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U.S. Department of Health and Human Services

510(K) Premarket Notification

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gtk disposable needle guides GEOTEK Medikal Ltd Sti k170741 06/01/2017
nova statsensor creatinine hospital meter system Nova Biomedical Corporation k171059 05/26/2017
arrow seldinger arterial catheterization device 18 ga., arrow seldinger arterial catheterization device 20 ga., arrow seldinger arterial catheterization device 22 ga., arrow seldinger arterial catheterization device 24 ga. Arrow International, Inc. (Subsidiary of Telelflex Inc.) k171146 06/23/2017
neo pedicle screw system™ Neo Medical S.A. k171582 09/12/2017
smartlinx vitals plus nibp module, smartlinx vitals plus license for spot monitoring mode, smartlinx vitals plus alarm hub, smartlinx vitals plus license for advanced monitoring mode, covidien filac 3000 - temperature module Capsule Technologie, SAS k171751 10/24/2017
cleancision wound retraction and protection system Prescient Surgical, Inc. k172132 10/25/2017
ageless health medical digital thermometer Ageless Health Industrial Co., Ltd k172508 08/08/2018
syncvision system Volcano Corporation k172574 10/05/2017
p20 series digital color doppler ultrasound system Sonoscape Medical Corp. k172993 12/05/2017
medline sterile water usp and medline sterile 0.9% normal saline usp Medline Industries, Inc. k173276 07/02/2018

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