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

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    X-ray Imaging System for the McLaren Proton Treatment System

    FDA 510(k)
    FDA Class 2 ·Radiology

    Integra® Miltex®

    FDA UDI
    INTEGRA LIFESCIENCES PRODUCTION CORPORATION·10381780362135·Integra® Miltex® Enucleation Scissors, 4-7/8", ...

    TENSO-COMFORT BLOOD PRESSURE METER, MODELS BPM 105 AND BPM 205

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    FATHOM (TM) 14 STEERABLE GUIDEWIRE

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    EMAX 2 PLUS MOTOR

    FDA Adverse Event
    Malfunction ·DEPUY SYNTHES POWER TOOLS·Product code HBC·June 21, 2013

    9800

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·July 7, 2011

    530G INSULIN PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OZO·October 17, 2014

    COOK COPE-LOOP CATHETER

    FDA Adverse Event
    Injury ·COOK INC·Product code LJE·August 23, 2021

    ULTRATHANE SUPRAPUBIC CATHETER SET

    FDA Adverse Event
    Malfunction ·COOK INC·Product code KOB·August 23, 2022

    COOK COPE-LOOP CATHETER

    FDA Adverse Event
    Injury ·COOK INC·Product code LJE·March 17, 2022

    COOK COPE-LOOP CATHETER

    FDA Adverse Event
    Injury ·COOK INC·Product code LJE·March 17, 2022

    COOK COPE-LOOP CATHETER

    FDA Adverse Event
    Injury ·COOK INC·Product code LJE·March 17, 2022

    COOK COPE-LOOP CATHETER

    FDA Adverse Event
    Injury ·COOK INC·Product code LJE·March 17, 2022

    COOK COPE-LOOP CATHETER

    FDA Adverse Event
    Injury ·COOK INC·Product code LJE·August 23, 2021

    COOK COPE-LOOP CATHETER

    FDA Adverse Event
    Injury ·COOK INC·Product code LJE·July 21, 2021

    NEUWAVE LK PROBE 15CM 17GA

    FDA Adverse Event
    Injury ·NEUWAVE MEDICAL, INC.·Product code NEY·March 22, 2019

    Boston Scientific Fetch 2 Aspiration Catheter, Catalog No. 109400-001. Product The Fetch 2 Aspiration Catheter is indicated for the removal of fresh, soft emboli and thrombi from vessels in the peripheral and coronary vasculature.

    FDA Enforcement
    Class I ·Terminated·Boston Scientific Corporation·April 27, 2016

    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