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「mask」检索 FDA 数据库。
共找到 14 条与「mask」匹配的结果
当前展示 14 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 |
|---|---|---|---|---|---|
| Mask, Scavenging | I 类 | KHA | 21 CFR 868.5590 | Anesthesiology | |
| Mask, Gas, Anesthetic | I 类 | BSJ | 21 CFR 868.5550 | Anesthesiology | |
| Strap, Head, Gas Mask | I 类 | BTK | 21 CFR 868.5560 | Anesthesiology | |
| Mask, Surgical | II 类 | FXX | 21 CFR 878.4040 | General, Plastic Surgery | |
| Mask, Oxygen | I 类 | BYG | 21 CFR 868.5580 | Anesthesiology | |
| Humidifier, Respiratory, Mask (Direct Patient Interface) | II 类 | OBN | 21 CFR 868.5450 | Anesthesiology | Intended to moderate blood pressure in hypertensive patients when they are exposed to the cold. The mask attenuates (moderates) the physiological response, increases in blood pressure, associated with cold exposure, by warming the inhaled air during cold exposure for individuals with hypertension, medicated or non-medicated. |
| Mask, Surgical, Eua Authorized | 未分类 | QMF | — | Unknown | Surgical masks for use in healthcare settings by HCP as PPE to provide a physical barrier to fluids and particulate materials to prevent HCP exposure to respiratory droplets and large particles during surgical mask shortages resulting from the declared public health emergency. Surgical masks that have been designed, evaluated, and validated consistent with the conditions set forth in FDA's EUA Authorization letter for these devices and that are not excluded from the scope and are not authorized under the EUA. |
| Mask, Oxygen, Low Concentration, Venturi | I 类 | BYF | 21 CFR 868.5600 | Anesthesiology | |
| Microelectronic Mask Or Chip Processing, Checking, And/Or Repair | 未分类 | RFG | — | Unknown | A laser intended to process, inspect, and/or repair microelectronic components in an industrial or commercial environment. |
| Surgical Mask With Antimicrobial/Antiviral Agent | II 类 | OUK | 21 CFR 878.4040 | General, Plastic Surgery | A single use, disposable surgical mask for occupational use to cover the nose and mouth of the wearer to protect from the transfer of microorganisms,body fluids and particulates and has an added antimicrobial and/or antiviral agent which kills specific pathogens under specified contact conditions. |
| Face Mask Within The Scope Of The Face Mask And Barrier Face Covering Enforcement Policy Or Face Mask Umbrella Eua | 未分类 | QKR | — | Unknown | Face mask is intended to be worn by general public or healthcare personnel and excludes air purifying respirators. The mask covers the user's nose and mouth and may or may not meet fluid barrier or filtration efficiency levels. The device is either subject to the Enforcement Policy for Face Masks and Barrier Face Coverings During the Coronavirus Disease (COVID-19) Public Health Emergency, available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/enforcement-policy-face-masks-and-barrier-face-coverings-during-coronavirus-disease-covid-19-public, provided that the device does not create undue risk by following the recommendations for this device type outlined in the guidance, or to the Face Mask Umbrella EUA, available at https://www.fda.gov/media/137121/download |
| Mask, Oxygen, Non-Rebreathing | I 类 | KGB | 21 CFR 868.5570 | Anesthesiology | |
| Mask, Ventilator, Non-Continuous, Reprocessed | II 类 | NMC | 21 CFR 868.5905 | Anesthesiology | Reprocessed mask for use with a non-continuous ventilator (CPAP, BiLevel pressure). 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). |
| Barrier Face Covering Within The Scope Of The Face Mask And Barrier Face Covering Enforcement Policy | 未分类 | QOZ | — | Unknown | A barrier face covering is a product worn on the face, specifically covering at least the wearers nose and mouth, with the primary purpose of providing source control and to provide a degree of particulate filtration to reduce the amount of inhaled particulate matter. The device is subject to the Enforcement Policy for Face Masks and Barrier Face Coverings During the Coronavirus Disease (COVID-19) Public Health Emergency, available https://www.fda.gov/regulatory-information/search-fda-guidance-documents/enforcement-policy-face-masks-and-barrier-face-coverings-during-coronavirus-disease-covid-19-public, provided that the device does not create undue risk by following the recommendations for this device type outlined in the guidance. |
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。