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

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    GTS GREAT TOE SYSTEM - (METATARSAL COMPONENT WITH POROUS COATING)

    FDA 510(k)
    FDA Unclassified ·Unknown

    PICCOLO BASIC METABOLIC PANEL

    FDA Adverse Event
    Malfunction ·ABAXIS, INC.·Product code CGX·October 22, 2020

    PICCOLO COMPREHENSIVE METABOLIC PANEL

    FDA Adverse Event
    Malfunction ·ABAXIS, INC.·Product code CGX·November 3, 2020

    MatriDerm pluS+ Bi-Layer

    FDA 510(k)
    FDA Unclassified ·Unknown

    PARALLAX ACRYLIC RESIN WITH TRACERS TA

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    HOMECHOICE

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

    LIFESTYLE ULTRA THIN

    FDA Adverse Event
    Injury ·SURETEX LTD.·Product code HIS·December 10, 2010

    MINICAP TRANSFER SET

    FDA Adverse Event
    Death ·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code KDJ·July 22, 2014

    Exactech Equinoxe CAGE GLENOID, CEMENTED, alpha curvature, Mates with: a) 38, 41, 44 head, Small, Item Number 314-13-02, b) 38, 41, 44 head, Medium, Item Number 314-13-03, c) 38, 41, 44 head, Large, Item Number 314-13-04; Shoulder Arthroplasty

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·April 10, 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