BEUDAMED
    19 results · 26ms · Sources: EU EUDAMED, US FDA

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    APEX DAL ELECTRONIC APEX LOCATOR

    FDA 510(k)
    FDA Unclassified ·Unknown

    LEONE SPA

    FDA UDI
    LEONE SPA·08033707000952·MICRO SECT SCREWS U S/STEEL 6mm EXPANS.

    TiWAVE L Lumbar Cage System

    FDA UDI
    Kalitec Direct LLC·B07323K0101130·Distractor, Smooth Paddle, Lordotic, 13mm

    InTess Lumbar Cage

    FDA UDI
    Kalitec Direct LLC·B07312K0101130·Distractor, Smooth Paddle, 13mm

    General Instrument

    FDA UDI
    ALPHATEC SPINE, INC.·00840180506721·Longer Rotating Distractor, Holed, 13mm

    LASER MECHANISMS LASER SCANNING SYSTEM

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    PROVEN KNEE SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    HEDSTROEM FILE

    FDA Adverse Event
    Malfunction ·DENTSPLY TULSA DENTAL SPECIALTIES·Product code EKS·April 6, 2011

    RESERVOIR 3ML

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code FRN·April 26, 2013

    PINN MAR NEUT 36IDX58OD

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS, INC.·Product code LPH·July 18, 2008

    CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS

    FDA Adverse Event
    Injury ·COOK INC·Product code FOZ·August 22, 2022

    CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS

    FDA Adverse Event
    Injury ·COOK INC·Product code FOZ·August 22, 2022

    TRIPLE LUMEN POLYURETHANE CENTRAL VENOUS CATHETER SET

    FDA Adverse Event
    Malfunction ·COOK INC·Product code DQY·July 3, 2018

    TRIPLE LUMEN POLYURETHANE CENTRAL VENOUS CATHETER SET

    FDA Adverse Event
    Malfunction ·COOK INC·Product code DQY·July 3, 2018

    TRIPLE LUMEN POLYURETHANE CENTRAL VENOUS CATHETER SET

    FDA Adverse Event
    Malfunction ·COOK INC·Product code DQY·June 25, 2018

    Catheter, intravascular, therapeutic, short-term less than 30 days

    FDA Adverse Event
    Malfunction ·COOK INC·Product code FOZ·November 10, 2022

    1820334-2022-00399

    FDA Adverse Event
    Injury ·COOK INC·Product code LJS·March 16, 2022

    MINI INFANT < 3KG, RADIOTRANSLUCENT ELECTRODE, Physio-Control¿ Quik-Combo" Connector, REF/Catalog Number 2602M Indicated for use in external pacing, defibrillation and monitoring applications as a non-sterile, disposable device for single pediatric use, only. The PadPro 2602 electrodes provide the conductive interface between the defibrillator and/or the external transcutaneous (non-invasive) cardiac pacemaker and the pediatric patients skin. The electrode is intended for use on pediatric infants whose weight is less than 10 kg. (22 lbs.).

    FDA Enforcement
    Class II ·Terminated·ConMed Corporation·April 4, 2018

    On-Board Imager - Exact Arm Elbow Motor Shaft (kVD, kVS, and MV) with ''Type 01" elbow motors. Product Usage: The On-Board Imager device is an x-ray device used for evaluation of correct patient position in relation to isocenter and verification of treatment fields in relation to anatomical and fiducial landmarks.

    FDA Enforcement
    Class II ·Terminated·Varian Medical Systems, Inc.·April 30, 2014