BEUDAMED
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    LEADCARE BLOOD LEAD TESTING SYSTEM

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    Sklar

    FDA UDI
    SKLAR CORPORATION·10649111122408·NAIL/BONE RASP DE 7 INCHES 3-4MM

    M-ARS ACL: Anatomic Ribbon Surgery System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    VENTRICLEAR II, SPECTRUM VENTRICULAR DRAINAGE CATHETER, MODEL N-VVDC-02-ABRM

    FDA 510(k)
    FDA Class 2 ·Neurology

    ENDOPATH ENDOSCOPIC MULTIFEED STAPLER

    FDA Adverse Event
    Malfunction ·EES-JUAREZ·Product code GAG·April 15, 1997

    ENDOPATH ENDOSCOPIC MULTIFEED STAPLER

    FDA Adverse Event
    Malfunction ·EES-JUAREZ·Product code GAG·February 27, 1997

    SECURE II MED/SURG BED

    FDA Adverse Event
    Malfunction ·STRYKER MEDICAL-KALAMAZOO·Product code FNL·February 21, 2013

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    FDA Adverse Event
    Injury ·ANIMAS CORPORATION·Product code LZG·July 31, 2014

    TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC - MAPLE GROVE·Product code NIQ·January 27, 2011

    ENDOPATH ENDOSCOPIC MULTIFEED STAPLER

    FDA Adverse Event
    Malfunction ·ETHICON ENDO-SURGERY, INC.·Product code GAG·April 10, 1997

    ENDOPATH ENDOSCOPIC MULTIFEED STAPLER

    FDA Adverse Event
    Malfunction ·ETHICON ENDO-SURGERY, INC.·Product code GAG·April 10, 1997

    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