BEUDAMED
    17 results · 25ms · Sources: EU EUDAMED, US FDA

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    OSSEUS BLACK DIAMOND PEDICLE SCREW SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Meridian

    FDA UDI
    Seaspine Orthopedics Corporation·10889981265878·Trial, 39mm x 30mm x 18mm, 10 Deg

    Meridian

    FDA UDI
    Seaspine Orthopedics Corporation·10889981246624·Interbody, 39mm x 30mm X 18mm, 10 Deg

    DVR® CROSSLOCKEXTRA NARROW PLATE RIGHT (HEAD WIDTH X OVERALL LENGTH)

    FDA UDI
    Biomet Orthopedics, LLC·00880304811843·

    DVR® CROSSLOCK

    FDA UDI
    Biomet Orthopedics, LLC·00887868446115·

    AMPLATZER VASCULAR PLUG

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    3DHJD CAMERA SYSTEM MODEL

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

    GMK-PRIMARY FEMUR PS CEMENTED SIZE 6 L

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·July 16, 2020

    GMK-PRIMARY FEMUR PS CEMENTED SIZE 4

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·May 22, 2019

    GMK-PRIMARY FEMUR PS CEMENTED SIZE 4 LEFT

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·August 23, 2017

    GMK-PRIMARY FEMUR PS CEMENTED SIZE 6 L

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·September 25, 2018

    840 VENTILATOR

    FDA Adverse Event
    Injury ·COVIDIEN·Product code CBK·October 1, 2014

    OT VERIO IQ METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·May 29, 2013

    CAPSUREFIX NOVUS

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO, INC.·Product code DTB·June 16, 2011

    GMK-PRIMARY TIBIAL INSERT FIXED SIZE 2 / 14 MM

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·March 27, 2019

    INTELLIS

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code LGW·December 11, 2025

    Assurity Model Numbers: PM1240, PM2240; Assurity + Model Number: PM2260; Accent Model Numbers: PM1210, PM2210, PM1222, PM2212; Accent MRI Model Numbers: PM1224, PM2218, PM2224 Implantation of a single-chamber pulse generator, dual-chamber pulse generator, or CRT-P is indicated in one or more of the following permanent conditions: Syncope, Presyncope, Fatigue, Disorientation, Or any combination of those symptoms. Implantation of a CRT-P is indicated for: Maintaining synchrony of the left and right ventricles in patients who have undergone an AV nodal ablation for chronic atrial fibrillation and have NYHA Class II or III heart failure. The reduction of the symptoms of moderate to severe heart failure (NYHA Class III or IV) in those patients who remain symptomatic despite stable, optimal medical therapy, and have a left ventricular ejection fraction d35% and a prolonged QRS duration

    FDA Enforcement
    Class II ·Terminated·St Jude Medical Inc.·October 25, 2017