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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: 07/22/2019
 
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abiomed 23 fr sheath Abiomed Inc. K201116 06/15/2020
acuitypdr Radmedix LLC K200726 04/13/2020
acuson sequoia diagnostic ultrasound system Siemens Medical Solutions USA, Inc K201462 06/24/2020
allwin embryo transfer catheters (etc), allwin etc stylets and soft obturators Allwin Medical Devices, Inc. K200248 07/01/2020
amf revision tt cones LimaCorporate S.p.A K200653 05/07/2020
andorate biopsy valve, andorate biopsy irrigator GA Health Company Limited K200481 06/18/2020
aptima combo 2 assay (panther) - 250 test kit, aptima combo 2 assay (tigris) - 250 test kit, aptima trichomonas vaginalis (panther) - 250 test kit, aptima trichomonas vaginalis (tigris) - 250 test kit Hologic, Inc. K200436 03/23/2020
aspire max 7 - 11f mechanical thrombectomy system and aspire mechanical aspirator Control Medical Technology K200871 05/04/2020
automated blood cell separators: Aurora Xi Plasmapheresis System/Aurora Xi/Aurora Xi system/Aurora Xi Fresenius Kabi AG BK200478 05/07/2020
axis spine technologies alif Axis Spine Technologies Ltd K200352 05/20/2020

*   The maximium 500 devices meeting your search criteria returned. Please narrow your search.
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