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「syringe」检索 FDA 数据库。

共找到 986 条与「syringe」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
K904923	INFUSA T SYRINGE INFUSION PUMP	Ferguson Medical	1991-09-06	Substantially Equivalent	FRN	General Hospital
K220114	PowerPAK Syringe	Vault Paragon Group, Inc.	2023-01-25	Substantially Equivalent	MEG	General Hospital
K952407	REDI NURSE SYSTEM (RNS) PRE-FILLED 10CC, 30CC, 60CC SYRINGE W/STERILE WATER	Contour Fabricators of Florida, Inc.	1995-08-07	Substantially Equivalent	KYZ	General Hospital
K031394	AMERICAN SYRINGE COMPANY 1CC AND 3CC SYRINGE	American Syringe Company	2003-07-25	Substantially Equivalent	FMF	General Hospital
K791729	SYRINGE INFUSION PUMP	Princeton Medical Instruments, Inc.	1979-10-01	Substantially Equivalent	FRN	General Hospital
K072654	PATIENT SAFE SYRINGE	Retractable Technologies, Inc.	2007-12-14	Substantially Equivalent	FMF	General Hospital
K212226	DR Safety Syringe, Sterile Hypodermic needle for Single use	Zhuhai DR Medical Instruments Co., Ltd.	2021-09-29	Substantially Equivalent	MEG	General Hospital
K160855	U&U Enteral Syringe	U&U Medical Technology Co, Ltd.	2016-11-22	Substantially Equivalent	PNR	Gastroenterology, Urology
K181374	NRFit Syringe	Jiangsu Caina Medical Co.,Ltd	2018-12-14	Substantially Equivalent	QEH	General Hospital
K841361	SYRINGE ADDITIVE IV ADMIN. SETS	Quest Medical, Inc.	1984-05-21	Substantially Equivalent	FPA	General Hospital
K860746	AUTO SYRINGE MICRO VOL EXT SET W/AIR VENT FILTER	Travenol Laboratories, S.A.	1986-04-07	Substantially Equivalent	FPB	General Hospital
K946219	POP-N-LOK SYRINGE	Retractable Technologies, Inc.	1995-12-28	Substantially Equivalent	MEG	General Hospital
K761229	ANAL/RECTAL SYRINGE	Ace Orthopedic Manufacturing Co.	1977-02-24	Substantially Equivalent	KOA	Gastroenterology, Urology
K002142	SALINE IV FLUSH SYRINGE	Emt-Rx	2002-01-28	Substantially Equivalent	FOZ	General Hospital
K173743	Greenmedi Safety Filter Syringe	Sang-A Frontec Co., Ltd.	2019-01-28	Substantially Equivalent	MEG	General Hospital
K830898	SYRINGE 500BC BE #7000	Instrumentation Industries, Inc.	1983-05-16	Substantially Equivalent	BXW	Anesthesiology
K873410	DISPOSABLE ANGIOGRAPHIC, CONTROL SYRINGE	Blood Gas Supply Co.	1988-03-25	Substantially Equivalent	DXT	Cardiovascular
K260208	Ultra-Fine SAFETY Insulin Syringe	embecta Medical II, LLC	2026-07-13	Substantially Equivalent	FMF	General Hospital
K023752	BD INTEGRA SYRINGE	Bd	2003-02-07	Substantially Equivalent	FMF	General Hospital
K210464	Auto Disable Syringe	Anhui Tiankang Medical Technology Co., Ltd.	2021-08-24	Substantially Equivalent	FMF	General Hospital
K170651	Sterile Disposable Syringe with Safety Needle, Sterile Disposable Syringe with Needle, Sterile Disposable Syringe, Sterile Disposable Safety Needle, Sterile Disposable Needle	Yangzhou Medline Industry, Co., Ltd.	2017-08-02	Substantially Equivalent	MEG	General Hospital
K881521	MODIFIED SERVO SYRINGE	Engineering, Inc.	1988-05-31	Substantially Equivalent	DXT	Cardiovascular
K890155	MDP DISPOSABLE SYRINGE	Mediplas Marketing	1989-02-24	Substantially Equivalent	FMF	General Hospital
K904620	STERAID DISPOSABLE SYRINGE	Disposable Medi-Aids , Ltd.	1991-03-15	Substantially Equivalent	FMF	General Hospital
K875122	DISPOSABLE STERILE SYRINGE FILTERS	Corning Medical & Scientific	1988-01-12	Substantially Equivalent	KET	Pathology
K871007	ANTI NEEDLE STRIKE ANTI DRUG ABUSE HYPO. SYRINGE	Habley Medical Technology Corp.	1987-04-30	Substantially Equivalent	FMF	General Hospital
K904508	CONDOR ANALOG INFLATION SYRINGE	Professional Medical Services	1991-04-02	Substantially Equivalent	MAV	Cardiovascular
K040899	MEDEX 3000 SERIES MR SYRINGE INFUSION PUMP	Medex, Inc.	2004-04-30	Substantially Equivalent	FRN	General Hospital
K212262	PCA Syringe Sets	Baxter Healthcare Corporation	2022-10-03	Substantially Equivalent	FPA	General Hospital
K843415	TOP HYPODERMIC SYRINGE LUER LOCK	Top Surgical Manufacturers Co.	1984-12-07	Substantially Equivalent	FMF	General Hospital
K971924	BLUNT SYRINGE CANNULA	B.Braun Medical, Inc.	1998-09-25	Substantially Equivalent	FMI	General Hospital
K241856	Sofjec (Single use Needle); Sofjec (Single use Syringe with or without Needle); Sofjec (Membrane Filter Syringe)	Hlb Lifescience Co., Ltd.	2024-12-23	Substantially Equivalent	FMF	General Hospital
K233069	Removal System Large Bore 60 cc Syringe	Inari Medical, Inc.	2024-03-26	Substantially Equivalent	PUR	General Hospital
K213013	Sterile Single-use LDV Syringe, CHOICARE Sterile Single-use LDV Syringe	Jeil Tech Co., Ltd.	2022-09-19	Substantially Equivalent	QNQ	General Hospital
K850488	STRATOFUSE SYRINGE PIGGYBACK PUMP 1030	Strato Medical Corp.	1985-03-21	Substantially Equivalent	FRN	General Hospital
K111386	MEDFUSION MODEL 4000 SYRINGE INFUSION PUMP, PHARMGUARD TOOLBOX 2 MEDICATION SAFETY SOFTWARE AND SUPPORTED SYRINGES (PSS)	Smiths Medical MD, Inc.	2011-08-29	Substantially Equivalent	FRN	General Hospital
K832778	EPIDURAL SYRINGE	Concord Laboratories, Inc.	1983-09-26	Substantially Equivalent	CAZ	Anesthesiology
K161812	Freedom Syringe	Procedure Products, Inc.	2017-03-27	Substantially Equivalent	FMF	General Hospital
K843414	TOP HYPODERMIC SYRINGE PISTON	Top Surgical Manufacturers Co.	1984-09-07	Substantially Equivalent	FMF	General Hospital
K151766	BD Single Use, Hypodermic Syringe	Becton, Dickinson and Company	2015-09-02	Substantially Equivalent	FMF	General Hospital
K163591	BD PosiFlush Heparin Lock Flush Syringe	Becton, Dickinson and Company	2017-02-27	Substantially Equivalent	NZW	General Hospital
K790803	SYRINGE TONOMETER	Medicor USA , Ltd.	1979-06-28	Substantially Equivalent		Unknown
K972452	RAMY INTEGRATED NEEDLE SYRINGE	Alshifa Medical Syringes Mfg. Co., Ltd.	1997-07-24	Substantially Equivalent	FMF	General Hospital
K203321	Cystoject Syringe Lever	Urogen Pharma, Ltd.	2020-12-09	Substantially Equivalent	QBL	General Hospital
K873746	AUTO SYRINGE MODEL AS20G INFUSION PUMP	Baxter Healthcare Corp	1988-01-06	Substantially Equivalent	FRN	General Hospital
K203359	BD Flu+ Syringe	Becton, Dickinson and Company	2021-07-28	Substantially Equivalent	FMF	General Hospital
K112475	XTRACT SYRINGE KEY SYSTEM	Xtract Solutions	2011-11-10	Substantially Equivalent	FMF	General Hospital
K923285	PRO-TIP DISPOSABLE 3/1 SYRINGE NOZZLE	Smith & Nephew, Inc.	1992-09-15	Substantially Equivalent	ECB	Dental
K901203	HYPODERMIC SYRINGE LUER LOK	Ware-Medics Glass Works, Inc.	1990-06-06	Substantially Equivalent	FMF	General Hospital
K111381	MEDI-SIS SYRINGE INFUSION SYSTEM	Acacia, Inc.	2012-01-13	Substantially Equivalent	LZH	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。

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