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U.S. Department of Health and Human Services

510(k) Premarket Notification

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81 to 90 of 500 Results *
Decision Date To: 05/21/2019
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prostep tbc implant system Wright Medical Technology, Inc. K183620 06/06/2019
automated blood cell separators: ALYX 2RBC LR Kit fresenius kabi usa llc. BK190351 06/06/2019
compas2 (computerized pulmonary analysis system) Morgan Scientific, Inc. K190568 06/06/2019
da vinci handheld camera Intuitive Surgical, Inc. K191043 06/06/2019
idys alif tivac Clariance SAS K191263 06/06/2019
rigel peek anterior cervical interbody fusion system MiRus, LLC K190618 06/06/2019
luminelle dtx hysteroscopy system, luminelle 360 rotatable sterile disposable sheath rigid UVision360 Inc. K190827 06/06/2019
vitek 2 ast-gram positive dalbavancin (<= 0.015 - >= 1 µg/ml) bioMerieux, Inc. K190616 06/06/2019
fibrin sealant preparation device: VISTASEAL™ Laparoscopic Dual Applicator (35 cm Rigid or 45 cm Flexible) ethicon inc. BK190324 06/05/2019
watchpat one Itamar Medical, Ltd. K183559 06/05/2019

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