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上市前通知
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上市前批准
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注:

       列表页默认显示“上市前通知”检索项下的内容;

       上市前通知(510(K))是指通过对拟上市产品与已上市产品在安全性和有效性方面进行比较,在得出实质性等同(Substantial Equivalence,简称SE)结论的前提下,进而获得拟上市产品可以合法销售的上市前通告的一条法规路径,适合于第一类、第二类、少部分三类医疗器械。

       上市前批准(PMA)是FDA按照科学性和法规要求,评价第三类医疗器械安全性和有效性的审批程序。

    


器械名称 申请人 510K号码 类型 医学分类 收到日 决定日
Nio Color 3MP (MDNC-3421) Barco NV K170837 Special RA 2017-03-21 2017-04-05
ORTHOPANTOMOGRAPH OP 3D PaloDEx Group Oy K170813 Traditional RA 2017-03-17 2017-04-07
MX50N(MX50YQS) WIDE Corporation K170781 Traditional RA 2017-03-15 2017-04-04
CX50N(CX50YQS) WIDE Corporation K170783 Traditional RA 2017-03-15 2017-03-31
System, X-Ray, Extra oral Source, Digital, PaX-i Plus, PaX-i Insight Vatech Co., Ltd K170731 Traditional DE 2017-03-10 2017-04-04
AngioDynamics Total Abscession Biliary Drainage Catheter AngioDynamics, Inc. K170743 Special GU 2017-03-10 2017-03-30
Anzai Respiratory Gating System Anzai Medical Co., Ltd. K170719 Special RA 2017-03-09 2017-04-05
NeuroBlate System Monteris Medical K170724 Special SU 2017-03-09 2017-04-07
GEN_2 and GEN_3 Mechanical Wheelchairs Free Wheelchair Mission K170701 Special PM 2017-03-08 2017-03-24
Inqwire Diagnostic Guide Wire Merit Medical Systems Inc. K170700 Special CV 2017-03-07 2017-04-06
HeartSpan Steerable Sheath Introducer Merit Medical Systems, Inc. K170668 Special CV 2017-03-06 2017-04-05
Neurovision Nerve Locator Monitor (Nerveana), EMGView Software Neurovision Medical Product Inc. K170677 Special NE 2017-03-06 2017-04-05
Beta-CrossLaps CalCheck 5 Roche Diagnostics K170678 Traditional CH 2017-03-06 2017-04-04
USS System Synthes USA Products LLC K170654 Special OR 2017-03-03 2017-03-29
BioMonitor 2-AF, BioMonitor 2-S BIOTRONIK, Inc K170628 Special CV 2017-03-02 2017-03-31
Chameleon PTA Balloon Catheter AV Medical Technologies Ltd K170635 Special CV 2017-03-02 2017-03-30
Fathom-16 Steerable Guidewires Boston Scientific Corporation K170636 Special CV 2017-03-02 2017-03-22
ZeroWire Mobile NDS Surgical Imaging, LLC. K170598 Special GU 2017-03-01 2017-04-07
Bakri Postpartum Balloon, Bakri Postpartum Balloon with Rapid Instillation Component Cook Incorporated K170622 Special OB 2017-03-01 2017-03-31
Intersept Filtered Cardiotomy Reservoir with Cortiva BioActive Surface Medtronic, Inc. K170583 Special CV 2017-02-28 2017-03-17