BEUDAMED
    9 results · 18ms · Sources: EU EUDAMED, US FDA

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    QUANTIMETRIX TOTAL CREATINE KINASE CONTROL

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    Ophthalmic Cannula

    FDA UDI
    KATENA PRODUCTS, INC.·00841668109205·REV SIMCOE IRRIGATING-ASPIRATING CANNULA

    STAYFREE* DEODORANT MAXI-PADS

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    WAKO(TM) GOT II - HA

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code MDS·June 16, 2014

    HALO90 ABLATION CATHETER

    FDA Adverse Event
    Other ·BARRX MEDICAL INC.·Product code GEI·October 15, 2010

    IMMERSION HYDROBATH

    FDA Adverse Event
    Malfunction ·INVACARE TAYLOR STREET·Product code ILJ·December 14, 2012

    PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) NEONATAL TRACHEOSTOMY TUBE 2.5mm TTS FLEXTEND V FLANGE , Product Code/List Number/Item Code 67NFP25; b) NEONATAL TRACHEOSTOMY TUBE 3.0mm TTS FLEXTEND V FLANGE , Product Code/List Number/Item Code 67NFP30; c) NEONATAL TRACHEOSTOMY TUBE 3.5mm TTS FLEXTEND V FLANGE , Product Code/List Number/Item Code 67NFP35; d) NEONATAL TRACHEOSTOMY TUBE 4.0mm TTS FLEXTEND V FLANGE , Product Code/List Number/Item Code 67NFP40

    FDA Enforcement
    Class I ·Ongoing·Smiths Medical ASD Inc.·September 4, 2024

    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