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U.S. Department of Health and Human Services

510(k) Premarket Notification

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31 to 40 of 500 Results *
Decision Date To: 07/22/2019
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blue sky bio zygomatic implant system Blue Sky Bio, LLC. K190491 08/12/2019
bonebridge system, bone conduction implant kit (bci 602 implant kit), bci 602 sizer kit, bci 602 lifts (1mm) MED-EL Elektromedizinische Geraete GmbH K191457 09/18/2019
bonus therapeutics mixing and delivery system Bonus Therapeutics Ltd. K190996 07/28/2019
brilliant everglow flow Coltene/Whaledent AG K190597 06/21/2019
btl-084 BTL Industries, Inc. K190023 03/29/2019
buhlmann fcal turbo and calex cap BUHLMANN Laboratories AG K191718 09/24/2019
cancellex porous titanium lumbar interbody device Xenco Medical, LLC K190364 04/18/2019
carnation ambulatory monitor Bardy Diagnostics, Inc K191471 08/30/2019
celerity hp chemical indicator, celerity vaporized vh2o2 process indicator adhesive label, verify v24 self-contained biological indicator vial label STERIS Corporation K192020 09/05/2019
centrimag acute circulatory support system Thoratec Corporation (now part of Abbott) K191557 07/10/2019

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