BEUDAMED
    12 results · 23ms · Sources: EU EUDAMED, US FDA

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    GYRUS PLASMACISION AND PLASMABLEND ELECTRODES

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

    Marina Medical

    FDA UDI
    MARINA MEDICAL INSTRUMENTS, INC.·00840306813214·Fomon Dorsal Scissors, Angled, 14cm

    Mariner Outrigger

    FDA UDI
    Seaspine Orthopedics Corporation·10889981173128·L Con, Side-Loading, R, 8mm, 460mm

    2.0 LACTOSORB SYSTEM STRAIGHT PLATE 4 HOLE

    FDA Adverse Event
    Injury ·BIOMET MICROFIXATION·Product code HRS·December 27, 2019

    URINE AMPHETAMINE/METHAMPHETAMINE (AMPH) SCREEN FLEX REAGENT, CATALOG NO. DF 90A

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    LIFELINES TRACKIT

    FDA 510(k)
    FDA Class 2 ·Neurology

    DEPUY ASR XL FEM IMP SIZE 45

    FDA Adverse Event
    Injury ·DEPUY INTERNATIONAL·Product code KWA·April 10, 2013

    TENDRIL SDX

    FDA Adverse Event
    Injury ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code DTB·May 27, 2008

    TRANSVENOUS

    FDA Adverse Event
    Injury ·CPI - DEL CARIBE·Product code NVN·April 12, 2011

    Belmont Rapid Infuser, a Fluid Management System, Model FMS2000.

    FDA Enforcement
    Class II ·Terminated·Belmont Instrument Corporation·October 24, 2012

    Alaris Syringe Pump, Model No. 8110. Delivers fluids. Expansion of Affected Units: BOM Housing Assembly Service, Part No. 49000226, and Lower Housing/Carriage Block Assembly, Part No. 148188-100.

    FDA Enforcement
    Class I ·Terminated·CareFusion 303, Inc.·August 26, 2015

    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