BEUDAMED
    12 results · 27ms · Sources: EU EUDAMED, US FDA

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    Z-CHAIR

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    ELECSYS CA 15-3 CALCHECK

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    HNC-127 NEUROVASCULAR ARRAY COIL

    FDA 510(k)
    FDA Class 2 ·Radiology

    QUILL SRS

    FDA Adverse Event
    Malfunction ·SURGICAL SPECIALTIES CORP. (DBA ANGIOTECH)·Product code NEW·April 17, 2009

    QUILL SRS

    FDA Adverse Event
    Other ·SURGICAL SPECIALTIES CORPORATION (DBA ANGIOTECH)·Product code NEW·May 12, 2009

    QUILL SRS

    FDA Adverse Event
    Other ·SURGICAL SPECIALTIES CORP. (DBA ANGIOTECH)·Product code NEW·August 24, 2009

    EON MINI

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·April 4, 2013

    ESPRIT VENTILATOR

    FDA Adverse Event
    Malfunction ·RESPIRONICS CALIFORNIA, INC.·Product code CBK·April 12, 2011

    ACCU-CHEK AVIVA TEST STRIPS

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code LFR·May 6, 2008

    MOZAIK

    FDA Adverse Event
    Injury ·ISOTIS ORTHOBIOLOGICS INC.·Product code MQV·January 7, 2021

    Integra Mozaik Putty 2.5cc, 5 cc, 10 cc Product Usage: The product is a bone graft substitute composed of collagen (Type 1) and ceramic (IP3-Tricalcium phosphate) matrix in putty and strip forms. The product is intended for use as a bone void filler to fill voids or gaps of the skeletal system in the extremities, spine. and pelvis not intrinsic to the stability of the bony structure. Integra Mozaik is also indicated for use in the treatment of surgically treated osseous defects or osseous defects created from traumatic injury to the bone. Following placement in the bone void or a defect Integra Mozaik is reabsorbed and replaced with bone during the healing process.

    FDA Enforcement
    Class II ·Terminated·Integra LifeSciences Corp.·June 20, 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