MWI
M2376A DEVICELINK SYSTEM
- Advisory panel
- Cardiovascular
- Total cleared
- 304
Adverse events under product code MWI
product code MWI- Death
- 16
- Malfunction
- 963
- Total
- 979
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recent clearances under product code MWI
1–100 of 304- K250135 — WAVE Clinical Platform (2.0.000)
- K241766 — QMAPP® (Hemo, Hemo Lite, PCM, GO, Hybrid)
- K242737 — Empatica Health Monitoring Platform; EmbracePlus; Empatica Care; Care Portal
- K241958 — WARD-CSS (v1.2.x)
- K243146 — iCare APP
- K241411 — Welch Allyn Connex® Spot Monitor; 901058 Vital Signs Monitor Core (CSM)
- K243216 — Sensinel Cardiopulmonary Management (CPM) System (ADCP1100)
- K233446 — AMC Health CareConsole
- K240236 — Happy Ring Health Monitoring System
- K233354 — WVSM Pro (Series) (500-0030-XX)
- K232111 — NeoBeat, NeoBeat Mini
- K233810 — Portrait VSM
- K233133 — Talis EMR with Talis +ACG (Talis EMR with +ACG)
- K234130 — Portrait Mobile Monitoring Solution consists of: Portrait Central Viewer Application (Portrait CVAXB) Portrait Core Services (Portrait CSSXB) Portrait Clinical Alarming Unit (Portrait CAU01) Portrait Mobile Patient Monitor Hardware (Portrait HUBXB) Portrait Mobile Patient Monitor Software (Portrait HSWXB) Portrait Wearable Pulse Oximetry Sensor (Portrait SpO2 P-SA01) Portrait Wearable Pulse Oximetry Sensor (Portrait SpO2 P-SP01) Portrait Wearable Pulse O
- K233038 — Vital Signs monitor, Model: iM3s, iM3As, iM3Bs, iHM3s
- K231086 — CPM System
- K230457 — Empatica Health Monitoring Platform; EmbracePlus; Empatica Care; Care Portal
- K230881 — Change Healthcare Cardiology Hemodynamics
- 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
- K220117 — ARC Intensive Care Information System (ARC System)
- K230214 — Huma RPM (RPM)
- K222330 — The Heart Seat
- K212161 — Radical-7 Pulse CO-Oximeter and Accessories, Rad-97 and Accessories
- K221267 — VS 8 Vital Signs Monitor, VS 8A Vital Signs Monitor, VS 9 Vital Signs Monitor
- K221113 — Accutorr 3 Vital Signs Monitor, Rosebud Vital Signs Monitor
- K212473 — Welch Allyn Connex Central Station
- K212975 — MedWand
- K213335 — Capsule Surveillance System
- K211754 — Vital Signs Monitor
- K210204 — Capsule Vitals Plus Patient Monitoring System
- K211475 — Vital Signs Monitors
- K212227 — Philips MR Patient Care Portal
- K210086 — Vitals360 Multi-Vitals Mobile Monitor
- K202375 — ZOLL Propaq M
- K200160 — 740 SafeSAT
- K201635 — MouthLab Vital Signs Monitoring System
- K202892 — Vital Signs Monitor:iM3s, iM3As, iM3Bs, iHM3s
- K202306 — T3 Platform software
- K193626 — Masimo Rad-97 Pulse CO-Oximeter and Accessories
- K200856 — SmartLinx Vitals Plus Patient Monitoring System
- K200141 — Oxi-W System
- K191882 — Masimo Centroid System
- K193242 — Masimo Rad-97 Pulse CO-Oximeter and Accessories, Masimo Radical-7 Pulse CO-Oximeter and Accessories, Masimo Radius-7 Pulse CO-Oximeter and Accessories
- K191989 — WVSM (Wireless Vital Signs Monitor) RWC + miniCap
- K192004 — Eko Analysis Software
- K191059 — Masimo Rad-97 and Accessories
- K190273 — T3 Platform software
- K183687 — LifeWindow LW8 Lite
- K183370 — PeraMobile and PeraWatch
- K182401 — B.O.L.T Base Unit, B.O.L.T Non-Invasive Blood Pressure (NIBP) Cuff, B.O.L.T Infared Radiation Energy Technology(IRT) Thermometer probe, B.O.L.T Pulse Oximeter(SPO2) probe, B.O.L.T Gluchobin Blood Glucose, Total Cholesterol and Hemoglobin meter
- K190090 — DynoSense Vital Sign Measuring System
- K190468 — Nihon Kohden SVM-7200 Series Vital Signs Monitor
- K183697 — Masimo Rad-97 and Accessories
- K183634 — Stasis Monitoring System
- K183638 — SmartLinx Vitals Plus Patient Monitoring System
- K181541 — Connect App for iHealth Next, iHealth React Native SDK, iHealth React Native Library SDK, iHealth Library SDK, iHealth Native SDK
- K181919 — Patient Monitor
- K180903 — 3880 MRI Patient Monitoring System
- K182821 — Accutorr 7/VS-900/VS-900c Vital Signs Monitor
- K172965 — Handheld VitalSigns Monitoring System
- K182900 — 3880 MRI Patient Monitoring System
- K183116 — Unity Network ID
- K182226 — AirStrip RPM InvisionHeart Adapter
- K181311 — Philips Hemodynamic Application R1.0
- K180734 — SmartLinx Vitals Plus Patient Monitoring System
- K172221 — VTRUST Vital Signs Monitor, Model: TD-2300; FORA Vital Signs Monitor, Model: VSM100
- K172147 — STAR 65
- K172959 — PeraServer and PeraTrend
- K171361 — BETTERCARE PLATFORM - ADVANCED WEB CLIENT
- K171056 — WAVE Clinical Platform
- K171121 — Masimo Root Monitoring System and Accessories
- K172200 — 3880 MRI Patient Monitoring System
- K171751 — SmartLinx Vitals Plus NIBP Module, SmartLinx Vitals Plus License for Spot Monitoring Mode, SmartLinx Vitals Plus Alarm Hub, SmartLinx Vitals Plus License for Advanced Monitoring Mode, Covidien FILAC 3000 - Temperature Module
- K170538 — RVS-100 Vital Signs Monitor
- K170168 — Masimo Rad-97 and Accessories
- K170047 — All-in-One Health Monitor, PC-303
- K170032 — QMAPP Amplifier; QMAPP Hemodynamic Monitoring System; QMAPP PCM; QMAPP GO; QMAPP EP
- K170712 — Accutorr 7/VS-900 Vital Signs Monitor
- K170798 — Dictum Health
- K160899 — CoVa Monitoring System 2
- K163065 — T3 Software
- K170199 — Unity Network ID
- K162234 — Truscope Ultra Patient Monitor
- K161909 — IQvitals Zone
- K160718 — Vital Sync Informatics Manager & Virtual Patient Monitoring Platform
- K151839 — AMC Health VitalCaregiving System
- K160956 — LD-Oxi system
- K153739 — MRI Patient Monitor TeslaDUO
- K153225 — Masimo Root Monitoring System and Accessories
- K153079 — Axeo 3 Patient Monitor
- K153335 — AlertWatch: OR
- K153135 — VITAL SIGNS MONITOR
- K151512 — Star 60
- K151644 — Masimo Root Vital Signs Monitoring System and Accessories
- K152645 — Dictum Health
- K152330 — Expression MR400 MRI Patient Monitoring System
- K152341 — ViSi Mobile Monitoring System
- K150869 — Checkme Pro Health Monitor
- K151715 — T3 Software
- K152124 — Tempus IC2
Data sourced from openFDA. This site is unofficial and independent of the FDA.