FDA 药品与器械查询

实时对接美国 FDA 官方开放数据（openFDA），可查询美国上市药品 NDC 目录、医疗器械管理类别与 21 CFR 法规号、以及已获许可的 510(k) 清单，用于出海美国的准入判断、注册路径选择与同类竞品调研。支持中文关键词自动转英文检索。

数据源：美国 FDA 官方开放数据平台 openFDA，实时查询美国上市药品 NDC 目录、器械分类与 510(k) 许可，用于出海美国的准入与合规自查。

支持中文关键词自动转英文检索；此为美国监管口径，与中国 NMPA 批准情况相互独立。

上市药品（NDC）器械分类 510(k) 许可

检索已获 FDA 上市前通告许可的器械清单，可查看同类产品的申请人、K 号与许可日期，用于竞品与等效器械调研。

已将中文关键词转为英文「insulin」检索 FDA 数据库。

共找到 285 条与「insulin」匹配的结果

当前展示 50 条FDA 510(k) 许可记录；海关数据库提供全球买卖明细与竞争对手出货记录咨询完整数据 ›

K 号	器械名称	申请人	许可日期	结论	产品代码	审查科室
K841573	INSULIN RADIOIMMUNOASSAY KIT	Sorin Biomedica, Fiat, USA, Inc.	1984-05-16	Substantially Equivalent	CFP	Clinical Chemistry
K230043	Insulin Pen Needle	Anhui Hongyu Wuzhou Medical Manufacturer Co., Ltd.	2023-09-20	Substantially Equivalent	FMI	General Hospital
K153706	Insulin Pen Needle	SteriLance Medical (Suzhou), Inc.	2016-08-29	Substantially Equivalent	FMI	General Hospital
K260208	Ultra-Fine SAFETY Insulin Syringe	embecta Medical II, LLC	2026-07-13	Substantially Equivalent	FMF	General Hospital
K162296	OmniPod Insulin Management System	Insulet Corporation	2017-04-18	Substantially Equivalent	LZG	General Hospital
K141758	T:SLIM INSULIN DELIVERY SYSTEM	Tandem Diabetes Care, Inc.	2014-10-31	Substantially Equivalent	LZG	General Hospital
K041317	MODIFICATION TO MEDTRONIC MINIMED PARADIGM MODEL 512 INSULIN PUMP	Medtronic Minimed	2004-07-19	Substantially Equivalent	LZG	General Hospital
K790630	RIA, INSULIN, DOUBLE ANTIBODY	Endocrine-Metabolic Center	1979-07-24	Substantially Equivalent	CFP	Clinical Chemistry
K962956	MEDI-JECTOR CHOICE NEEDLE-FREE INSULIN DELIVERY SYSTEM	Medi-Ject Corp.	1996-10-07	Substantially Equivalent	KZE	General Hospital
K122953	OMNIPOD INSULIN MANAGMENT SYSTEM	Insulet Corporation	2012-12-07	Substantially Equivalent	LZG	General Hospital
K193273	Insulin Syringe	Promisemed Hangzhou Meditech Co., Ltd.	2021-01-05	Substantially Equivalent	FMF	General Hospital
K861250	MESULIN, INSULIN INFUSION SET	Molnlycke A/S Hospital Products	1986-05-23	Substantially Equivalent	FPA	General Hospital
K160252	OmniPod Insulin Management System	Insulet Corporation	2016-04-27	Substantially Equivalent	LZG	General Hospital
K191679	Omnipod DASH Insulin Management System with interoperable technology	Insulet Corporation	2019-09-20	Substantially Equivalent	QFG	Clinical Chemistry
K010890	BD ULTRA-FINE II INSULIN SYRINGE-MINI NEEDLE, MODEL 30G * 3/16 (5MM)	Becton, Dickinson and Co.	2001-04-19	Substantially Equivalent	FMF	General Hospital
K790409	LOW DEAD SPACE INSULIN SYRINGE	Pharmaseal Div., Baxter Healthcare Corp.	1979-04-24	Substantially Equivalent	FMF	General Hospital
K261672	twiist Automated Insulin Delivery (AID) System	Deka Research and Development	2026-06-17	Substantially Equivalent	QFG	Clinical Chemistry
K151090	CPL Insulin Pen Needle	Cpl Co., Ltd.	2016-09-21	Substantially Equivalent	FMI	General Hospital
K013104	SIMPLICITY QD SOFT INFUSION SET FOR USE BY PEOPLE WITH DIABETES IN INFUSE INSULIN SUBCUTANEOUSLY FROM A PUMP OR SYRINGE	Sterling Medivations, Inc.	2001-10-02	Substantially Equivalent	FPA	General Hospital
K060876	ACCU-CHEK INSULIN PUMP CONFIGURATION SOFTWARE (STANDARD), MODEL 04625137001; ACCU-CHEK INSULIN PUMP CONFIGURATION SOFTWA	Disetronic Medical Systems AG	2006-06-15	Substantially Equivalent	LZG	General Hospital
K223213	Tandem Mobi Insulin Pump with Interoperable Technology	Tandem Diabetes Care, Inc.	2023-07-10	Substantially Equivalent	QFG	Clinical Chemistry
K191490	Retractable Safety Syringe, Retractable Safety Insulin Syringe, Retractable Safety Tuberculin Syringe, Retractable Safety Allergy Syringe	Jiangsu Caina Medical Co.,Ltd	2019-10-03	Substantially Equivalent	MEG	General Hospital
K872805	NOVOLINPEN DIAL-A-DOSE INSULIN DELIVERY SYSTEM	Squibb-Novo, Inc.	1987-10-09	Substantially Equivalent	FMF	General Hospital
K222739	Disposable Insulin Pen Needle	Hantech Medical Device Co., Ltd.	2023-04-06	Substantially Equivalent	FMI	General Hospital
K071459	B. BRAUN PISTON SYRINGES AND OMNICAN AND OMNIFIX INSULIN SYRINGES	B.Braun Medical, Inc.	2007-08-16	Substantially Equivalent	FMF	General Hospital
K161950	Common Type Insulin Pen Needle, Safety Type Insulin Pen Needle	Promisemed Hangzhou Meditech Co., Ltd.	2017-05-11	Substantially Equivalent	FMI	General Hospital
K870018	E-Z JECT INSULIN SYRINGE	Can-Am Surgical Corp.	1987-02-04	Substantially Equivalent	FMF	General Hospital
K001906	ELECSYS INSULIN CALSET	Roche Diagnostics Corp.	2000-07-13	Substantially Equivalent	JIS	Clinical Chemistry
K840082	STERILE INSULIN DISPOS. NEEDLE/SYRINGE	Lee Medical Intl., Inc.	1984-02-21	Substantially Equivalent	FMF	General Hospital
K231907	Medline Safety Insulin and TB Syringes	Medline Industries, LP	2023-10-18	Substantially Equivalent	MEG	General Hospital
K223453	Insulin Syringe	Promisemed Hangzhou Meditech Co., Ltd.	2023-03-02	Substantially Equivalent	FMF	General Hospital
K032257	MODEL IR 1200 INSULIN PUMP	Animas Corp.	2003-10-16	Substantially Equivalent	LZG	General Hospital
K221176	Insulin Pen Needle	Tianjin Huahong Technology Co., Ltd.	2022-07-01	Substantially Equivalent	FMI	General Hospital
K984017	ALLISON MEDICAL INSULIN SYRINGE (AMIS)	Allison Medical, Inc.	1999-03-04	Substantially Equivalent	FMF	General Hospital
K811144	ARIA II INSULIN RIA	Bd Becton Dickinson Vacutainer Systems Preanalytic	1981-05-15	Substantially Equivalent	CFP	Clinical Chemistry
K223376	Monoject Magellan Insulin Safety Syringe 1mL, 31G x 6mm (8881893110); Monoject Magellan Insulin Safety Syringe 0.5mL, 31G x 6mm (8881893150); Monoject Magellan Insulin Safety Syringe 0.3mL, 31G x 6mm (8881893130)	Cardinal Health200, LLC	2023-06-21	Substantially Equivalent	MEG	General Hospital
K955235	B-D ULTRA FINE II, MICRO FINE + SHORT NEEDLE INSULIN SYRINGE	Bd Becton Dickinson Vacutainer Systems Preanalytic	1996-02-12	Substantially Equivalent	FMI	General Hospital
K211575	Omnipod® Insulin Management System, Omnipod DASH® Insulin Management System	Insulet Corporation	2021-08-13	Substantially Equivalent	LZG	General Hospital
K133058	INSULIN PEN NEEDLE	Wenzhou Wuzhou Import & Export Co., Ltd.	2014-02-25	Substantially Equivalent	FMI	General Hospital
K884978	PHARMA-PLAST INSULIN INFUSION SET	Pharma-Plast USA, Inc.	1989-06-21	Substantially Equivalent	LZG	General Hospital
K232380	t:slim X2 Insulin Pump with Interoperable Technology	Tandem Diabetes Care, Inc.	2023-11-03	Substantially Equivalent	QFG	Clinical Chemistry
K223372	Omnipod GO Insulin Delivery Device	Insulet Corporation	2023-04-24	Substantially Equivalent	LZG	General Hospital
K853838	JMS LCC INSULIN SYRINGE	Jms Co., Ltd.	1985-10-16	Substantially Equivalent	FMF	General Hospital
K091474	EASY.TOUCH INSULIN SYRINGE	Masters Healthcare, LLC	2009-07-09	Substantially Equivalent	FMF	General Hospital
K963948	MINIMED INSULIN PUMP, MODEL 505	Medtronic Minimed	1997-04-08	Substantially Equivalent - Subject to Tracking Reg.	LZG	General Hospital
K030531	MEDTRONIC MINIMED PARADIGM MODEL 512 INSULIN PUMP AND THE BD PARADIGM LINK GLUCOSE METER	Minimed, Inc.	2003-06-17	Substantially Equivalent	LZG	General Hospital
K993184	R1000 SERIES INSULIN PUMP	Animas Corp.	2000-02-10	Substantially Equivalent	LZG	General Hospital
K152808	U&U Insulin Syringe with/without Safety Retractable Device	U&U Medical Technology Co, Ltd.	2016-03-25	Substantially Equivalent	MEG	General Hospital
K202319	Insulin Pen Needle (Ordinary Type), Insulin Pen Needle (Safety Type)	Tianjin Huahong Technology Co., Ltd.	2021-11-12	Substantially Equivalent	FMI	General Hospital
K871807	BARD MICROINFUSER I INSULIN INFUSION PUMP	C.R. Bard, Inc.	1987-12-16	Substantially Equivalent	FRN	General Hospital

数据随 FDA 官方库更新，仅供参考，不构成医学或法律建议；正式注册与报关请以 FDA 官方文件及最新法规为准。

有产品想卖到海外？

用海关数据看清全球医药贸易——买家、规模、价格与竞争对手动向，一查便知。

了解海关数据服务查看出海指南