BEUDAMED
    15 results · 21ms · Sources: EU EUDAMED, US FDA

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    JGH1 Bone Graft Substitute

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    OSSURE LOEP KIT

    FDA Adverse Event
    Death ·AGNOVOS HEALTHCARE USA, LLC·Product code MQV·December 27, 2018

    OSSURE LOEP KIT

    FDA Adverse Event
    Death ·AGNOVOS HEALTHCARE USA, LLC·Product code MQV·January 18, 2020

    CoRoent

    FDA UDI
    Nuvasive, Inc.·00887517638908·CoRoent Ant TLIF PEEK, 8x11x34mm 12°

    HeartLight

    FDA UDI
    CARDIOFOCUS, INC.·00868976000130·Balloon Fill Media

    REPROCESSED EXTERNAL FIXATION ACCESSORIES

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    OSIRIX MD

    FDA 510(k)
    FDA Class 2 ·Radiology

    CARTIVA IMPLANT

    FDA Adverse Event
    Injury ·CARTIVA, INC·Product code PNW·November 13, 2020

    CARTIVA IMPLANT

    FDA Adverse Event
    Injury ·CARTIVA, INC·Product code PNW·November 9, 2020

    FLOGARD

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·October 17, 2014

    R3

    FDA Adverse Event
    Injury ·SMITH & NEPHEW ORTHOPAEDICS, LTD.·Product code NXT·June 21, 2013

    EON RECHARGEABLE IPG

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·July 21, 2011

    XIA TITANIUM 4.5 BLOCKER

    FDA Adverse Event
    Malfunction ·STRYKER SPINE-US·Product code NKB·September 3, 2020

    Reamer / Irrigator / Aspirator (RIA): RIA Drive Shafts, RIA Tube Assemblies, sterile, RIA Reamer Head, sterile (12.0mm-19.0mm); intended to clear the medullary canal of bone marrow and debris and to effectively size the medullary canal for the acceptance of an intramedullary implant or prosthesis

    FDA Enforcement
    Class II ·Terminated·Synthes, Inc.·July 22, 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