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U.S. Department of Health and Human Services

510(k) Premarket Notification

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1 to 10 of 500 Results *
Decision Date To: 07/04/2022
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2-way 100% silicone cleartract catheter Silq Technologies Corporation K221625 07/01/2022
acqmap high resolution imaging and mapping system Acutus Medical, Inc. K220784 07/01/2022
astroglide warming BioFilm Inc. K221036 07/01/2022
bd perisafe tuohy epidural needle, bd perisafe weiss epidural needle Becton, Dickinson and Company K211085 07/01/2022
bladder scanner, model name:m5 Suzhou Peaksonic Medical Technology Co., Ltd. K213488 07/01/2022
cerrozone mobile CerroZone K220298 07/01/2022
crosslead peripheral guide wire Asahi Intecc Co., LTD. K213315 07/01/2022
dental diode laser, soga laser, ilaser ii Shenzhen Soga Technology Co., Ltd. K211150 07/01/2022
ennovate cervical spinal and occiput system Aesculap Implant Systems, LLC. K213871 07/01/2022
ent nasopharyngoscope and accessories Medimaging Integrated Solution Inc. (MiiS) K214050 07/01/2022

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