BEUDAMED
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    SURGIMED - SURGICAL BLADES

    FDA 510(k)
    FDA Class 1 ·General, Plastic Surgery

    NC Straumann Variobase Abutment for Bars/Bridges, RC Straumann Variobase Abutment for Bars/Bridges, NNC Straumann Variobase Abutment for Bars/Bridges, RN Straumann Variobase Abutment for Bars/Bridges, WN Straumann Variobase Abutment for Bars/Bridges

    FDA 510(k)
    FDA Class 2 ·Dental

    INSTRU-SAFE INSTRUMENT PROTECTION SYSTEMS

    FDA 510(k)
    FDA Class 2 ·General Hospital

    POWER PRO IT AMBULANCE - OBS

    FDA Adverse Event
    Injury ·STRYKER MEDICAL-KALAMAZOO·Product code FPO·June 5, 2014

    LCS COMPLETE M/B PAT CEM LG

    FDA Adverse Event
    Injury ·DEPUY IRELAND·Product code NJL·November 29, 2012

    NXSTAGE SYSTEM ONE

    FDA Adverse Event
    Injury ·NXSTAGE MEDICAL, INC.·Product code KDI·September 29, 2010

    Exactech Equinoxe CAGE GLENOID,POSTERIOR AUGMENT, CEMENTED, Left, Mates with: a) 38, 41, 44, 47 head, Small, Item Number 314-13-22, b) 41, 44, 47, 50, head, Medium, Item Number 314-13-23, c) 44, 47, 50, 53 head, Large, Item Number 314-13-24, d) 44, 47, 50, 53 head, Extra Large, Item Number 314-13-25; 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