BEUDAMED
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    PIONEER MAXFUSE VERTEBRAL BODY REPLACEMENT DEVICE

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Novo Surgical

    FDA UDI
    NOVO SURGICAL, INC.·G586G1317240·wagner plastic surgery scissors, fine pattern, ...

    STRAUMANN TIBRUSH

    FDA 510(k)
    FDA Class 2 ·Dental

    SYNTHES SMALL COBINATION CLAMP-MR SAFE

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    SITTER SELECT

    FDA Adverse Event
    Malfunction ·J. T. POSEY CO.·Product code KMI·May 6, 2013

    COLLEAGUE PRE P1.7

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·June 16, 2011

    WINGSPAN STENT SYSTEM

    FDA Adverse Event
    Death ·NEUROVASCULAR DIVISION, BOSTON SCIENTIFIC CORP.·Product code NJE·August 21, 2008

    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

    Ultraview SL Command Modules, Model 91496, with the Masimo SpO2 PCBA, PN: 010-1636-02. The Spacelabs Multi-parameter Module is intended for use with the Patient Care Management System (PCMS) to acquire, monitor, and process various clinical parameters from an adult or neonate/infant populations in any type of clinical environment other than home use.

    FDA Enforcement
    Class II ·Terminated·Spacelabs Healthcare Inc·May 13, 2015