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

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    RayStation 12A

    FDA 510(k)
    FDA Class 2 ·Radiology

    Philips

    FDA UDI
    Sbo Hearing A/S·05714464010950·HEARLINK 9030 MNR T R BE

    APEX PS Knee

    FDA UDI
    Omni Life Science, Inc.·00841690113584·PS-C Insert, Size 3 x 12mm

    Ophthalmic Knife

    FDA UDI
    KATENA PRODUCTS, INC.·00841668113295·STAB KNIFE 30 DEGREE (BX/5)

    ZAVATION CONNECTOR

    FDA UDI
    Zavation LLC·00197157021115·Open-Open/Large-Small 12mm Offset Connector

    PICCOLO PHOSPHORUS TEST SYSTEM

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    RA-T59 Wrist blood pressure monitor

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Ambassador Cervical Plate System

    FDA UDI
    Choice Spine, LP·00840996161237·AMBASSADOR,DRILL,2.3x12

    CURETTE

    FDA Adverse Event
    Malfunction ·MEDTRONIC SPINE LLC.·Product code LXH·August 24, 2011

    TOTAL ASR FEM IMP SIZE 47

    FDA Adverse Event
    Injury ·DEPUY INTERNATIONAL LTD. 8010379·Product code KXA·November 4, 2014

    ION PACLITAXEL-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC - GALWAY·Product code NIQ·July 12, 2013

    ARGENT SURGICAL SYSTEMS***BIOPSY Punches*** Disposable manual instrument for skin biopsy.

    FDA Enforcement
    Class II ·Terminated·Clorox Healthcare Holdings, LLC (dba HealthLink)·July 10, 2013

    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