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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: 05/21/2019
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additive cap International Medical Industries, Inc. K190305 04/30/2019
amplatzer treviso intravascular delivery system Abbott Medical K190581 04/05/2019
aptis medical distal radio ulnar joint implant Aptis Medical, LLC K190599 05/03/2019
arthrex swivelock anchors Arthrex Inc. K190728 04/17/2019
arthrex swivelock suture anchor Arthrex Inc. K191226 06/11/2019
auragen 123 suction lipoplasty system (a123) AuraGen Aesthetics LLC K190278 05/03/2019
biocode gastrointestinal pathogen panel (gpp) Applied Biocode, Inc. K190585 06/05/2019
briefcase Aidoc Medical, Ltd. K190072 04/15/2019
brilliant everglow flow Coltene/Whaledent AG K190597 06/21/2019
c2 cryoballoon catheter (pear), c2 cryoballoon (standard), c2 cryoballoon controller, c2 cryoballoon foot pedal, c2 cryoballoon cartridge PENTAX Medical, A Division of PENTAX of America, Inc. K190194 05/31/2019

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