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「mask」检索 FDA 数据库。
共找到 972 条与「mask」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 |
|---|---|---|---|---|---|---|
| K212371 | F&P Evora Full Face Mask | Fisher & Paykel Healthcare, Ltd. | 2022-03-18 | Substantially Equivalent | BZD | Anesthesiology |
| K180847 | Neutrogena Light Therapy Acne Mask+ | Johnson & Johnson Consumer, Inc. | 2018-06-19 | Substantially Equivalent | OLP | General, Plastic Surgery |
| K242068 | LED Light Therapy Mask (RT01) | Ningbo Dechang Electrical Machinery Made Co.,Ltd | 2025-04-04 | Substantially Equivalent | OLP | General, Plastic Surgery |
| K926118 | LIFE TRACE(R) BILIRUBIN MASK | Graphic Controls Corp. | 1993-03-15 | Substantially Equivalent | FOK | General Hospital |
| K254079 | LED Light Therapy Mask (Models: T2, RLD10) | Shenzhen Desida Technology Co., Ltd. | 2026-03-16 | Substantially Equivalent | OHS | General, Plastic Surgery |
| K013306 | MINIME NASAL MASK, MODEL P/N 50220 | Sleepnet Corporation | 2001-11-02 | Substantially Equivalent | BZD | Anesthesiology |
| K862791 | MP-30XM-IE FACE MASK AND FILTER KIT | Medipart Jerry Alexander | 1986-08-01 | Substantially Equivalent | IYT | Radiology |
| K070467 | HEALTH MASK | Polar Wrap, LLC | 2007-04-17 | Substantially Equivalent | OBN | Anesthesiology |
| K080209 | FISHER AND PAYKEL HEALTHCARE ZEST NASAL MASK | Fisher & Paykel Healthcare, Ltd. | 2008-09-12 | Substantially Equivalent | BZD | Anesthesiology |
| K213358 | Surgical Mask | Shenzhen Safesecure Medical Infection Control Tech Co. , Ltd. | 2022-03-04 | Substantially Equivalent | FXX | General, Plastic Surgery |
| K142554 | Revolution Full Face Mask | Respironics, Inc. | 2015-01-09 | Substantially Equivalent | BZD | Anesthesiology |
| K911907 | FLUIDSHIELD CONE CLASSIC II SURG MASK W/SPLASH VIS | Tecnol New Jersey Wound Care, Inc. | 1991-07-08 | Substantially Equivalent | FXX | General, Plastic Surgery |
| K252941 | HALYARD* Adult Face Mask with SO SOFT* Lining and SO SOFT* Earloops | O&M Halyard, Inc. | 2025-12-11 | Substantially Equivalent | FXX | General, Plastic Surgery |
| K262932 | AMIRO Spectra 10-in-1 LED Light Therapy Mask (L3) | Shenzhen Accompany Technology Co., Ltd. | 2026-10-19 | Substantially Equivalent | OHS | General, Plastic Surgery |
| K232806 | HALYARD* FLUIDSHIELD* 1 Procedure Mask with So Soft Lining and So Soft Earloops (25867); HALYARD* Level 1 Procedure Mask (48388) | Owens & Minor (O&M) Halyard, Inc. | 2024-06-07 | Substantially Equivalent | FXX | General, Plastic Surgery |
| K201625 | Disposable Medical Surgical Mask | Tianjin Saiyuan Technology Co., Ltd. | 2021-01-12 | Substantially Equivalent | FXX | General, Plastic Surgery |
| K233723 | Medical surgical mask | Guangdong Kingfa Sci. & Tech.Co., Ltd. | 2024-07-29 | Substantially Equivalent | FXX | General, Plastic Surgery |
| K021539 | DERMASSIST FLUID RESISTANT SURGICAL MASK (ORANGE) AND PROCEDURE MASK WITH TIE-ON AND WITH EARLOOPS | Creative Contract (M) Sdn Bhd | 2003-03-05 | Substantially Equivalent | FXX | General, Plastic Surgery |
| K221775 | LED Light Therapy Mask (model: MK-78, MK-04, MK66-H, MK66R-B, EL00003) | Light Tree Ventures Europe B.V. | 2022-12-20 | Substantially Equivalent | OHS | General, Plastic Surgery |
| K924217 | LSPI DISPOSABLE BAG MASK RESUSCITATOR/MODIFIED | Life Support Products, Inc. | 1992-09-17 | Substantially Equivalent | BTM | Anesthesiology |
| K841240 | DISPOSABLE ANESTHESIA MASK | Hospitak, Inc. | 1984-04-05 | Substantially Equivalent | BSJ | Anesthesiology |
| K203591 | Single-use Medical Face Mask | Conod Medical Co., Limited | 2021-07-02 | Substantially Equivalent | FXX | General, Plastic Surgery |
| K211462 | Disposable Ear-loop Medical Face Mask, Disposable Tie-On Medical Face Mask | Xiantao S&J Protective Products Co., Ltd. | 2021-08-19 | Substantially Equivalent | FXX | General, Plastic Surgery |
| K951491 | DALE TRACHEOSTOMY TUBE HOLDER WITH TRACH MASK ATTACHMENT TABS | Dale Medical Products, Inc. | 1995-04-24 | Substantially Equivalent | CBH | Anesthesiology |
| K210622 | Single-Use Medical Face Mask | Jiangxi Hongda Medical Equipment Group Co., Ltd. | 2021-10-08 | Substantially Equivalent | FXX | General, Plastic Surgery |
| K955556 | FLUID RESISTANT MASK | American Threshold Healthcare | 1996-04-25 | Substantially Equivalent | FXX | General, Plastic Surgery |
| K230395 | Durio Surgical Face Mask, Models 501 (3-ply, blue) and 545 (4-ply,blue) | Durio Ppe Sdn Bhd | 2023-07-17 | Substantially Equivalent | FXX | General, Plastic Surgery |
| K213617 | Surgical Face Mask | Megasoft (China) Co., Ltd. | 2022-02-11 | Substantially Equivalent | FXX | General, Plastic Surgery |
| K060067 | MASKMEDIC CONCEPT NASAL MASK | Maskmedic | 2006-07-14 | Substantially Equivalent | BZD | Anesthesiology |
| K965043 | 3M 1830 FLUID BLOCK ANTI-FOG TIE-ON SURGICAL MASK AND 3M 1830FS FLUID BLOCK ANTI-FOG TIE-ON SURGICAL MASK WITH FACE SHIE | Minnesota Mining and Mfg. Co. | 1997-03-10 | Substantially Equivalent | FXX | General, Plastic Surgery |
| K904344 | SLEEPER MASK SYSTEM | Devilbiss Health Care, Inc. | 1991-05-01 | Substantially Equivalent | BZD | Anesthesiology |
| K251847 | Sleepnet Arie Full Face Vented Mask; Sleepnet Arie Nasal Vented Mask | Sleepnet Corporation | 2026-01-15 | Substantially Equivalent | BZD | Anesthesiology |
| K212344 | Surgical Mask | Xiantao Dingcheng Non-Woven Product Co., Ltd. | 2021-11-16 | Substantially Equivalent | FXX | General, Plastic Surgery |
| K862783 | MP-XMV DISPOSABLE FACE MASK | Medipart Jerry Alexander | 1986-08-01 | Substantially Equivalent | BSJ | Anesthesiology |
| K112126 | GENUINE FIRST AID CPR MASK | Genuine First Aid, LLC | 2011-12-01 | Substantially Equivalent | CBP | Anesthesiology |
| K200576 | ClearMask Transparent Surgical Face Mask | Clearmask, LLC | 2020-04-06 | Substantially Equivalent | FXX | General, Plastic Surgery |
| K803185 | NON-CONDUCTIVE ANESTHESIA FACE MASK | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1981-01-05 | Substantially Equivalent | BSJ | Anesthesiology |
| K213806 | Disposable Medical Face Mask | Xiantao Zhibo Nonwoven Products Co., Ltd. | 2022-03-12 | Substantially Equivalent | FXX | General, Plastic Surgery |
| K202903 | Surgical Face Mask | Rizhao Sanqi Medical & Health Articles Co., Ltd. | 2022-03-24 | Substantially Equivalent | FXX | General, Plastic Surgery |
| K913558 | RELIABLE CONE STYLE FACE MASK | Anago, Inc. | 1991-11-07 | Substantially Equivalent | FXX | General, Plastic Surgery |
| K163329 | Pulsaderm Wrinkle Mask 28, Pulsaderm Wrinkle Mask 72 | Pulsaderm, LLC | 2017-04-14 | Substantially Equivalent | OHS | General, Plastic Surgery |
| K210643 | Disposable Surgical Face Mask | Shandong Zhushi Pharmaceutical Group Co., Ltd. | 2021-08-04 | Substantially Equivalent | FXX | General, Plastic Surgery |
| K200089 | F&P Evora Nasal Mask Nasal A Model (Small, Medium, Large, Wide), F&P Evora Nasal Mask Nasal Fit Pack/ SML (Small/Medium/Large) A Model, F&P Evora Nasal Mask Nasal Sleep Lab (Small, Medium, Large, Wide), F&P Evora Nasal Mask Nasal Fit Pack / SML (Small/Medium/Large) Sleep Lab Model | Fisher & Paykel Healthcare, Ltd. | 2020-06-02 | Substantially Equivalent | BZD | Anesthesiology |
| K203528 | KNH Surgical Face Mask | Knh Surgical Face Mask | 2022-11-16 | Substantially Equivalent | FXX | General, Plastic Surgery |
| K211772 | PMW01 Procedure Mask Level 1 | Defender Safety, Inc. | 2021-12-06 | Substantially Equivalent | FXX | General, Plastic Surgery |
| K991648 | REUSABLE CONTOUR II NASAL MASK | Respironics, Inc. | 1999-05-28 | Substantially Equivalent | BZD | Anesthesiology |
| K913164 | NON REBREATHING MASK | Specialty Packaging Producs, Inc. | 1992-01-15 | Substantially Equivalent | KGB | Anesthesiology |
| K102317 | IQ VENTILATION NASAL MASK | Sleepnet Corporation | 2011-05-17 | Substantially Equivalent | BZD | Anesthesiology |
| K212375 | Disposable Medical Surgical Mask | Jiangxi Bestgrand Health Technology Co., Ltd. | 2022-01-04 | Substantially Equivalent | FXX | General, Plastic Surgery |
| K895077 | SURGICAL MASK/DENTAL MASK | Ashton Medical Products, Inc. | 1989-11-03 | Substantially Equivalent | FXX | General, Plastic Surgery |
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。