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FDA-listed sensor-based medical devices

Devices the FDA identifies as sensor-based, with the regulators each one is registered with.

236 devices · when each source was last refreshed

Registers: US (FDA) · UK (MHRA) · CA (Health Canada) · AU (TGA) · EU (EUDAMED)

Device
ActiGraph CentrePoint Insight Watch

Actigraph, LLC

Registered with
  • US (FDA)
ActiGraph LEAP activity monitor (ActiGraph LEAP)

Actigraph, LLC

Registered with
  • US (FDA)
AcuPebble Ox (200)

Acurable Limited

Registered with
  • US (FDA)
AcuPebble SA

Acurable Limited

Registered with
  • US (FDA)
AeviceMD

Aevice Health Pte. , Ltd.

Registered with
  • US (FDA)
  • AU (TGA)
AGE Automatic Wrist Blood Pressure Monitor

Dongguan Ageless Health Industrial Co., Ltd.

Registered with
  • US (FDA)
AGE Automatic Wrist Blood Pressure Monitor

Dongguan E-Test Technology Co., Ltd.

Registered with
  • US (FDA)
Alio

Alio, Inc.

Registered with
  • US (FDA)
Alio Medical Remote Monitoring System

Graftworx, Inc. Dba Alio

Registered with
  • US (FDA)
ANNE Chest

Sibel Health Inc.

Registered with
  • US (FDA)
ANNE Limb

Sibel Health Inc.

Registered with
  • US (FDA)
ANNE One

Sibel Health Inc.

Registered with
  • US (FDA)
ANNE Sleep

SIBEL SAU

Registered with
  • US (FDA)
ANNE View, Central Hub

Sibel Health Inc.

Registered with
  • US (FDA)
Apnea Risk Evaluation System (ARES), Model 620

WATERMARK MEDICAL

Registered with
  • US (FDA)
Atrial Fibrillation History Feature

Apple, Inc.

Registered with
  • US (FDA)
  • UK (MHRA)
  • EU (EUDAMED)
Aulisa Infant Oximeter Module (2nd Gen.) (GA-OM0018)

Taiwan Aulisa Medical Devices Technologies, Inc.

Registered with
  • US (FDA)
Aulisa Oximeter Module (2nd Gen.) (GA-OM0007, GA-OM0008)

Taiwan Aulisa Medical Devices Technologies, Inc.

Registered with
  • US (FDA)
BabySat 3

Owlet Babycare, Inc.

Registered with
  • US (FDA)
BB-613-BPM

Biobeat Technologies , Ltd.

Registered with
  • US (FDA)
BB-613WP

Biobeat Technologies , Ltd.

Registered with
  • US (FDA)
Belun Ring BLR-100X

Belun Technology Company Limited

Registered with
  • US (FDA)
Belun Sleep System BLS-100

Belun Technology Company Limited

Registered with
  • US (FDA)
Bigfoot Unity Diabetes Management System

Bigfoot Biomedical, Inc.

Registered with
  • US (FDA)
BioButton System

Biointellisense, Inc.

Registered with
  • US (FDA)
BioButton System

Biolntellisense, Inc.

Registered with
  • US (FDA)
Biofourmis Everion+ (G2)

Biofourmis Singapore Pte., Ltd.

Registered with
  • US (FDA)
Biolinq Shine Autonomous Time-in-Range Microsensor

Biolinq Incorporated

Registered with
  • US (FDA)
BioStamp nPoint

Mc10, Inc.

Registered with
  • US (FDA)
BioSticker System

Biointellisense, Inc.

Registered with
  • US (FDA)
Biovitals Analytics Engine

Biofourmis Singapore Pte., Ltd.

Registered with
  • US (FDA)
BIS STANDARD SENSOR,1-CHANNEL (3 ELECTRODES); BIS PEDI SENSOR,1-CHANNEL,3 ELECTRODES; BIS QUATRO SENSOR; BIS PEDI-XP SENSOR,2-CHANNEL (4 ELECTRODES); BIS EXTEND SENSOR; BIS BILATERAL SENSOR,4-CHANNEL (6 ELECRODES); BIS INSIGHT SENSOR,CVI-ENABLED,2-CHANNEL (4 ELECTRODES)

Covidien

Registered with
  • US (FDA)
BodyGuardian Remote Monitoring System (BGRMS v3.0)

BOSTON SCIENTIFIC CARDIAC DIAGNOSTIC TECHNOLOGIES, INC.

Registered with
  • US (FDA)
Body Temperature Software (BTS)

Fitbit, Inc.

Registered with
  • US (FDA)
  • Canada (Health Canada)
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

Amzetta Technologies Private Limited

Registered with
  • US (FDA)
BresoDX1

BRESOTEC INCORPORATED

Registered with
  • US (FDA)
CARDIOSKIN

BIOSERENITY SAS

Registered with
  • US (FDA)
CardioTag™

Cardiosense, Inc.

Registered with
  • US (FDA)
Cerebra Sleep System

CEREBRA MEDICAL

Registered with
  • US (FDA)
Ceribell Instant EEG Headband

Ceribell, Inc.

Registered with
  • US (FDA)
Checkme O2 Pulse Oximeter

Shenzhen Viatom Technology Co Ltd

Registered with
  • US (FDA)
circul™ pro Ring

Bodimetrics, LLC

Registered with
  • US (FDA)
Companion

Lgch, Inc.

Registered with
  • US (FDA)
Corsano CardioWatch 287-2 System

Corsano Health BV

Registered with
  • US (FDA)
CSF-4 (CSF-4)

CardiacSense Ltd

Registered with
  • US (FDA)
Current Health Monitoring System Gen 2 (G2)

Current Health , Ltd.

Registered with
  • US (FDA)
Current Health System

Current Health , Ltd.

Registered with
  • US (FDA)
  • UK (MHRA)
DeepRESP

Nox Medical Ehf

Registered with
  • US (FDA)
DeepRhythmAI

Medicalgorithmics SP Z.O.O.

Registered with
  • US (FDA)
  • UK (MHRA)
  • Canada (Health Canada)
  • EU (EUDAMED)
Dexcom G6 Continuous Glucose Monitoring (CGM) System

Dexcom, Inc.

Registered with
  • US (FDA)