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

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    STAXX FX SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    LEONE SPA

    FDA UDI
    LEONE SPA·08033707060895·SOLDERABLE ROUND TUBE 36 - 6,5mm

    XANTALGIN CRONO

    FDA 510(k)
    FDA Class 2 ·Dental

    MODIFICATION TO S.M.A.R.T NITINOL STENT TRANSHEPATIC BILIARY SYSTEM

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

    METASUL DUROM, COMPONENT FOR ACETABULUM, UNCEMENTED, 48, 42,CODE H

    FDA Adverse Event
    Injury ·ZIMMER GMBH·Product code KWA·June 19, 2018

    TELIGEN

    FDA Adverse Event
    Malfunction ·GUIDANT CRM CLONMEL IRELAND·Product code LWS·April 11, 2013

    ALTRUA

    FDA Adverse Event
    Injury ·GUIDANT CRM CLONMEL IRELAND·Product code NVZ·April 13, 2011

    DURALOC CONST LINER 56/68X32

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS, INC.·Product code JDL·May 22, 2008

    SUBDURAL ELECTRODES, DEPTH ELECTRODES, AND ANCHOR BOLTS

    FDA Adverse Event
    Injury ·AD-TECH MEDICAL INSTRUMENT CORP.·Product code GZL·June 14, 2019

    METASUL DUROM, COMPONENT FOR ACETABULUM, UNCEMENTED, 54, 48, CODE N

    FDA Adverse Event
    Injury ·ZIMMER GMBH·Product code KWA·March 28, 2019

    METASUL DUROM, COMPONENT FOR ACETABULUM, UNCEMENTED, 50, 44, CODE J

    FDA Adverse Event
    Injury ·ZIMMER GMBH·Product code KWA·February 20, 2018

    METASUL DUROM, COMPONENT FOR ACETABULUM, UNCEMENTED, 50, 44, CODE J

    FDA Adverse Event
    Injury ·ZIMMER GMBH·Product code KWA·February 20, 2018

    METASUL DUROM, COMPONENT FOR ACETABULUM, UNCEMENTED, 46/ 40, CODE F

    FDA Adverse Event
    Injury ·ZIMMER GMBH·Product code KWA·June 13, 2018

    ULTRA FAST-FIX AB ASSEMBLY - CURVED-Absorbable Suture anchors Product Number: 72201494

    FDA Enforcement
    Class II ·Ongoing·Smith & Nephew, Inc.·October 28, 2020

    METASUL DUROM, COMPONENT FOR ACETABULUM, UNCEMENTED, 62/56, CODE V

    FDA Adverse Event
    Injury ·ZIMMER GMBH·Product code KWA·January 31, 2018

    CADD-Solis VIP ambulatory Infusion Pumps, Model 2110. Indicated for the following uses: Intra-arterial, subcutaneous, intraperitoneal, in close proximity to nerves, into an intraoperative site, epidural space or subarachnoid space. Therapies that require a continuous rate of infusion, intermittent bolus, and/or with patient-controlled demand doses.

    FDA Enforcement
    Class I ·Ongoing·Smiths Medical ASD Inc.·August 14, 2024

    Boston Scientific COGNIS CRT-D, Cardiac Resynchronization Therapy Defibrillator, models N118, N119. The following models are not available in the US: models N106, N107, P106, P107. Sterilized using ethylene oxide. Product Usage: Boston Scientific cardiac resynchronization therapy defibrillators (CRT-Ds) are indicated for patients with moderate to severe heart failure who remain symptomatic despite stable, optimal heart failure drug therapy and have left ventricular dysfunction and QRS duration > or equal to 120 ms. This family of pulse generators provide a variety of therapies including: -Ventricular tachyarrhythmia therapy, which is used to treat rhythms associated with sudden cardiac death such as VT and VF; -Cardiac Resynchronization Therapy (CRT), which treats heart failure by resynchronizing ventricular contractions through biventricular electrical stimulation; -Bradycardia pacing, including adaptive rate pacing, to detect and treat bradyarrhythmias and to provide cardiac rate support after defibrillation therapy.

    FDA Enforcement
    Class II ·Terminated·Boston Scientific CRM Corp·October 29, 2014