FDA器械上市前通知/批准

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上市前通知

器械名称

申请人

510(K)编号

类型

咨询委员会

收到日

决定日

上市前批准

器械名称

申请人

器械商品名

PMA编号

补编号

咨询委员会

收到日

决定日

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
CAST MATERIAL (WICKET STOCKINETTE)	ZIMMER, INC.	K760003	Traditional	PM	1976-05-26	1976-07-26
ARCH SUPPORT (ARCH AID)	ZIMMER, INC.	K760001	Traditional		1976-05-26	1976-07-26
KNEE AID	ZIMMER, INC.	K760002	Traditional	PM	1976-05-26	1976-07-26
SYRINGE, DISPOSABLE, GLASS & PLASTIC	STEWART-NAUMANN LABORATORIES	K760005	Traditional	HO	1976-06-07	1976-08-23
SYRINGE, DISPOSABLE, ALL PLASTIC	STEWART-NAUMANN LABORATORIES	K760004	Traditional	HO	1976-06-07	1976-08-23
RADIOASSAY, CONCEPT 4	MICROMEDIC SYSTEMS	K760006	Traditional		1976-06-07	1976-07-20
BLOOD-SMEARING INSTRUMENT (MINIPREP TM)	GEOMETRIC DATA, DIV. SMITHKLINE CORP.	K760007	Traditional	HE	1976-06-08	1976-09-03
DENTAL MATERIAL, IMPLANT, HIGH-PURITY AL	KYOCERA INTERNATIONAL, INC.	K760008	Traditional	DE	1976-06-08	1976-10-05
PACER SYSTEMS ANALYZER (CORDIS)	CORDIS CORP.	K760013	Traditional	CV	1976-06-10	1976-07-20
COLORIMETRIC DETERMINATION (SGOT/SGPT)	THE DOW CHEMICAL CO.	K760010	Traditional	CH	1976-06-10	1976-07-26
COLORIMETRIC DETERMINATION (LDH)	THE DOW CHEMICAL CO.	K760009	Traditional	CH	1976-06-10	1976-07-20
REAGENT, TRIGLYCERIDES	THE DOW CHEMICAL CO.	K760011	Traditional	CH	1976-06-10	1976-07-26
BLOOD WARMER (CODE 4R4305)	TRAVENOL LABORATORIES, S.A.	K760012	Traditional	HE	1976-06-10	1976-07-16
VACUUM TUBES, PEDIATRIC SIZES (J-VAC)	JELCO LABORATORIES	K760019	Traditional	CH	1976-06-11	1976-07-20
CONSIOUS SEDATION (ANALOR P-76)	MCKESSON CORP.	K760017	Traditional	AN	1976-06-11	1976-07-20
SURGICAL BLADES (BEAVER)	PARKE-DAVIS CO.	K760016	Traditional		1976-06-11	1976-07-16
VACUUM TUBES, STERILE (J-VAC)	JELCO LABORATORIES	K760018	Traditional	CH	1976-06-11	1976-07-20
ULTRAZYME HBD	HARLECO	K760023	Traditional	CH	1976-06-14	1976-08-26
ULTRAZYME ALKALINE PHOSPHATASE	HARLECO	K760024	Traditional	CH	1976-06-14	1976-08-26
NEEDLE, FILTER	JELCO LABORATORIES	K760022	Traditional	SU	1976-06-14	1976-08-09