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。
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「blood pressure」检索 FDA 数据库。
共找到 11 条与「blood pressure」匹配的结果
当前展示 11 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 |
|---|---|---|---|---|---|
| Manometer, Blood-Pressure, Venous | II 类 | KRK | 21 CFR 870.1140 | Cardiovascular | |
| Reprocessed Blood Pressure Cuff | II 类 | NPP | 21 CFR 870.1120 | Cardiovascular | The intended use for the reprocessed/reused blood pressure cuff is use in manual measurement and automatic non-invasive blood pressure monitoring by properly trained personnel. Complete inflation systems are designed for use with manometers during manual bp measurement. |
| Blood Pressure Cuff | II 类 | DXQ | 21 CFR 870.1120 | Cardiovascular | A blood pressure cuff is a device that has an inflatable bladder in an elastic sleeve (cuff) with a mechanism for inflating the bladder. The cuff is used to determine a subject's blood pressure. |
| Controller, Closed-Loop, Blood-Pressure | III 类 | LSX | — | Unknown | |
| Neonatal Icu Continuous Non-Invasive Blood Pressure Monitor (Includes Alarms) | II 类 | QYF | 21 CFR 870.1130 | Cardiovascular | The Neonatal ICU continuous non-invasive blood pressure monitor is a prescription device used by medical professionals that measures non-invasive continuous cuffless blood pressure in neonates in the NICU who have a palpable pulse. The device requires calibration. This device is intended for use in conjunction with SpO2 monitoring and is not indicated for ambulatory monitoring. |
| Alarm, Blood-Pressure | II 类 | DSJ | 21 CFR 870.1100 | Cardiovascular | |
| Transducer, Blood-Pressure, Extravascular | II 类 | DRS | 21 CFR 870.2850 | Cardiovascular | |
| System, Measurement, Blood-Pressure, Non-Invasive | II 类 | DXN | 21 CFR 870.1130 | Cardiovascular | |
| Computer, Blood-Pressure | II 类 | DSK | 21 CFR 870.1110 | Cardiovascular | |
| Central Venous Blood Pressure Kit | II 类 | OFE | 21 CFR 870.1140 | Cardiovascular | This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at www.Fda.Gov/cdrh/ode/convkit.Html. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance. |
| Antimicrobial Blood Pressure Cuff | II 类 | OED | 21 CFR 870.1120 | Cardiovascular | Device is a replacement cuff to be used in conjunction with a non-invasive blood pressure monitor. Together the devices determine blood pressures and heart rate. This particular cuff contains an embedded antimicrobial. A blood pressure cuff is a device that has an inflatable bladder in an elastic sleeve(cuff) with a mechanism for inflating the bladder. The cuff is used to determine a subject's blood pressure. |
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。