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

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    ALANINE AMINOTRANSFERASE (ALT)

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    LEONE SPA

    FDA UDI
    LEONE SPA·08033707035817·WEB I MOL BANDS G8421-16+G2820-00 LR 1

    DeRoyal

    FDA UDI
    DEROYAL INDUSTRIES, INC.·00749756654296·TOTAL KNEE TRAY

    LF

    FDA UDI
    Liebel-Flarsheim Company LLC·10746190005032·Illumena Neo Contrast Delivery System, Table Mo...

    DOUBLE ANTIBODY SERUM BENZODIAZEPINES

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    STUART TITANIUM SURGICAL MESH

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

    PYRAMESH® IMPLANT SYSTEM

    FDA Adverse Event
    Injury ·MEDTRONIC SOFAMOR DANEK·Product code EZX·July 17, 2014

    MultiDiagnost Eleva Part Numbers: 9896 001 41501 and 9896 001 41502

    FDA Recall
    Terminated ·Philips Medical Systems Sales & Service Region No. America·Product code IZI·June 8, 2004

    PLUM XLD LTN AMERICA

    FDA Adverse Event
    Malfunction ·HOSPIRA COSTA RICA LTD.·Product code FRN·May 15, 2014

    DURATA STS OPTIM ACTIVE FIXATION, DF-4 CONNECTOR

    FDA Adverse Event
    Injury ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code NVY·November 10, 2010

    TI MATRIX LOCKING CAP

    FDA Adverse Event
    Malfunction ·SYNTHES BRANDYWINE·Product code NKB·November 20, 2012

    PYRAMESH IMPLANT SYSTEM

    FDA Adverse Event
    Injury ·WARSAW ORTHOPEDICS·Product code EZX·December 9, 2016

    MultiDiagnost Eleva Flat Detector X-Ray System; Part Number: SW 9896 001 43361; Philips Medical Systems, Bothell, WA, 98021

    FDA Recall
    Terminated ·Philips Medical Systems North America Co. Phillips·Product code JAA·November 29, 2007

    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