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

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    CONQUEST SPINAL SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    BREATHING BAG

    FDA UDI
    King Systems Corporation·00612649185705·BAG,CUSTOM LATEX FREE

    LEONE SPA

    FDA UDI
    LEONE SPA·08033707065654·INTRAORAL ELASTICS 2,5 oz 1/4" red

    General Instrument

    FDA UDI
    ALPHATEC SPINE, INC.·00840180510124·Aspida Sacral Quad-Barrel Drill Guide

    MODIFICATION TO SYMPHONY GRAFT DELIVERY SYSTEM

    FDA 510(k)
    FDA Class 2 ·Dental

    SONOS AIRES 600 (SA-600)

    FDA 510(k)
    FDA Class 2 ·Radiology

    CD HORIZON SPINAL SYSTEM

    FDA Adverse Event
    Injury ·MEDTRONIC SOFAMOR DANEK USA, INC·Product code KWP·November 15, 2013

    CD HORIZON SPINAL SYSTEM

    FDA Adverse Event
    Injury ·MDT SOFAMOR DANEK USA, INC.·Product code KWP·October 30, 2019

    CD HORIZON SPINAL SYSTEM

    FDA Adverse Event
    Injury ·WARSAW ORTHOPEDICS·Product code KWP·June 26, 2020

    CD HORIZON® SPINAL SYSTEM

    FDA Adverse Event
    Injury ·WARSAW ORTHOPEDICS·Product code KWP·April 30, 2018

    CD HORIZON SPINAL SYSTEM

    FDA Adverse Event
    Injury ·WARSAW ORTHOPEDICS·Product code KWP·January 14, 2020

    CD HORIZON® SPINAL SYSTEM

    FDA Adverse Event
    Injury ·WARSAW ORTHOPEDICS·Product code KWP·April 30, 2018

    EDWARDS SAPIEN TRANSCATHETER HEART VALVE

    FDA Adverse Event
    Injury ·EDWARDS LIFESCIENCES·Product code NPT·May 2, 2013

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC MINIMED·Product code OYC·September 15, 2014

    HOMECHOICE LOW RECIRCULATION VOLUME APD SET WITH CASSETTE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·May 16, 2011

    CD HORIZON® SPINAL SYSTEM

    FDA Adverse Event
    Injury ·WARSAW ORTHOPEDICS·Product code KWP·May 8, 2017

    CD HORIZON SPINAL SYSTEM

    FDA Adverse Event
    Malfunction ·WARSAW ORTHOPEDICS·Product code KWP·February 2, 2021

    CD HORIZON® SPINAL SYSTEM

    FDA Adverse Event
    Injury ·WARSAW ORTHOPEDICS·Product code KWP·May 8, 2017

    Aurora 4 Series, Aurora 7 lighthead; Models: AUA7 (including TV models). The Aurora Series is intended to illuminate the surgical field and ensure visibility of the surgical site.

    FDA Enforcement
    Class II ·Ongoing·DKK Dai-Ichi Shomei Co., Ltd.·August 21, 2024