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

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    LIFESTYLE HOME TANNING UNITS

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

    Map-iT

    FDA UDI
    ACCESS POINT TECHNOLOGIES, INC.·00818087020404·STR, 10 electrode, MPD-DL, 5mm electrode spacing

    ALCODIGITAL BREATHALYZER, MODEL AT576, AT577, AT578, AT579

    FDA 510(k)
    FDA Class 1 ·Clinical Toxicology

    MERCURY MEDICAL HYPERINFLATION BAG SYSTEM, MODEL 83-900-0149

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    MAYFIELD ULTRA BASE UNIT

    FDA Adverse Event
    Malfunction ·INTEGRA LIFESCIENCES (LIMITED) LIMITED·Product code FWZ·May 5, 2014

    HOMECHOICE PRO

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - LARGO·Product code FKX·January 8, 2013

    ADAPTA DR

    FDA Adverse Event
    Death ·MEDTRONIC MED REL, INC.·Product code NVZ·November 17, 2010

    ALLURA Xper FD10; System Code: (1) 722003, (2)722010, (3)722026;

    FDA Enforcement
    Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·April 8, 2026

    The UniCel DxI 600 and 800 Access Immunoassay Systems, that are connected to an automation line. UniCel DxI 600 Catalog Numbers: A30260, A71460, A71461, A92060. Unicel DxI 800 Catalog Numbers: 973100, A71456, A71457, A84545, A25288, A25285.

    FDA Enforcement
    Class II ·Ongoing·Beckman Coulter Inc.·April 10, 2019

    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