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「blood pressure」检索 FDA 数据库。
共找到 909 条与「blood pressure」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 |
|---|---|---|---|---|---|---|
| K160019 | U80 Series Upper Arm Electronic Blood Pressure Monitor | Shenzhen Urion Technology Co., Ltd. | 2016-04-22 | Substantially Equivalent | DXN | Cardiovascular |
| K073445 | CLEVER TD-3026 DIGITAL WRIST BLOOD PRESSURE MONITOR, MODEL TD-3026 | Taidoc Technology Corporation | 2008-04-02 | Substantially Equivalent | DXN | Cardiovascular |
| K102825 | BLOOD PRESSURE CUFF | APK Technology Co., Ltd. | 2011-03-02 | Substantially Equivalent | DXQ | Cardiovascular |
| K062027 | A&D MEDICAL UA-789 DIGITAL BLOOD PRESSURE MONITOR | A&D Engineering, Inc. | 2007-01-19 | Substantially Equivalent | DXN | Cardiovascular |
| K914273 | A&D TM-2421/2021 AMBULATORY BLOOD PRESSURE MONITOR | A&D Engineering, Inc. | 1993-02-09 | Substantially Equivalent | DSK | Cardiovascular |
| K032499 | A & D MEDICAL LIFESOURCE UA-704 DIGITAL BLOOD PRESSURE MONITORS | A&D Engineering, Inc. | 2003-10-30 | Substantially Equivalent | DXN | Cardiovascular |
| K063137 | PHARMASMART PUBLIC USE BLOOD PRESSURE MONITOR, MODELS PS-1000/PS-1500/PS-2000 | Pharmasmart, Inc. | 2007-05-01 | Substantially Equivalent | DXN | Cardiovascular |
| K232621 | Blood pressure monitor | Guangdong Transtek Medical Electronics Co., Ltd. | 2023-11-22 | Substantially Equivalent | DXN | Cardiovascular |
| K093592 | ADVOCATE REDI-COD DUO BLOOD GLUCOSE PLUS BLOOD PRESSURE MONITORING SYSTEM, MODEL TD-3223 | Taidoc Technology Corporation | 2010-02-25 | Substantially Equivalent | NBW | Clinical Chemistry |
| K131121 | FULL AUTOMATIC (NIBP) BLOOD PRESSURE MONITOR | Health & Life Co., Ltd. | 2013-05-29 | Substantially Equivalent | DXN | Cardiovascular |
| K150373 | Digital Automatic Blood Pressure Monitor BPM25 & BPM26 Series [Model No.: MD25x0/ MD26x0] | Grandway Technology (Shenzhen) Limited | 2015-06-11 | Substantially Equivalent | DXN | Cardiovascular |
| K802412 | BLOOD PRESSURE UNIT MODEL 410 | Js & A Group | 1980-12-16 | Substantially Equivalent | DXN | Cardiovascular |
| K021252 | BLOOD-PRESSURE METER | Idt Technology Limited | 2002-06-17 | Substantially Equivalent | DXN | Cardiovascular |
| K014141 | DIGIBIO DIGTIAL BLOOD PRESSURE MONITOR MODEL D11 | Digibio Technology Corp. | 2002-09-13 | Substantially Equivalent | DXN | Cardiovascular |
| K182127 | Wrist Blood Pressure Monitor Model BP6100 | Omron Healthcare, Inc. | 2018-11-02 | Substantially Equivalent | DXN | Cardiovascular |
| K251581 | Wearable Ambulatory Blood Pressure Monitor (WBP-02A) | Shenzhen Hingmed Medical Instrument Co., Ltd. | 2026-02-13 | Substantially Equivalent | DXN | Cardiovascular |
| K041689 | POLYURETHANE BLOOD PRESSURE CUFFS | D. E. Hokanson, Inc. | 2004-08-06 | Substantially Equivalent | DXQ | Cardiovascular |
| K061935 | SENSACARE SAW-102 WRIST DIGITAL BLOOD PRESSURE MONITOR | Sensacare , Ltd. | 2006-11-08 | Substantially Equivalent | DXN | Cardiovascular |
| K231478 | Digital Blood Pressure Monitor (Model: YB-800) | Wenzhou Yosun Medical Technology Co.,Ltd | 2023-12-15 | Substantially Equivalent | DXN | Cardiovascular |
| K163679 | Digital Automatic Blood Pressure Monitor MD3600 | Grandway Technology (Shenzhen) Limited | 2017-06-07 | Substantially Equivalent | DXN | Cardiovascular |
| K222994 | Arm Blood Pressure Monitor, models AOJ-33A and AOJ-33B | Shenzhen AOJ Medical Technology Co., Ltd. | 2023-07-26 | Substantially Equivalent | DXN | Cardiovascular |
| K253133 | Wrist Blood Pressure Monitor (BPM-W1VL) | Shenzhen Imdk Medical Technology Co., Ltd. | 2026-02-13 | Substantially Equivalent | DXN | Cardiovascular |
| K003711 | AMBULATORY BLOOD PRESSURE MONITORING SYSTEM, MODEL SE-25M/25P | Sein Electronics Co., Ltd. | 2000-12-15 | Substantially Equivalent | DXN | Cardiovascular |
| K102939 | FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR MODEL KD-931 | Andon Health Co, Ltd. | 2011-02-23 | Substantially Equivalent | DXN | Cardiovascular |
| K061959 | MYTECH / HAPPY LIFE / MAXIAIDS ARM BLOOD PRESSURE MONITOR, HPL-301, HPL-302, HPL-310, 180310 | Mytech Technology Co., Ltd. | 2006-08-22 | Substantially Equivalent | DXN | Cardiovascular |
| K122401 | TANGO M2 BLOOD PRESSURE MONITOR | Suntech Medical, Inc. | 2012-11-02 | Substantially Equivalent | DXN | Cardiovascular |
| K081590 | YA HORNG ARM TYPE DIGITAL BLOOD PRESSURE MONITOR, MODELS BP-600, BP-600R, BP-600U, BP-600B, BP-600RB, BP-600UB, BP-600J | Ya Horng Electronic Co., Ltd. | 2008-06-19 | Substantially Equivalent | DXN | Cardiovascular |
| K072049 | CONTINUOUS NON-INVASIVE CARDIAC OUTPUT AND BLOOD PRESSURE MONITOR WITH REAL-TIME HEMODYNAMICS | Bmeye B.V. | 2007-11-29 | Substantially Equivalent | DXN | Cardiovascular |
| K160557 | Full Automatic (NIBP) Blood Pressure Monitor | Health & Life Co., Ltd. | 2016-07-06 | Substantially Equivalent | DXN | Cardiovascular |
| K222658 | Accurate 24 Non-invasive blood pressure monitor | Accurate Meditech, Inc. | 2023-06-21 | Substantially Equivalent | DXN | Cardiovascular |
| K230176 | Upper Arm Blood Pressure Monitor | Shenzhen Yolanda Technology Co., Ltd. | 2023-06-29 | Substantially Equivalent | DXN | Cardiovascular |
| K052154 | OMRON AUTOMATIC BLOOD PRESSURE MONITOR, MODEL HEM-711AC | Omron Healthcare, Inc. | 2005-09-08 | Substantially Equivalent | DXN | Cardiovascular |
| K002046 | MODIFICATION TO AUTOMATED NON-INVASIVE BLOOD PRESSURE MONITOR, MODEL BPM-100 | Vsm Technology, Inc. | 2000-07-21 | Substantially Equivalent | DXN | Cardiovascular |
| K936313 | CMS-90 BLOOD PRESSURE MEASUREMENT ASSISTANT | Prevention Sciences | 1994-07-20 | Substantially Equivalent | DXQ | Cardiovascular |
| K110872 | WITHINGS BLOOD PRESSURE MONITOR | Withings | 2011-05-20 | Substantially Equivalent | DXN | Cardiovascular |
| K053395 | BP PRO BLOOD PRESSURE MONITOR | Card Guard Scientific Survival , Ltd. | 2005-12-23 | Substantially Equivalent | DXN | Cardiovascular |
| K260260 | Automatic Digital Blood Pressure Monitor (LD-587, LD-528, LD-562, LD-581, LD-521, LD-527, LD-572 & LD-569) | Honsun (Nantong) Co., Ltd. | 2026-04-28 | Substantially Equivalent | DXN | Cardiovascular |
| K852037 | NORELCO ELECTRONIC DIGITAL BLOOD PRESSURE METER | Philips Park | 1985-06-11 | Substantially Equivalent | DXN | Cardiovascular |
| K002954 | RI-SAN/RI-SANA BLOOD PRESSURE MANOMETERS | Rudolf Riester GmbH & Co. KG | 2000-12-21 | Substantially Equivalent | DXQ | Cardiovascular |
| K061161 | BLOOD PRESSURE METER, MODEL CH-311B | Citizen Watch Co., Ltd. | 2006-06-26 | Substantially Equivalent | DXN | Cardiovascular |
| K103046 | HOSMAN USB BLOOD PRESSURE MONITOR; WRIST TYPE AND UPPER ARM TYPE | Hosman International Co., Ltd. | 2011-01-10 | Substantially Equivalent | DXN | Cardiovascular |
| K090027 | BLOOD PRESSURE MONITOR, ZSBP-003/004/005/006/007/008 AND ZSBP-102/103/104/105/106/107 | Zen Strong Medical Technology Co., Ltd. | 2009-02-02 | Substantially Equivalent | DXN | Cardiovascular |
| K160945 | Endophys Blood Pressure Monitor | Endophys Holdings, LLC | 2016-09-26 | Substantially Equivalent | DSK | Cardiovascular |
| K223170 | Electronic Blood Pressure Monitor, model: HTD6602US | Hetaida Technology Co., Ltd. | 2023-12-05 | Substantially Equivalent | DXN | Cardiovascular |
| K170466 | Automatic Blood Pressure Monitor Model LD-518 & LD-537 | Honsun (Nantong) Co., Ltd. | 2017-10-27 | Substantially Equivalent | DXN | Cardiovascular |
| K112691 | BLOOD PRESSURE MONITOR | Nihon Seimitsu Sokki Co., Ltd. | 2012-02-24 | Substantially Equivalent | DXN | Cardiovascular |
| K041778 | REIZEN TALKING BLOOD PRESSURE MONITOR, MODEL #SF860T | Maxi-Aids, Inc. | 2004-08-31 | Substantially Equivalent | DXN | Cardiovascular |
| K241578 | Wrist Digital Blood Pressure Monitor (BSX312, BSX313, BSX315, BSX322, BSX323, BSX353, BSX355) | Shenzhen Bsx Technology Electronics Co., Ltd. | 2025-02-19 | Substantially Equivalent | DXN | Cardiovascular |
| K200297 | Microlife Upper Arm Automatic Digital Blood Pressure Monitor | Microlife Intellectual Property GmbH | 2020-06-18 | Substantially Equivalent | DXN | Cardiovascular |
| K761274 | BLOOD PRESSURE KIT, WELL-BE 669 | Pearlduck, Inc. | 1977-01-05 | Substantially Equivalent | DXN | Cardiovascular |
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。