BEUDAMED
    13 results · 29ms · Sources: EU EUDAMED, US FDA

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    PRIMASOLO ONE-PIECE IMPLANTS & HEALING CAPS

    FDA 510(k)
    FDA Class 2 ·Dental

    Azur Pure Helical

    FDA UDI
    Microvention, Inc.·00810170018664·Azur

    InTess Lumbar Cage

    FDA UDI
    Kalitec Direct LLC·B07312K0105060·Inserter Sleeve, All Size Implants

    neoWave LS

    FDA UDI
    XENIX MEDICAL LLC·00818345024243·Lumbar Inserter, Inline- Lateral

    8050506

    FDA Adverse Event
    Malfunction ·November 8, 2018

    BIO-FASTAK SUTURE ANCHOR, MODEL AR-1324B

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    MICROSCAN SYNERGIES PLUS GRAM-NEGATIVE MIC/COMBO PANELS WITH CEFTRIAXONE (0.5-128 UG/ML)

    FDA 510(k)
    FDA Class 2 ·Microbiology

    9900

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·April 8, 2013

    TENDRIL ST

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

    HEARTSTART MRX - EMS DEFIBRILLATOR

    FDA Adverse Event
    Malfunction ·PHILIPS HEALTHCARE·Product code MKJ·April 5, 2011

    LifeShield Latex-Free Primary I.V. Set, Convertible Pin, 83 inch, with Backcheck Valve and 2 Clave Ports, Piggyback with Option-Lok; Made in Costa Rica, Hospira, Inc., Lake Forest, IL 60045 U.S.A.

    FDA Recall
    Terminated ·Hospira Inc.·Product code FPA·January 9, 2006

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

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

    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