BEUDAMED
    9 results · 26ms · Sources: EU EUDAMED, US FDA

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    DIGITRACE SLEEP COMPUTER, SLEEPPAC, HOME SLEEP SYSTEM

    FDA 510(k)
    FDA Class 2 ·Neurology

    IMMULITE DIGOXIN

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    ACCESS(R) TOTAL T3

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    RESERVOIR 3ML

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code FRN·February 5, 2013

    STERLING BALLOON DILATATION CATHETER

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC - MAPLE GROVE·Product code DQY·January 3, 2011

    SYSTEM, PERITONEAL, AUTOMATIC DELIVERY

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE CORPORATION·Product code FKX·July 18, 2014

    smiths medical ProPort Plastic Venous Access System, PolyFlow Polyurethane Catheter, 2.6mm O.D. (7.8Fr) x 1.6mm I.D., REF 21-4155-24

    FDA Enforcement
    Class I ·Ongoing·Smiths Medical ASD, Inc.·March 26, 2025

    PKG, DOLPHIN FORCEPS, SERRATED SPOON, P/N 0250080280. Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and surgical auxiliaries such as suturing material. Some instruments have radio frequency (RF) ports which allow them to be used for electrosurgery. Laparoscopic surgical manual instruments are designed to be used endoscopically through cannulae to perform cutting, grasping, dissecting, retracting, and manipulating functions. This device does not sustain or support life.

    FDA Enforcement
    Class II ·Terminated·Stryker Endoscopy·December 24, 2014

    Anthem Model Numbers: PM3210, PM3212; Allure/Relieve Model Numbers: PM3222, PM3242, PM3262, PM3542, PM3224, PM3244 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