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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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human iga liquid reagent kit for use on spaplus The Binding Site Group Ltd k192116 09/04/2019
blue latex examination powder free gloves JR Engineering & Medical Technologies (M) SDN.BHD. k192329 11/25/2019
liaison® folate Diasorin Inc. k192586 05/06/2020
i_space 1.5t superconducting magnetic resonance imaging system MRI Division, Beijing Wandong Medical Technology Co., Ltd. k192650 01/29/2021
depuy corail amt hip prosthesis DePuy Orthopaedics, Inc. k192946 11/26/2019
emprint ablation system with thermosphere technology, emprint sx ablation platform with thermosphere technology Covidien LLC k193232 02/13/2020
cardiochek plus test system; cardiochek plus home test system Polymer Technology Systems, Inc. d/b/a PTS Diagnostics k193406 02/26/2022
acuson juniper diagnostic ultrasound system Siemens Medical Solutions USA, Inc. k180039 02/01/2018
omnipore duromax surgical implants Matrix Surgical Holdings, LLC/Matrix Surgical USA k180249 10/11/2018
infrared thermometer Xuzhou Yongkang Electronic Science Technology Co., Ltd k180314 07/11/2018

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