BEUDAMED
    11 results · 19ms · Sources: EU EUDAMED, US FDA

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    ORTHOPLUG HARD BONE DESIGN

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

    COMPRINET, COMTESSE AND BELLAVAR STOCKINGS

    FDA 510(k)
    FDA Class 2 ·General Hospital

    LPI ML 100/532 AND ML 532 SURGICAL LASER

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

    AMPLATZER SEPTAL OCCLUDER

    FDA Adverse Event
    Malfunction ·ABBOTT MEDICAL·Product code MLV·June 12, 2023

    PUMP IN STYLE ADVANCED BREAST PUMP GO TOTE

    FDA Adverse Event
    Malfunction ·MEDELA, INC.·Product code HGX·June 13, 2014

    FAST-FIX 360 STRAIGHT NDL DLVRY SYS

    FDA Adverse Event
    Malfunction ·SMITH & NEPHEW INC MANSFIELD MANUFACTURING SITE·Product code GAT·February 11, 2013

    QUICKFLEX MICRO LV LEAD

    FDA Adverse Event
    Injury ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code NIK·January 10, 2011

    TherMax Blood Warmer Unit-US, PrisMax Accessory, Product Codes: 955630, 955515, 955702, 955631

    FDA Recall
    Open, Classified ·VANTIVE US HEALTHCARE LLC·Product code KDI·July 28, 2025

    TherMax Blood Warmer Unit-US, PrisMax Accessory, Product Codes: 955630, 955515, 955702, 955631

    FDA Enforcement
    Class II ·Ongoing·VANTIVE US HEALTHCARE LLC·September 3, 2025

    Acumatch L-Series BIPOLAR LINER, 22mm (BIPOLAR ENDOPROSTHESIS-Hip), Item Numbers: a) 100-22-19, SZ. L; b) 100-22-20, SZ. M; c) 100-22-21, SZ. N; d) 100-22-22, SZ. P; e) 100-22-23, SZ. R; f) 100-22-24, SZ. S; g) 100-22-25, SZ. T

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·July 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