BEUDAMED
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    VISION SYSTEM UPPER G.I. EXDOSCOPE

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    Synthes Patient Specific Implants

    FDA 510(k)
    FDA Class 2 ·Neurology

    Powder Free Vinyl Patient Examination Gloves, Clear (non-colored)

    FDA 510(k)
    FDA Class 1 ·General Hospital

    SM104 MSERIES W5TH WHLOBS3/07

    FDA Adverse Event
    Malfunction ·STRYKER MEDICAL-KALAMAZOO·Product code FPO·February 5, 2013

    PRECISION

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·December 21, 2010

    PYRAMID® ANTERIOR PLATE FIXATION SYSTEM

    FDA Adverse Event
    Injury ·MEDTRONIC SOFAMOR DANEK·Product code KWQ·July 18, 2014

    5.0MM TI SIDE-OPENING SCREW 40MM

    FDA Adverse Event
    Injury ·SYNTHES BRANDYWINE·Product code MNI·June 5, 2012

    5.0MM TI SIDE-OPENING SCREW 40MM

    FDA Adverse Event
    Injury ·SYNTHES BRANDYWINE·Product code MNI·June 5, 2012

    TI NUT 11MM WIDTH ACROSS FLATS

    FDA Adverse Event
    Injury ·SYNTHES BRANDYWINE·Product code MNI·June 5, 2012

    TI NUT 11MM WIDTH ACROSS FLATS

    FDA Adverse Event
    Injury ·SYNTHES BRANDYWINE·Product code MNI·June 5, 2012

    PKG, 5MM INSERT, MARYLAND DISSECTING FORCEPS, CURVED LEFT, 45CM, P/N 00250080578 Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and surgical auxiliaries such as suturing material. Some instruments have radio frequency (RF) ports which allow them to be used for electrosurgery. Laparoscopic surgical manual instruments are designed to be used endoscopically through cannulae to perform cutting, grasping, dissecting, retracting, and manipulating functions. This device does not sustain or support life.

    FDA Enforcement
    Class II ·Terminated·Stryker Endoscopy·December 24, 2014

    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