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U.S. Department of Health and Human Services

510(k) Premarket Notification

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11 to 20 of 500 Results *
Decision Date To: 05/21/2019
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980nm diode laser therapy device Shanghai Apolo Medical Technology Co., Ltd. K191349 08/16/2019
eq balance Highmark Innovations Inc. DBA Highmark Interactive K190735 08/16/2019
tria soft ureteral stent Boston Scientific Corporation K191609 08/16/2019
vyntus body Vyaire Medical Inc. K190853 08/16/2019
compact intuitiv system, compact intuitiv wireless remote control, compact intuitiv four-button foot pedal, compact intuitiv closed-toe foot pedal Johnson & Johnson Surgical Vision, Inc. K191933 08/16/2019
glucose hk gen.3, ise indirect na for gen.2, elecsys tsh, cobas pro integrated solutions Roche Diagnostics K191899 08/16/2019
gim-stim otc tens/ems system Gemore Technology Co Ltd K190988 08/16/2019
choicespine octane a/t/p spinal implant system, choicespine cervical interbody spacer system ascendant pc, choicespine cervical interbody spacer system ascendant, choicespine cervical spacer system blackhawk, choicespine intervertebral fusion device octane straight, choicespine intervertebral fusio ChoiceSpine, LLC K191621 08/15/2019
stryker cmf medpor priority customized implant kit Stryker Leibinger GmbH & Co. KG K191916 08/15/2019
reprocessed harmonic focus shears + adaptive tissue technology Sterilmed, Inc. K190610 08/15/2019

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