BEUDAMED
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    PROCERA BRIDGE ZIRCONIA

    FDA 510(k)
    FDA Class 2 ·Dental

    LIFEMATE HEMOFILTRATION SYSTEM

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

    MONOJECT PREFILL 0.9% SODIUM CHLORIDE FLUSH SYRINGE

    FDA 510(k)
    FDA Class 2 ·General Hospital

    TSRH® SPINAL SYSTEM

    FDA Adverse Event
    Malfunction ·MEDTRONIC SOFAMOR DANEK·Product code KWP·April 19, 2013

    TSRH SPINAL SYSTEM

    FDA Adverse Event
    Malfunction ·MEDTRONIC ORTHOPEDIC INC.·Product code KWP·December 4, 2009

    LINEAR 7.5 FR. 25CC IAB

    FDA Adverse Event
    Malfunction ·DATASCOPE CORP. - FAIRFIELD·Product code DSP·October 17, 2019

    LINEAR 7.5 FR. 25CC IAB

    FDA Adverse Event
    Malfunction ·DATASCOPE CORP. - FAIRFIELD·Product code DSP·October 17, 2019

    TSRH SPINAL SYSTEM

    FDA Adverse Event
    Malfunction ·WARSAW ORTHOPEDIC INC.·Product code KWP·December 4, 2009

    TSRH SPINAL SYSTEM

    FDA Adverse Event
    Malfunction ·WARSAW ORTHOPEDICS·Product code KWP·May 29, 2013

    ENDOTAK RELIANCE

    FDA Adverse Event
    Malfunction ·CPI - DEL CARIBE·Product code NVY·April 8, 2013

    NCB FULLY THREAD.CANCEL.SCREW

    FDA Adverse Event
    Injury ·ZIMMER GMBH·Product code HRS·March 25, 2011

    BIPOLAR LEAD MODEL

    FDA Adverse Event
    Malfunction ·CYBERONICS, INC.·Product code LYJ·May 9, 2008

    TSRH SPINAL SYSTEM

    FDA Adverse Event
    WARSAW ORTHOPEDIC, INC.·Product code KWP·August 26, 2011

    LINEAR 7.5 FR. 40CC IAB

    FDA Adverse Event
    Injury ·DATASCOPE CORP. - FAIRFIELD·Product code DSP·May 14, 2020

    PKG, 5MM X 45CM, INSERT, METZENBAUM CURVED SCISSORS, LONG JAW, P/N 0250080752 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

    Medfusion Syringe Pump, Model 4000. The Model 4000 pump is a small, lightweight and portable syringe infusion pump. The pump offers a variety of delivery modes programmable to meet specific patient care needs.

    FDA Enforcement
    Class I ·Terminated·Smiths Medical ASD Inc.·December 18, 2019

    Marathon Flow Directed Micro Catheter, UltraFlow HPC Flow Directed Micro Catheter Marathon Flow: The device is intended to access periphera and neurovasculature for the controlled selective infusion of physician-specified therapeutics agents such as embolization materials and of diagnostic materials such as contrast media. UltraFlow HPC Flow: The device is intended for the controlled selective infusion of physician-specified pharmacologic agents or contrast media into the distal vasculature of the peripheral and neuroanatomy. It is not intended for use in the coronary vasculature. Catalog No. 105-5055V02 105-5055V02 105-5055V05 105-5065V02 105-5065V05 105-5066V02 105-5066V05

    FDA Enforcement
    Class I ·Terminated·Micro Therapeutics Inc, Dba Ev3 Neurovascular·November 16, 2016