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U.S. Department of Health and Human Services

510(K) Premarket Notification
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510(K)
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ageless health medical digital thermometer Ageless Health Industrial Co., Ltd k172508 08/08/2018
medline sterile water usp and medline sterile 0.9% normal saline usp Medline Industries, Inc. k173276 07/02/2018
signature orthodontic system Signature Orthodontics k181271 06/13/2018
sterilization pouch/roll made with tyvek Sigma Medical Supplies Corporation k180672 06/06/2018
medline green ambidextrous powder-free nitrile examination gloves with colloidal oatmeal (tested for use with chemotherapy drugs) Medline Industries, Inc. k180696 04/30/2018
summit hip system DePuy Orthopaedics, Inc. k170339 04/26/2018
pico single use negative pressure wound therapy system Smith & Nephew Medical Limited k180614 04/06/2018
p20 series digital color doppler ultrasound system Sonoscape Medical Corp. k172993 12/05/2017
cleancision wound retraction and protection system Prescient Surgical, Inc. k172132 10/25/2017
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

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