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U.S. Department of Health and Human Services

510(K) Premarket Notification

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bladder scanner (model: padscan ds3, padscan z3, padscan z5) Avantsonic Technology Co., Ltd. k171528 01/24/2018
electrodes with snap / electrodes with pigtail Shenzhen Konmed Technology Co., Ltd k171722 01/10/2018
clover 50/clover60/clover70 diagnostic ultrasound system SHENZHEN WISONIC MEDICAL TECHNOLOGY CO., LTD. k163712 01/02/2018
seaspine spacer system (nanometalene)- hollywood, hollywood vi, ventura, pacifica; seaspine spacer system -hollywood, hollywood vi, ventura, pacifica; seaspine vu e·pod system SeaSpine Orthopedics Corporation k173260 12/04/2017
hemodraw plus closed blood sampling system with logical transducer kit, hemodraw plus closed blood sampling system with transtar transducer kit Smiths Medical ASD, Inc. k172458 11/09/2017
construx® mini ptc spacer system, forza® ptc spacer system, pillar® sa ptc spacer system Orthofix Inc. k172437 11/02/2017
sterile nitrile surgical powder free gloves tested for use with chemotherapy drugs and sterile latex surgical powder free gloves Top Glove SDN BHD k171279 10/12/2017
combo stimulator mt9000, combo stimulator lt7102, tens stimulator intensity 10 Shenzhen Dongdixin Technology Co., Ltd. k171978 10/02/2017
winback back 3se WINBACK USA CORP k162828 09/18/2017
nivairo rt045 non-vented hospital full face mask anti-asphyxiation valve - large, nivairo rt045 non-vented hospital full face mask anti-asphyxiation valve - medium, nivairo rt045 non-vented hospital full face mask anti-asphyxiation valve - small, nivairo rt045 non-vented hospital full face mask ant Fisher and Paykel Healthcare Limited k170367 08/24/2017

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