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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
OHMEDA INOVENT DELIVERY SYSTEM OHMEDA MEDICAL DEN000001 Post-NSE AN 2000-01-07 2000-01-11
UROSURGE PERCUTANEOUS SANS (STOLLER AFFERENT NERVE STIMULATOR) DEVICE UROSURGE, INC. DEN000002 Post-NSE GU 2000-01-27 2000-02-09
QUICKAIR CHOKE RELIEVER, MODEL 59-001A MAET INDUSTRIES, INC. DEN000004 Post-NSE AN 2000-01-28 2000-02-29
EROS-CLITORAL THERAPY DEVICE (CTD) UROMETRICS, INC. DEN000006 Post-NSE OB 2000-04-27 2000-04-28
QUANTA LITE ASCA (S. CEREVISIAE) IGG ELISA INOVA DIAGNOSTICS, INC. DEN000007 Post-NSE IM 2000-07-18 2000-08-16
DULBECCO'S MODIFIED EAGLE MEDIUM (DMEM) LIFE TECHNOLOGIES, INC. DEN000008 Post-NSE GU 2000-12-19 2001-02-16
TRIAGE B-TYPE NATRIURETIC PEPTIDE (BNP) TEST BIOSITE INCORPORATED DEN000010 Post-NSE CH 2000-11-15 2000-11-20
GIVEN DIAGNOSTIC IMAGING SYSTEM GIVEN IMAGING LTD. DEN010002 Post-NSE GU 2001-06-11 2001-08-01
BREASTVIEW VISUAL MAPPING SYSTEM ASSURANCE MEDICAL DEN020001 Post-NSE OB 2002-05-28 2003-01-31
RETROX AURIC HEARING SYSTEMS, INC. DEN020003 Post-NSE EN 2002-06-21 2002-08-20
NIOX ARTICLE NO: 02-1000 AEROCRINE AB DEN030001 Post-NSE TX 2003-03-18 2003-04-30
ENDOTOXIN ACTIVITY ASSAY (EAA) DEVICE SPECTRAL DIAGNOSTICS, INC. DEN030002 Post-NSE MI 2003-04-14 2003-06-16
WEST NILE VIRUS IGM CAPTURE ELISA PANBIO LIMITED DEN030004 Post-NSE MI 2003-07-03 2003-07-08
FACTOR V LEIDEN KIT ROCHE DIAGNOSTICS CORP. DEN030005 Post-NSE HE 2003-12-08 2003-12-17
CELLSEARCH EPITHELIAL CELL ENRICHMENT KIT; CELLSPOTTER SYSTEM ADVANCED DIAGNOSTIC SYSTEMS DEN040001 Post-NSE IM 2004-01-02 2004-01-21
NEOGRAM AMINO ACIDS AND ACYLCARNITINES TANDEM MASS SPECTROMETRY KIT, MODEL MS-8970 PERKINELMER LIFE SCIENCES, INC. DEN040002 Post-NSE CH 2004-07-02 2004-08-24
GLUCATELL ASSOCIATES OF CAPE COD, INC. DEN040003 Post-NSE MI 2004-03-22 2004-05-21
CELLERATION MIST THERAPY SYSTEM CELLERATION DEN040004 Post-NSE SU 2004-04-29 2004-06-25
VERICHIP HEALTH INFORMATION MICROTRANSPONDER AND POCKET READER DIGITAL ANGEL CORPORATION DEN040007 Post-NSE HO 2004-08-04 2004-10-12
CEDIA SIROLIMUS ASSAY MICROGENICS CORP. DEN040008 Post-NSE TX 2004-06-17 2004-07-28