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U.S. Department of Health and Human Services

510(K) Premarket Notification
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spiral flow vascular arteriovenous graft Vascular Flow Technologies, Ltd. k141124 05/30/2014
biodentine Septodont k140132 06/27/2014
pilot pro diode laser CAO Group, Inc. k142223 09/12/2014
uni npwt foam dressing kit, uni npwt foam dressing kit, uni npwt foam dressing kit Blue Ocean Medical Product, LLC k133333 12/31/2014
new era orthopaedics polyscrew pedicle screw system New Era Orthopaedics, LLC k141253 01/09/2015
medical monofilament sensory screening toool Medical Monofilament Manufacturing k143068 01/14/2015
eva,anterior machine, eva, combined machine, eva combined machine with laser(dorc connector), eva combined machine with laser sma connector) Dutch Ophthalmic Research Center International BV k142877 03/13/2015
integra (r) jarit (r) kerrison rongeurs, integra (r) ruggles (tm)-redmons (tm) kerrison rongeurs, integra (r) miltex (r) kerrison rongeurs, integra (r) meisterhand (r) kerrison rongeurs Integra Lifesciences Corp. k150428 04/16/2015
divergence-l anterior/oblique lumbar fusion system Medtronic Sofamor Danek USA, Inc. k150135 06/11/2015
tek rmd (tek robotic mobilization device) Matia Robotics Mekatroik Sis. Ar-Ge Muh. Yaz.San VE Tic.A.S k150548 06/11/2015

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