401-000 and a User Interface Module (Part Number 58403-000). Intended for patients for whom the monitoring of continuous cardiac output is indicated for diagnostic and prognostic evaluation by a clinician in the hospital.

    FDA Enforcement
    Class II ·Terminated·ICU Medical, Inc.·May 16, 2018

    OT ULTRALINK METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·June 6, 2013

    GREENLIGHT ADDSTAT

    FDA Adverse Event
    Malfunction ·AMS, INNOVATION CENTER-SILICON VALLEY·Product code GEX·June 21, 2011

    GE OEC 9800

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS INC.·Product code JAA·September 9, 2008

    AERO LL FIXATION ANCHOR, 50MM

    FDA Adverse Event
    Malfunction ·STRYKER SPINE-US·Product code OVD·March 25, 2019

    OT VERIO2 METER

    FDA Adverse Event
    Injury ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·November 4, 2015

    Aquapak 640 SW, 650, mL w/040 Adaptor, International, Teleflex Medical, respiratory gas humidifier adaptor .

    FDA Enforcement
    Class II ·Terminated·Teleflex Medical·July 16, 2014

    ELEKTA LIMITED Precise Digital Accelerator, REF MRT 6001, MRT 6011; Medical Charged-Particle Radiation Therapy System Accelerator, Linear

    FDA Enforcement
    Class II ·Ongoing·Elekta, Inc.·December 13, 2023

    Medical Linear Accelerator

    FDA Enforcement
    Class II ·Terminated·Elekta, Inc.·September 14, 2016