BEUDAMED
    12 results · 19ms · Sources: EU EUDAMED, US FDA

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    OSCOR MEDICAL FIX SCREW PAC LEAD/PEEL CATH, MODIF

    FDA 510(k)
    FDA Class 3 ·Cardiovascular

    B.braun

    FDA UDI
    GRI Medical & Electronic Technology Co., Ltd.·16931918136394·Towel clamp_Non-sterile_1000ea/cs

    REVELATION DIAMOND

    FDA UDI
    Ss White Burs, Inc.·D6909132052·REVELATION DIAMOND 859-010F - 5 PACK

    MSI Precision Specialty Instruments

    FDA UDI
    Med Saver, Inc.·00194613023874·Metzenbaum Scissors, Curved, Delicate/Slender B...

    Novo Surgical

    FDA UDI
    NOVO SURGICAL, INC.·G5869132050·osteotome caps, gas or steam permeable, latex-f...

    Gen. Acces/ Instr. Tip Guard

    FDA UDI
    KATENA PRODUCTS, INC.·00841668110843·TIP GUARDS VENTED ASSORTED PACK OF 100

    ARTISYN Y-SHAPED MESH

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    MILLAR PRESSURE CONTROL UNIT MODEL PCU-2000

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    FINELINE II

    FDA Adverse Event
    Injury ·CPI - DEL CARIBE·Product code NVN·January 14, 2013

    TRANSFER SET WITH BREAK-AWAY

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - MALTA·Product code FPA·December 2, 2010

    SPECTRUM INFUSION PUMP

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE CORPORATION·Product code FRN·January 14, 2014

    Assurity Model Numbers: PM1240, PM2240; Assurity + Model Number: PM2260; Accent Model Numbers: PM1210, PM2210, PM1222, PM2212; Accent MRI Model Numbers: PM1224, PM2218, PM2224 Implantation of a single-chamber pulse generator, dual-chamber pulse generator, or CRT-P is indicated in one or more of the following permanent conditions: Syncope, Presyncope, Fatigue, Disorientation, Or any combination of those symptoms. Implantation of a CRT-P is indicated for: Maintaining synchrony of the left and right ventricles in patients who have undergone an AV nodal ablation for chronic atrial fibrillation and have NYHA Class II or III heart failure. The reduction of the symptoms of moderate to severe heart failure (NYHA Class III or IV) in those patients who remain symptomatic despite stable, optimal medical therapy, and have a left ventricular ejection fraction d35% and a prolonged QRS duration

    FDA Enforcement
    Class II ·Terminated·St Jude Medical Inc.·October 25, 2017