BEUDAMED
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    PROCEM

    FDA 510(k)
    FDA Class 2 ·Dental

    Polystar HK

    FDA UDI
    Merz Dental GmbH·D7091984248·anteriors; shade B1; mould Q 83

    DPC T60I KUSTI, MODEL 984248; DPC T60I, MODEL 984247

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    CONVERTER SYSTEM

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    MODIFIED DDI SEROCARD CMV IGG TEST KIT

    FDA 510(k)
    FDA Class 2 ·Microbiology

    RIATA ST ACTIVE FIXATION

    FDA Adverse Event
    Malfunction ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code NVY·February 28, 2013

    ICL (IMPLANTABLE COLLAMER LENS)

    FDA Adverse Event
    Injury ·STAAR SURGICAL COMPANY·Product code HQL·February 10, 2011

    EDWARDS SAPIEN XT TRANSCATHETER HEART VALVE, 23MM

    FDA Adverse Event
    Death ·EDWARDS LIFESCIENCES·Product code NPT·August 6, 2014

    Exactech Equinoxe GLENOID, POSTERIOR AUGMENT,PEGGED, CEMENTED, 8o, LEFT, Mates with: a) 38, 41, 44, 47 head, Small, Item Number 314-02-22, b) 41, 44, 47, 50 head, Medium, Item Number 314-02-23, c) 44, 47, 50, 53 head, Large, Item Number 314-02-24, d) 44, 47, 50, 53 head, Extra Large, Item Number 314-02-25; Shoulder Arthroplasty

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·April 10, 2024

    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