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

查询器械在 FDA 的管理类别（I/II/III 类）、产品代码与 21 CFR 法规号，是判断注册路径（豁免 / 510(k) / PMA）的第一步。

已将中文关键词转为英文「syringe」检索 FDA 数据库。

共找到 31 条与「syringe」匹配的结果

当前展示 31 条FDA 器械分类记录；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 ›

器械名称	管理类别	产品代码	法规号（21 CFR）	所属科室	定义 / 用途
Epinephrine Syringe	II 类	PQX	21 CFR 880.5860	General Hospital	Intended for intramuscular or subcutaneous injection of epinephrine.
Piston Syringe With Neuraxial Connector Epidural, Peripheral, And/Or Indirect Cerebral Spinal Fluid Contact	II 类	QEH	21 CFR 880.5860	General Hospital	A neuraxial piston syringe is intended to inject or withdraw fluid from the neuraxial space with neuraxial specific connections. This product code may include epidural, peripheral, subarachnoid/spinal block, intrathecal and/or intracerebroventricular administration routes. The connector for neuraxial applications is intended to facilitate ANSI/AAMI/ISO 80369-6:2016 compliant neuraxial specific connections.
Syringe, Piston, Reprocessed	II 类	NKN	21 CFR 880.5860	General Hospital	A piston syringe is a device intended for medical purposes that consists of a calibrated hollow barrel and a movable plunger. At one end of the barrel there is a male connector (nozzle) for fitting the female connector (hub) of a hypodermic single lumen needle. The device is used to inject fluids into, or withdraw fluids from, the body. Reprocessing validation data for this device type must be included in a 510(k) submission. (70 FR 56911, available at https://www.govinfo.gov/content/pkg/FR-2005-09-29/pdf/05-19510.pdf).
Syringe, Irrigating (Non Dental)	I 类	KYZ	21 CFR 880.6960	General Hospital
Injector And Syringe, Angiographic, Balloon Inflation, Reprocessed	II 类	NKU	21 CFR 870.1650	Cardiovascular
Adaptor, Holder, Syringe	I 类	IQG	21 CFR 890.5050	Physical Medicine
Syringe, Balloon Inflation, Exempt	II 类	PTM	21 CFR 870.1650	Cardiovascular	This product code is the class II exempt counterpart of MAV, and was exempted, subject to the limitations of exemption, under the procedures established by the 21st Century Cures Act. This device type does not require premarket notification (510(k)) to market if it does not exceed the general limitations of exemption found in 21 CFR 870.9 and the specific limitations of exemption as stated in the Physical State field of this product code description.
Syringe, Ent	I 类	KCP	21 CFR 874.5220	Ear, Nose, Throat
Catheter, Infusion, Syringe	II 类	NPG	21 CFR 870.1210	Cardiovascular	To provide physician specified fluids both perivascular or intraluminal to the perivascular space.
Unit, Syringe, Air And/Or Water	I 类	ECB	21 CFR 872.4565	Dental
Anti-Stick Glass Syringe	未分类	PGO	—	Unknown	Single use devices that are indicated for use as an accessory with sterile 1ML long staked needle prefilled ISO standard glass syringes to aid in the protection of healthcare professionals, patients who self-inject, doctor prescribed medications, and individuals that assist self-injecting patients from accidental needle sticks. Can be used on a wide range of patients including children and adults.
Syringe, Balloon Inflation	II 类	MAV	21 CFR 870.1650	Cardiovascular
Syringe, Piston	II 类	FMF	21 CFR 880.5860	General Hospital
Ophthalmic Syringe	II 类	QLY	21 CFR 880.5860	General Hospital	An Ophthalmic Syringe is a piston syringe intended for intraocular injections. The device consists of a calibrated hollow barrel, a movable plunger, and may include a needle. The device should be used by health care professionals to perform injections into the eye.
Syringe, Restorative And Impression Material	I 类	EID	21 CFR 872.4565	Dental
Low Dead Space Piston Syringe	II 类	QNQ	21 CFR 880.5860	General Hospital	A low dead space syringe is a piston syringe designed to reduce medication waste. The device consists of a calibrated hollow barrel, a moveable plunger, and may include a needle. The device can be used by health care professions or for self-injection by the patient.
Syringe, Cartridge	II 类	EJI	21 CFR 872.6770	Dental
Bone Void Filler, Syringe	未分类	PBU	—	Unknown	To fill bony voids or gaps of the skeletal system (i.e. the extremities, posterolateral spine and pelvis).
Pump, Infusion Or Syringe, Extra-Luminal	II 类	FIH	21 CFR 876.5820	Gastroenterology, Urology
Syringe, Irrigating (Dental)	I 类	EIB	21 CFR 872.4565	Dental
Actuator, Syringe, For Injector, Reprocessed	II 类	NKW	21 CFR 870.1670	Cardiovascular	Reprocessing validation data for this device type must be included in a 510(k) submission. (70 FR 56911, available at https://www.govinfo.gov/content/pkg/FR-2005-09-29/pdf/05-19510.pdf).
Holder, Syringe, Lead	I 类	IWR	21 CFR 892.6500	Radiology
Introducer, Syringe Needle	II 类	KZH	21 CFR 880.6920	General Hospital
Injector And Syringe, Angiographic	II 类	DXT	21 CFR 870.1650	Cardiovascular
Piston Syringe Lever	II 类	QBL	21 CFR 880.5860	General Hospital	Controlled compression of a piston syringe
Injector And Syringe, Angiographic, Reprocessed	II 类	NKT	21 CFR 870.1650	Cardiovascular	Reprocessing validation data for this device type must be included in a 510(k) submission. (70 FR 56911, available at https://www.govinfo.gov/content/pkg/FR-2005-09-29/pdf/05-19510.pdf).
Syringe, Periodontic, Endodontic, Irrigating	I 类	EIC	21 CFR 872.4565	Dental
Actuator, Syringe, Injector Type	II 类	DQF	21 CFR 870.1670	Cardiovascular
Midazolam Syringe	II 类	QDM	21 CFR 880.5860	General Hospital	Intended for intramuscular injection of midazolam.
Vacuum Syringe	II 类	PUR	21 CFR 880.5860	General Hospital	The vacuum syringe is intended to be used as a general purpose syringe for injection and withdrawal of fluids and can be locked in place to create a vacuum for removal of fluid and/or tissue from the body in the form of thrombus, abscess fluid, and infected fluid.
Syringe, Antistick	II 类	MEG	21 CFR 880.5860	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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