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。
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「stent」检索 FDA 数据库。
共找到 521 条与「stent」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 |
|---|---|---|---|---|---|---|
| K243830 | Disposable ureteral stent | Shenzhen Trious Medical Technology Co., Ltd. | 2025-05-14 | Substantially Equivalent | FAD | Gastroenterology, Urology |
| K213186 | NovoFlow Reinforced Ureteral Stent | Coloplast Corp. | 2022-02-16 | Unknown | FAD | Gastroenterology, Urology |
| K081996 | FLEXSTENT BILIARY SELF EXPANDING STENT SYSTEM | Flexible Stenting Solutions, Inc. | 2009-09-15 | Unknown | FGE | Gastroenterology, Urology |
| K983075 | GUIDANT MEGALINK BILIARY STENT, MODEL #'S 1002949-18, 1002949-28, 1002949-38 | Guidant Corp. | 1999-03-03 | Unknown | FGE | Gastroenterology, Urology |
| K073266 | WALLFLEX PARTIALLY COVERED ESOPHAGEAL STENT SYSTEM | Boston Scientific Corp | 2008-02-27 | Substantially Equivalent | ESW | General, Plastic Surgery |
| K233837 | Agile Esophageal Stent System | Boston Scientific Corporation | 2024-04-04 | Substantially Equivalent | ESW | General, Plastic Surgery |
| K952527 | BALLOON UTERINE STENT | Cook Urological, Inc. | 1996-01-02 | Substantially Equivalent | KNA | Obstetrics/Gynecology |
| K123205 | ESOPHAGEAL TTS STENT | Taewoong Medical Co., Ltd. | 2013-10-09 | Substantially Equivalent | ESW | General, Plastic Surgery |
| K812255 | ETHICON LACRIMAL STENT | ETHICON, Inc. | 1981-08-20 | Substantially Equivalent | HNL | Ophthalmic |
| K042204 | MODIFICATION TO PROTEGE GPS SELF-EXPANDING NITINOL STENT | Ev3, Inc. | 2004-08-23 | Unknown | FGE | Gastroenterology, Urology |
| K951803 | ROSSITER SINUS STENT | Smith & Nephew Richards, Inc. | 1995-05-11 | Substantially Equivalent | KAM | General, Plastic Surgery |
| K974479 | SILIMED VAGINAL STENT | Silimed, LLC | 1998-08-05 | Substantially Equivalent | KXP | Obstetrics/Gynecology |
| K882157 | PANAMEX(TM) URETERAL STENT | Kingston Technologies, Inc. | 1988-08-02 | Substantially Equivalent | FAD | Gastroenterology, Urology |
| DEN240048 | Spur Peripheral Retrievable Stent System | Reflow Medical, Inc. | 2025-05-29 | Unknown | SEU | Cardiovascular |
| K080838 | ALVEOLUS ALIMAXX-E ESOPHAGEAL STENT SYSTEM | Alveolus, Inc. | 2008-04-24 | Substantially Equivalent | ESW | General, Plastic Surgery |
| K202477 | EndoGI S-Path Biliary Stent System | Endo GI Medical | 2020-09-24 | Substantially Equivalent | FGE | Gastroenterology, Urology |
| K001257 | INTRACOIL STENT | Intratherapeutics, Inc. | 2000-05-18 | Substantially Equivalent | JCT | General, Plastic Surgery |
| K951066 | RAINS FRONTAL SINUS STENT | Smith & Nephew Richards, Inc. | 1995-04-04 | Substantially Equivalent | KAM | General, Plastic Surgery |
| K060323 | ULTRAFLEX PRECISION COLONIC STENT, MODELS M00557330, MO00557360, M00557380 | Boston Scientific Corporation | 2006-05-12 | Substantially Equivalent | MQR | General, Plastic Surgery |
| K223354 | EGIS Biliary Single Bare Stent | S&G Biotech, Inc. | 2023-09-21 | Unknown | FGE | Gastroenterology, Urology |
| K963254 | SYMPHONY NITINOL STENT TRANSHEPATIC BILIARY SYSTEM | Boston Scientific Corp | 1997-05-21 | Substantially Equivalent | FGE | Gastroenterology, Urology |
| K021994 | BARD CONFORMEXX BILIARY STENT AND DELIVERY SYSTEM | C.R. Bard, Inc. | 2003-01-02 | Unknown | FGE | Gastroenterology, Urology |
| K203162 | Advanix Biliary Stent with NaviFlex RX Delivery System | Boston Scientific Corporation | 2020-12-18 | Substantially Equivalent | FGE | Gastroenterology, Urology |
| K172278 | Firlit-Kluge Urethral Stent, Koyle Diaper Stent, Zaontz Urethral Stent | Cook Incorporated | 2017-11-22 | Substantially Equivalent | GBM | Gastroenterology, Urology |
| K914280 | ECHOSIGHT STENT SET | Cook Urological, Inc. | 1992-01-09 | Substantially Equivalent | FAD | Gastroenterology, Urology |
| K851870 | MENTOR UNIVERSAL URETERAL STENT SET | Mentor Corp. | 1985-07-02 | Substantially Equivalent | FAD | Gastroenterology, Urology |
| K072708 | ABSOLUTE PRO .035 SELF-EXPANDING STENT SYSTEM | Abbott Vascular-Vascular Solutions | 2008-08-18 | Unknown | FGE | Gastroenterology, Urology |
| K061235 | LIFESTENT TURBO BILIARY STENT SYSTEM | Edwards Lifesciences, LLC | 2006-06-05 | Unknown | FGE | Gastroenterology, Urology |
| K113551 | ESOPHAGEAL TTS STENT | Taewoong Medical Co., Ltd. | 2012-02-14 | Substantially Equivalent | ESW | General, Plastic Surgery |
| K030633 | MEDTRONIC AVE BRIDGE CONSTANT BILIARY STENT SYSTEM OR ('CONSTANT | Medtronic Ave, Inc. | 2003-09-02 | Unknown | FGE | Gastroenterology, Urology |
| K111766 | SUPERA VERITAS INTERWOVEN SELF-EXPANDING NITINOL STENT TRANSHEPTIC BILIARY SYSTEMS | Idev Technologies, Inc. | 2011-10-19 | Unknown | FGE | Gastroenterology, Urology |
| K921191 | GIANTURCO-ROSCH BILIARY Z STENT | Cook, Inc. | 1992-05-15 | Substantially Equivalent | FGE | Gastroenterology, Urology |
| K010107 | R STENT BILIARY ENDOPROSTHESIS | Orbus Medical Technologies | 2001-07-31 | Unknown | FGE | Gastroenterology, Urology |
| K002130 | NIR BILIARY STENT | Medinol, Ltd. | 2000-10-30 | Unknown | FGE | Gastroenterology, Urology |
| K993646 | S.M.A.R.T. .018 NITINOL STENT TRANSHEPATIC BILIARY SYSTEM | Cordis Corp. | 1999-11-28 | Unknown | FGE | Gastroenterology, Urology |
| K024048 | MODIFICATION TO BOSTON SCIENTIFIC EXPRESS BILIARY LD PREMOUNTED STENT SYSTEM | Boston Scientific Scimed, Inc. | 2003-01-06 | Unknown | FGE | Gastroenterology, Urology |
| K840059 | SILITEK URINARY DIVERSION STENT | Surgitek | 1984-02-04 | Substantially Equivalent | FAD | Gastroenterology, Urology |
| K014184 | MODIFICATION TO DYNALINK .035 BILIARY SELF-EXPANDING STENT SYSTEM | Guidant Corp. | 2002-01-18 | Unknown | FGE | Gastroenterology, Urology |
| K120452 | FLEXSTENT BILIARY SELF-EXPANDING STENT SYSTEM | Flexible Stenting Solutions, Inc. | 2012-04-24 | Unknown | FGE | Gastroenterology, Urology |
| K141704 | NOVASHIELD INJECTABLE NASAL PACKING AND STENT | Medtronic, Inc. | 2014-10-06 | Substantially Equivalent | LYA | Ear, Nose, Throat |
| K091510 | WALLFLEX ESOPHAGEAL FULLY COVERED STENT SYSTEM, MODELS M00516700, M00516710, M00516720, M00516730 | Boston Scientific Corporation | 2009-06-26 | Substantially Equivalent | ESW | General, Plastic Surgery |
| K091624 | STENT GRAFT BALLOON CATHETER | Via Biomedical, Inc. | 2009-10-15 | Substantially Equivalent | DQY | Cardiovascular |
| K133700 | ADVANIX PANCREATIC STENT AND NAVIFLEX RAPID EXCHANGE PANCREATIC DELIVERY SYSTEM AND PUSHERS | Boston Scientific Corporation | 2014-05-14 | Substantially Equivalent | FGE | Gastroenterology, Urology |
| K141344 | EXPEL NEPHROURETERAL DRAINAGE STENT WITH TWIST-LOC HUB SYSTEM, EXPEL URETERAL DRAINAGE STENT SYSTEM | Boston Scientific Corp | 2014-10-17 | Substantially Equivalent | FAD | Gastroenterology, Urology |
| K002133 | NIR BILLIARY STENT SYSTEM; MARSHAL BALLOON DILATATION CATHETER | Boston Scientific Corp | 2000-10-12 | Unknown | FGE | Gastroenterology, Urology |
| K223469 | WallFlex Biliary RX Stent System | Boston Scientific Corporation | 2023-06-15 | Unknown | FGE | Gastroenterology, Urology |
| K083627 | WALLFLEX BILIARY RX FULLY-COVERED STENT SYSTEM, MODEL M00570500,M00570510, M00570520, M00570530, M00570540 | Boston Scientific Corporation | 2009-04-07 | Unknown | FGE | Gastroenterology, Urology |
| K060817 | OMNILINK. 018 BILIARY STENT SYSTEM | Guidant Endovascular Solutions, Inc. | 2006-06-15 | Unknown | FGE | Gastroenterology, Urology |
| K823418 | HEYER-SCHUTE UNIVERSAL URETERAL STENT | American Hospital Supply Corp. | 1982-12-03 | Substantially Equivalent | LJE | Unknown |
| K182980 | Zilver 518 Biliary Stent, Zilver 635 Biliary Stent | Cook Ireland, Ltd. | 2018-11-16 | Unknown | FGE | Gastroenterology, Urology |
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。