HaRi
Start Free→

FDA-listed sensor-based medical devices

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

244 devices · when each source was last refreshed

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

Device
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)
Physiotrace

Nimbleheart, Inc.

Registered with
  • US (FDA)
Polso Watch

Chronisense Medical, Ltd.

Registered with
  • US (FDA)
ProSomnus RPMO2 OSA Device (RPMO2 OSA)

Prosomnus Sleep Technologies, Inc.

Registered with
  • US (FDA)
Pulse Oximeter

Shenzhen Creative Industry Co., Ltd.

Registered with
  • US (FDA)
  • AU (TGA)
Pulse Oximeter ( PO2, PO2A, PO2B)

Shenzhen Viatom Technology Co Ltd

Registered with
  • US (FDA)
Radical-7 Pulse CO-Oximeter and Accessories, Rad-97 and Accessories

Masimo Corp.

Registered with
  • US (FDA)
REMI-AI Rapid Detection Module (REMI-AI RDM)

Epitel, Inc.

Registered with
  • US (FDA)
REMI Remote EEG Monitoring System

Epitel, Inc.

Registered with
  • US (FDA)
RhythmAnalytics

Biofourmis Singapore Pte., Ltd.

Registered with
  • US (FDA)
Rhythm Express Remote Cardiac Monitoring System (RX-1 mini)

Vivaquant, Inc.

Registered with
  • US (FDA)
RhythmStar System (SL)

Rhythmedix, LLC

Registered with
  • US (FDA)
Rune Labs Tremor Transducer System

Rune Labs, Inc.

Registered with
  • US (FDA)
RX-1 Sleep

Vivaquant, Inc. Dba Rhythm Express

Registered with
  • US (FDA)
Samsung ECG App v 1.3 (ECG)

Samsung Electronics Co., Ltd.

Registered with
  • US (FDA)
Samsung ECG Monitor Application with Irregular Heart Rhythm Notification

Samsung Electronics Co., Ltd.

Registered with
  • US (FDA)
SANSA HSAT

Huxley Medical

Registered with
  • US (FDA)
Scan Monitor

Withings

Registered with
  • US (FDA)
  • UK (MHRA)
SENSIMED TRIGGERFISH

SENSIMED SA

Registered with
  • US (FDA)
Serenity Piezo Sensor, Serenity Thermocouple Sensor

Neurotronics, LLC

Registered with
  • US (FDA)
Signos Glucose Monitoring System

Signos, Inc.

Registered with
  • US (FDA)
SimplECG

Nanowear, Inc.

Registered with
  • US (FDA)
Simplera System; Simplera Sync

Medtronic Minimed

Registered with
  • US (FDA)
  • UK (MHRA)
  • Canada (Health Canada)
SimpleSENSE

Nanowear, Inc.

Registered with
  • US (FDA)
SimpleSense-BP, SimpleSense-BP Software Application

Nanowear, Inc.

Registered with
  • US (FDA)
SimpleSENSE Platform

Nanowear, Inc.

Registered with
  • US (FDA)
Sine Monitoring Parkinson's Disease Tremor Dyskinesia Apple Watch ("SMPDTDAW")

Nordic Kinetics AB

Registered with
  • US (FDA)
Sleep Apnea Feature

Samsung Electronics Co., Ltd.

Registered with
  • US (FDA)
  • Canada (Health Canada)
  • AU (TGA)
  • EU (EUDAMED)
Sleep Apnea Notification Feature (SANF)

Apple, Inc.

Registered with
  • US (FDA)
Sleep Watch

AMBULATORY MONITORING, INC

Registered with
  • US (FDA)
SmartCardia 7L Platform

Smartcardia SA

Registered with
  • US (FDA)
SmartCardia 7L Platform (MCT)

Smartcardia SA

Registered with
  • US (FDA)
Somfit

Compumedics Limited

Registered with
  • US (FDA)
  • AU (TGA)
Somfit D

Compumedics Limited

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

Respironics, Inc.

Registered with
  • US (FDA)
SomniCheck

Brainmatterz, LLC

Registered with
  • US (FDA)
SOMNOtouch™ RESP

SOMNOMEDICS AG

Registered with
  • US (FDA)
  • UK (MHRA)
  • Canada (Health Canada)
  • EU (EUDAMED)
SPEAC System

Brain Sentinel, Inc.

Registered with
  • US (FDA)
Stelo Glucose Biosensor System

Dexcom, Inc.

Registered with
  • US (FDA)
Study Watch

Verily Life Sciences, LLC

Registered with
  • US (FDA)
Study Watch with Irregular Pulse Monitor

Verily Life Sciences, LLC

Registered with
  • US (FDA)
Study Watch with Irregular Pulse Monitor (Home), Study Watch with Irregular Pulse Monitor

Verily Life Sciences, LLC

Registered with
  • US (FDA)
Sunrise

Sunrise

Registered with
  • US (FDA)
Sunrise Sleep Disorder Diagnostic Aid

Sunrise

Registered with
  • US (FDA)
  • UK (MHRA)
  • AU (TGA)
  • EU (EUDAMED)
TempTraq

Blue Spark Technologies, Inc.

Registered with
  • US (FDA)
  • UK (MHRA)
  • EU (EUDAMED)
TempTraq TT-100

Blue Spark Technologies, Inc.

Registered with
  • US (FDA)
TipTraQ (TTQ001)

Pranaq Pte. , Ltd.

Registered with
  • US (FDA)
Triangle System

AliveCor, Inc.

Registered with
  • US (FDA)