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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
Full Automatic (NIBP) Blood Pressure Monitor-HL158TB

HEALTH & LIFE CO., LTD.

Registered with
  • US (FDA)
Full Automatic (NIBP) Blood Pressure Monitor-HL158UB

HEALTH & LIFE CO., LTD.

Registered with
  • US (FDA)
G0 Blood Pressure Monitoring System (G0)

Aktiia SA

Registered with
  • US (FDA)
Garmin ECG App

Garmin International, Inc.

Registered with
  • US (FDA)
  • UK (MHRA)
  • Canada (Health Canada)
  • AU (TGA)
  • EU (EUDAMED)
Guardian Angel Rx GA 1001 Digital Vital Sign Monitoring System

Taiwan Aulisa Medical Devices Technologies, Inc.

Registered with
  • US (FDA)
Guardian Angel Rx GA2000 Digital Vital Sign Monitoring System

Taiwan Aulisa Medical Devices Technologies, Inc.

Registered with
  • US (FDA)
Guardian Angel Rx GA2001 Digital Vital Sign Monitoring System

Taiwan Aulisa Medical Devices Technologies, Inc.

Registered with
  • US (FDA)
Happy Health Home Sleep Test

Happy Health, Inc.

Registered with
  • US (FDA)
Happy Ring Health Monitoring System

Happy Health, Inc.

Registered with
  • US (FDA)
Hearing Aid Feature (HAF)

Apple, Inc.

Registered with
  • US (FDA)
HemoSphere Nano Monitor (HSNANO1)

Edwards Lifesciences, LLC

Registered with
  • US (FDA)
Hexoskin Medical System (7100-00016)

Carre Technologies, Inc.

Registered with
  • US (FDA)
HomeSleepTest (HST, HST REM+)

SOMNOMEDICS AG

Registered with
  • US (FDA)
HRVWatch-Mini Wrist Monitor

Taiwan Scientific Corporation

Registered with
  • US (FDA)
Huxley SANSA Home Sleep Apnea Test (1000-00)

Huxley Medical

Registered with
  • US (FDA)
Hypertension Notification Feature (HTNF)

Apple, Inc.

Registered with
  • US (FDA)
  • AU (TGA)
IRNF App

Apple, Inc.

Registered with
  • US (FDA)
  • UK (MHRA)
Irregular Rhythm Notification Feature

Apple, Inc.

Registered with
  • US (FDA)
  • Canada (Health Canada)
  • AU (TGA)
  • EU (EUDAMED)
Irregular Rhythm Notification Feature (IRNF)

Apple, Inc.

Registered with
  • US (FDA)
KardiaMobile 6L

AliveCor, Inc.

Registered with
  • US (FDA)
  • UK (MHRA)
  • Canada (Health Canada)
  • AU (TGA)
KardiaMobile Card

AliveCor, Inc.

Registered with
  • US (FDA)
  • Canada (Health Canada)
KardiaMobile, KardiaStation

AliveCor, Inc.

Registered with
  • US (FDA)
Libre Rio Continuous Glucose Monitoring System

Abbott Diabetes Care, Inc.

Registered with
  • US (FDA)
Lingo Glucose System

Abbott GmbH

Registered with
  • US (FDA)
Loss of Pulse Detection

Fitbit, Inc.

Registered with
  • US (FDA)
  • UK (MHRA)
  • Canada (Health Canada)
  • EU (EUDAMED)
Masimo Stork

Masimo Corp.

Registered with
  • US (FDA)
Masimo W1

Masimo Corp.

Registered with
  • US (FDA)
  • UK (MHRA)
  • Canada (Health Canada)
  • AU (TGA)
MATRx plus

ZEPHYR SLEEP TECHNOLOGIES

Registered with
  • US (FDA)
MEMO Patch M (MPT-E08R-UNC01)

HUINNO Co., Ltd.

Registered with
  • US (FDA)
MiCor A100 Wearable ECG Recorder

Mitac International Corp.

Registered with
  • US (FDA)
Nautilus BrainPulse 1000

Jan Medical, Inc.

Registered with
  • US (FDA)
Nelli (Version 7.11)

Neuro Event Labs Oy

Registered with
  • US (FDA)
Neon EEG

Incereb, Ltd.

Registered with
  • US (FDA)
Neu Platform

Neuhealth Digital , Ltd.

Registered with
  • US (FDA)
NeuroRPM

New Touch Digital, Inc.

Registered with
  • US (FDA)
New Wave System

Zeto, Inc.

Registered with
  • US (FDA)
NightOwl

Ectosense NV

Registered with
  • US (FDA)
  • AU (TGA)
NightWatch+ US

Livassured BV

Registered with
  • US (FDA)
NomadAir PMU810

Neurotronics, LLC

Registered with
  • US (FDA)
Nox Sleep System

Nox Medical

Registered with
  • US (FDA)
Omron Model BP7900 Blood Pressure Monitor + EKG

Omron Healthcare, Inc.

Registered with
  • US (FDA)
Onera SleepMap (SLEEPMAP)

Onera B.V.

Registered with
  • US (FDA)
Onera Sleep Test System (Onera STS)

Onera B.V.

Registered with
  • US (FDA)
Onera STS 2 (ONERA STS 2)

Onera B.V.

Registered with
  • US (FDA)
OxiWear

Oxiwear, Inc.

Registered with
  • US (FDA)
Parky App

H2o Bilisim Yazilim

Registered with
  • US (FDA)
Pediarity™

Hinlab, Inc.

Registered with
  • US (FDA)
Perin Health System (PHD80060-2)

Perin Health Devices, LLC

Registered with
  • US (FDA)
PERSONAL KINETIGRAPH (PKG) SYSTEM

Gkc Manufacturing Pty, Ltd.

Registered with
  • US (FDA)
Personal Kinetigraph (PKG) System Gen 2 Plus

Gkc Manufacturing Pty, Ltd.

Registered with
  • US (FDA)