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「stent」检索 FDA 数据库。

共找到 37 条与「stent」匹配的结果

当前展示 37 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
Stent, Urethral, Bulbous, Permanent Or Semi-Permanent	III 类	MES	—	Unknown
Intracranial Coil-Assist Stent	III 类	QCA	—	Unknown	An intracranial coil-assist stent is a tubular device placed in an artery in the brain to assist in the placement and retention of embolic coils for the treatment of wide-neck intracranial aneurysms.
Gallbladder Drainage Stent And Delivery System	II 类	QXH	21 CFR 876.5016	Gastroenterology, Urology	A gallbladder drainage stent is a prescription device intended to facilitate transgastric or transduodenal endoscopic drainage of the gallbladder. This device may also include a delivery system.
Stent Graft, Infrapopliteal, Venous Arterialization	III 类	QWN	—	Unknown	For performing percutaneous arterialization of the deep veins to restore blood flow in the lower limbs
Biliary Stent, Drain, And Dilator Accessories	I 类	QGE	21 CFR 876.5012	Gastroenterology, Urology	Biliary stent, drain, and dilator accessories are manual devices that aid in the introduction and connection of biliary stents, drains, or dilators. This generic type of device includes the guiding catheter, pushing catheter, pigtail straightener, flap protector, nasal transfer tube, and drainage connecting tube.
Stent, Colonic, Metallic, Expandable	II 类	MQR	21 CFR 878.3610	General, Plastic Surgery
Iliac Covered Stent, Arterial	III 类	PRL	—	Unknown	For the treatment of de novo or restenotic lesions found in iliac arteries
Stent, Superficial Femoral Artery	III 类	NIP	—	Unknown	Stent, Superficial Femoral Artery -- a metal scaffold placed via a delivery catheter into the superficial femoral artery artery to maintain the lumen
Pancreatic Stent, Covered, Metallic, Removable	II 类	PCU	21 CFR 876.5015	Gastroenterology, Urology	To facilitate transmural endoscopic drainage of pancreatic pseudocysts
Stent, Central Venous	III 类	QKJ	—	Unknown	A central venous stent is a prescription device for maintaining the luminal diameter of the central veins.
Stent, Renal	III 类	NIN	—	Unknown	Stent, Renal -- a metal scaffold placed via a delivery catheter into the renal artery to maintain the lumen
Coronary Drug-Eluting Stent	III 类	NIQ	—	Unknown	Stent, coronary, drug-eluting -- a metal scaffold with a drug coating placed via a delivery catheter into the coronary artery or saphenous vein graft to maintain the lumen. The drug coating is intended to inhibit restenosis.
Stent, Coronary	III 类	MAF	—	Unknown	The formerly known device, Cardiovascular Stent, coded as "MAF" has been modified and is currently known and classified as a "Coronary Stent". This device is a metal scaffold placed via a delivery catheter into the coronary artery or saphenous vein graft to maintain the lumen.
Peripheral Temporary And Retrievable Stent System	II 类	SEU	21 CFR 870.5110	Cardiovascular	A peripheral temporary and retrievable stent system is a temporary scaffold placed into the peripheral vasculature via a delivery catheter system for treating stenotic lesions. The device is designed to be retrieved and removed following successful treatment.
Stent Graft, Bypass, Superficial Femoral Artery	III 类	QWM	—	Unknown	For bypassing stenosis in the superficial femoral artery via the femoral vein
Stent, Superficial Femoral Artery, Drug-Eluting	III 类	NIU	—	Unknown	Stent, Superficial Femoral Artery, Drug-Eluting -- a metal scaffold with a drug coating placed via a delivery catheter into the superficial femoral artery artery to maintain the lumen. The drug coating is intended to inhibit restenosis.
Stent, Iliac	III 类	NIO	—	Unknown	Stent, Iliac -- a metal scaffold placed via a delivery catheter into the iliac artery to maintain the lumen
Stent, Iliac Vein	III 类	QAN	—	Unknown	A metal scaffold placed via a delivery catheter in the iliac vein to maintain the lumen
Stent Delivery System	未分类	PKK	—	Unknown	For coarctation of the aorta
Hybrid Stent Graft, Thoracic Aortic Lesion Treatment	III 类	QSK	—	Unknown	Repair or replacement of damaged or diseased vessel of the aortic arch and descending thoracic aorta, with or without involvement of ascending aorta, using vascular grafts and/or stent grafts placed during open surgical repair.
Covered Stent Vascular Connector, Hemodialysis Access Circuit	III 类	SEQ	—	Unknown	The device is intended for suture-less attachment between an arteriovenous (AV) graft to a native vessel or between two native vessels (i.e., lack of suture placement on one or both ends) for the creation of a hemodialysis access site.
Absorbable Coronary Drug-Eluting Stent	III 类	PNY	—	Unknown	An absorbable scaffold with a drug coating placed via a delivery catheter into the coronary artery or saphenous vein graft to maintain the lumen. The drug coating is intended to inhibit restenosis.
Stent, Carotid	III 类	NIM	—	Unknown	Stent, Carotid -- a metal scaffold placed via a delivery catheter into the carotid artery to maintain the lumen
Stent, Bladder, Fetal	未分类	MPR	—	Unknown
Stent, Urethral, Prostatic, Permanent Or Semi-Permanent	III 类	MER	—	Unknown
Stent, Urethral, Prostatic, Semi-Permanent	III 类	NZC	—	Unknown	Approximately 3 cm tube placed in the prostatic urethra for short term use to drain urine. The device includes a retention mechanism that anchors in the bladder neck to hold it in place and a release mechanism that exits the penis. For short term use in men with partial of full prostatic urethral obstruction or the prevention of prostatic urethral obstruction post surgery or other prostatic treatment.
Ureteral Stent Accessories	I 类	QGB	21 CFR 876.4630	Gastroenterology, Urology	Ureteral stent accessories aid in the insertion of the ureteral stent that is placed into the ureter to provide ureteral rigidity and allow the passage of urine. This generic type of device includes the stent positioner, wire guide, and pigtail straightener.
Stent, Urethral, External Sphincter, Permanent	III 类	MXQ	—	Unknown
Stent, Vaginal	II 类	KXP	21 CFR 884.3900	Obstetrics/Gynecology
Stent, Metallic, Expandable, Duodenal	II 类	MUM	21 CFR 878.3610	General, Plastic Surgery
Biliary Stent System For Benign Strictures	II 类	PNB	21 CFR 876.5011	Gastroenterology, Urology	A benign stricture biliary stent system is a prescription device intended for treatment of benign biliary strictures. Stents are intended to be left indwelling for a limited amount of time and subsequently removed. The device consists of a metal stent and a delivery system intended to place the stent in the biliary ducts.
Aortic Stent	III 类	PNF	—	Unknown	Coarctation of the Aorta
Coronary Covered Stent	未分类	NIV	—	Unknown	Stent, coronary, covered -- a metal scaffold covered with material placed via a delivery catheter into the coronary artery artery or saphenous vein graft for the treatment of free perforations and/or to prevent dislodgement into the circulation of biological material from the vascular wall during or following placement of the device.
Intracranial Neurovascular Stent	未分类	NJE	—	Unknown	An intracranial neurovascular stent is a tubular device placed in the blood vessel of the intracranial cavity to treat a vascular abnormality. It differs from other stents in that it is intended for intracranial use.
Pulmonary Stent	III 类	QWC	—	Unknown	A pulmonary stent is a metal scaffold placed via a delivery catheter into the pulmonary artery to maintain the lumen.
Stent, Ureteral	II 类	FAD	21 CFR 876.4620	Gastroenterology, Urology
Drug-Eluting Sinus Stent	III 类	OWO	—	Unknown	Mechanically maintain patency following ethmoid sinus surgery. By also eluting drugs, reduce the need for post-operative intervention such as surgical adhesion lysis and/or use of oral steroids.

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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