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「patient monitor」检索 FDA 数据库。
共找到 251 条与「patient monitor」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 |
|---|---|---|---|---|---|---|
| K232962 | Patient Monitor (iX10, iX12, iX15) | Edan Instruments, Inc. | 2024-04-19 | Substantially Equivalent | MHX | Cardiovascular |
| K082280 | SURESIGNS VS2 VITAL SIGNS MONITOR, SURESIGNS VM1 PATIENT MONITOR, SURESIGNS VS3 CITAL SIGNS MONITOR | Philips Medical Systems North America Co. | 2008-10-08 | Substantially Equivalent | MHX | Cardiovascular |
| K201746 | Tempus Pro Patient Monitor | Remote Diagnostic Technologies Limited | 2020-09-18 | Substantially Equivalent | MHX | Cardiovascular |
| K161517 | Mortara Surveyor Patient Monitor | Mortara Instrument, Inc. | 2017-01-11 | Substantially Equivalent | MHX | Cardiovascular |
| K040651 | HOMMED SENTRY IIIB-F PATIENT MONITOR SYSTEM | Hommed, LLC | 2004-08-10 | Substantially Equivalent | DXN | Cardiovascular |
| K014025 | HOMMED SENTRY III PATIENT MONITOR SYSTEM WITH CARD READER | Hommed, LLC | 2002-04-09 | Substantially Equivalent | DQA | Cardiovascular |
| K113105 | TEMPUSIC PATIENT MONITOR | Remote Diagnostic Technologies , Ltd. | 2011-12-15 | Substantially Equivalent | MWI | Cardiovascular |
| K872291 | ESCORT PORTABLE PATIENT MONITOR | Medical Data Electronics | 1987-09-25 | Substantially Equivalent | DXO | Cardiovascular |
| K862462 | LIFESCOPE 6, OEC-6120 PORTABLE PATIENT MONITOR REC | Nihon Kohden America, Inc. | 1987-02-03 | Substantially Equivalent | BZQ | Anesthesiology |
| K842236 | PATIENT MONITOR 78354A | Hewlett-Packard Co. | 1985-01-18 | Substantially Equivalent | DRT | Cardiovascular |
| K882118 | MODEL 700 PATIENT MONITOR | Ivy Biomedical Systems, Inc. | 1988-08-02 | Substantially Equivalent | DRS | Cardiovascular |
| K081891 | FUKUDA DENSHI DYNASCOPE MODEL DS-7000/7000M PATIENT MONITOR | Fukuda Denshi USA, Inc. | 2008-08-29 | Substantially Equivalent | MHX | Cardiovascular |
| K880498 | RM-301 PATIENT MONITOR | Ppg Industries, Inc. | 1988-05-13 | Substantially Equivalent | DRT | Cardiovascular |
| K103737 | OMNI II PATIENT MONITOR | Infinium Medical | 2011-06-02 | Substantially Equivalent | MWI | Cardiovascular |
| K230626 | Portrait Central Viewer Application (Portrait CV A01), Portrait Core Services (Portrait CSS01), Portrait Clinical Alarming Unit (Portrait CAU01); Portrait Mobile Patient Monitor (Portrait HUB01), Portrait Sensor Battery (Portrait SBT01), Portrait Bedside Charger (Portrait BCH01); Portrait Wearable Pulse Oximetry Sensor (Portrait SpO2 P-SA01, Portrait SpO2 P-SP01, Portrait SpO2 P-W01 and Portrait SpO2 P-SE01); Portrait SpO2 Attachment Accessory Band (Portrait AAB01), Portrait | Ge Medical Systems Information Technologies, Inc. | 2023-08-11 | Substantially Equivalent | MWI | Cardiovascular |
| K832013 | LME PATIENT MONITOR SMS 151 | Litton Medical Electronics | 1983-10-31 | Substantially Equivalent | DPS | Cardiovascular |
| K844732 | KONTRON MINIMON 7132 PATIENT MONITOR | Kontron Instruments, Inc. | 1985-03-27 | Substantially Equivalent | DRT | Cardiovascular |
| K130056 | PATIENT MONITOR | Ld Technology, LLC | 2013-04-11 | Substantially Equivalent | MWI | Cardiovascular |
| K023871 | M3046A (M2/M3/M4) COMPACT PORTABLE PATIENT MONITOR AND MP60 & MP70 INTELLIVUE PATIENT MONITOR WITH PORTAL TECHNOLOGY | Philips Medical Systems | 2002-12-04 | Substantially Equivalent | MHX | Cardiovascular |
| K102040 | PATIENT MONITOR | Guangdong Biolight Meditech Co., Ltd. | 2010-09-24 | Substantially Equivalent | MHX | Cardiovascular |
| K043348 | MODIFICATION TO PM-8000 PATIENT MONITOR | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2005-01-06 | Substantially Equivalent | MWI | Cardiovascular |
| K992929 | DASH 3000 PATIENT MONITOR | General Electric Medical Systems Information Techn | 1999-11-26 | Substantially Equivalent | MHX | Cardiovascular |
| K260098 | ePM Series Patient Monitor (ePM 10/ePM 10A/ePM 10C/Guardian plus/ ePM 12/ePM 12A/ePM 12C / ePM 15/ePM 15A/ePM 15C /ePM 10M/ ePM 10MA/ ePM 10MC/ePM 12M/ ePM 12MA/ ePM 12MC/ePM 15M/ ePM 15MA/ ePM 15MC) | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2026-05-20 | Substantially Equivalent | MHX | Cardiovascular |
| K914092 | BSM-2100A CONFIGURED PATIENT MONITOR | Nihon Kohden America, Inc. | 1992-05-28 | Substantially Equivalent | DSI | Cardiovascular |
| K011784 | MODIFICATION TO ENVOY PATIENT MONITOR | Mennen Medical , Ltd. | 2001-08-16 | Substantially Equivalent | DSI | Cardiovascular |
| K100217 | LUCON M-SERIES PATIENT MONITOR, MODELS M20 AND M30 | Mediana Co., Ltd. | 2010-06-08 | Substantially Equivalent | MHX | Cardiovascular |
| K110334 | WALDO PATIENT MONITOR | Waldo Health | 2011-04-12 | Substantially Equivalent | DRG | Cardiovascular |
| K123048 | PATIENT MONITOR MODELS PM-2000A, PM-2000A+, PM-2000A PRO | Advanced Instrumentations, Inc. | 2013-01-11 | Substantially Equivalent | MHX | Cardiovascular |
| K884645 | PATIENT MONITOR RIGEL MODEL MULTICARE 429 | Rigel Medical Electronics, Inc. | 1989-02-02 | Substantially Equivalent | DRT | Cardiovascular |
| K871864 | PB240 PATIENT MONITOR/PULSE OXIMETER | Puritan Bennett Corp. | 1987-06-24 | Substantially Equivalent | DQA | Cardiovascular |
| K960272 | EAGLE 3000/3100 PATIENT MONITOR | Marquette Electronics, Inc. | 1996-10-02 | Substantially Equivalent | MLD | Cardiovascular |
| K831944 | PATIENT MONITOR #78832A | Hewlett-Packard Co. | 1983-10-19 | Substantially Equivalent | DRT | Cardiovascular |
| K831319 | PATIENT MONITOR #404 | Analogic Corp. | 1984-03-22 | Substantially Equivalent | KLK | Anesthesiology |
| K883069 | MINIMON 7134B PATIENT MONITOR | Kontron Instruments, Inc. | 1989-01-17 | Substantially Equivalent | DRT | Cardiovascular |
| K072346 | PM-7000 PATIENT MONITOR | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2007-11-29 | Substantially Equivalent | MHX | Cardiovascular |
| K896417 | KONTRON KOLORMON 7250 PATIENT MONITOR | Kontron Instruments, Inc. | 1989-12-12 | Substantially Equivalent | DPS | Cardiovascular |
| K843376 | ECG PATIENT MONITOR | Rigel Medical Electronics, Inc. | 1984-12-27 | Substantially Equivalent | DRT | Cardiovascular |
| K023798 | MODIFICATION TO ENVOY PATIENT MONITOR | Mennen Medical , Ltd. | 2002-12-03 | Substantially Equivalent | DSI | Cardiovascular |
| K150691 | Datalys Multi-Parameter Patient Monitor | Lutech Industries, Inc. | 2015-05-15 | Substantially Equivalent | MWI | Cardiovascular |
| K033410 | TEMPUS 2000 PATIENT MONITOR, MODEL 00-0002 | Remote Diagnostic Technologies , Ltd. | 2004-03-05 | Substantially Equivalent | DXH | Cardiovascular |
| K053234 | PM-9000 EXPRESS PATIENT MONITOR | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2006-05-04 | Substantially Equivalent | MWI | Cardiovascular |
| K151681 | IntelliVue Patient Monitor | Philips Medizin Systeme Boeblingen GmbH | 2015-07-17 | Substantially Equivalent | DSI | Cardiovascular |
| K251702 | IntelliVue Patient Monitor MX750; IntelliVue Patient Monitor MX850; IntelliVue 4-Slot Module Rack FMX-4 (866471 866470 866468 ) | Philips Medizin Systeme Böblingen GmbH | 2025-11-10 | Substantially Equivalent | MHX | Cardiovascular |
| K123556 | MORTARA SURVEYOR PATIENT MONITOR | Mortara Instrument, Inc. | 2013-03-22 | Substantially Equivalent | MHX | Cardiovascular |
| K850155 | ECG PATIENT MONITOR 302 | Rigel Medical Electronics, Inc. | 1985-03-01 | Substantially Equivalent | DRT | Cardiovascular |
| K955642 | NELLCOR SYMPHONY N-3000 PATIENT MONITOR W/SP02 & ECG/N-3200 DISPLAY/PRINTER | Nellcor Puritan Bennett, Inc. | 1996-07-02 | Substantially Equivalent | DPS | Cardiovascular |
| K101692 | PATIENT MONITOR | Contec Medical System Co., Ltd. | 2011-06-28 | Substantially Equivalent | MHX | Cardiovascular |
| K000563 | MODIFICATION TO ENVOY PATIENT MONITOR | Mennen Medical , Ltd. | 2000-05-17 | Substantially Equivalent | MHX | Cardiovascular |
| K024245 | ENVOY PATIENT MONITOR | Mennen Medical , Ltd. | 2004-05-10 | Substantially Equivalent | OMC | Neurology |
| K150310 | IntelliVue Patient Monitor | Philips Medizin Systeme Boeblingen GmbH | 2015-05-13 | Substantially Equivalent | DSI | 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。