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U.S. Department of Health and Human Services

510(k) Premarket Notification

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21 to 30 of 500 Results *
Decision Date To: 07/22/2019
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study watch with irregular pulse monitor Verily Life Sciences LLC K192415 01/17/2020
black diamond navigation instruments Osseus Fusion Systems K192495 01/17/2020
colink plating system, fracture and correction system, colink mini plating system, colink view plating system, colink afx plating system In2Bones USA, LLC K193543 01/17/2020
mahurkar acute single lumen catheter, mahurkar acute dual lumen catheter, mahurkar acute triple lumen catheter, mahurkar acute high pressure triple lumen catheter Covidien, llc K192302 01/17/2020
rxsight insertion device RxSight, Inc. K192926 01/17/2020
glidescope bflex 3.8 single-use bronchoscope Verathon Medical (Canada) ULC K193488 01/16/2020
resectr tissue resection device Boston Scientific Corporation K191538 01/16/2020
actiflip naked, actiflip cinch, actiflip whip, gfs ultimate hip Parcus Medical, LLC K192750 01/16/2020
innovo Atlantic Therapeutics Ltd. K192357 01/16/2020
viveve 2.0 system Viveve Medical, Inc. K193611 01/16/2020

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