MedikalDevice

Device directory

Connected and AI-enabled medical devices

63 independent profiles, grouped by clinical use. Prices in USD.

Blood pressure

Blood pressure Beurer BM 95 Blood Pressure Monitor With ECG Beurer BM 95 Blood Pressure Monitor With ECG: FDA status not confirmed. An oscillometric upper-arm blood pressure monitor with a detachable stick for… US$ 220 Blood pressure iHealth Track Blood Pressure Monitor (KN-550BT) iHealth Track Blood Pressure Monitor (KN-550BT): FDA 510(k) cleared (K160014). An automatic upper-arm oscillometric blood pressure monitor that measures… US$ 119 Blood pressure Omron HeartGuide Wearable BP Monitor Omron HeartGuide Wearable BP Monitor: FDA 510(k) cleared (K182481). A wristwatch-style home blood pressure monitor with an inflatable cuff built into the… US$ 948

Dermatology

Dermatology DermLite DL4 / DL5 Dermatoscope DermLite DL4 / DL5 Dermatoscope: exempt from FDA 510(k). Handheld battery-powered dermatoscopes (10x magnification) with polarized and non-polarized LED… US$ 1,895 Dermatology SkinVision Skin Cancer Risk App SkinVision Skin Cancer Risk App: not FDA-cleared. A smartphone app (software, not a hardware scanner) that analyzes a photo of a skin spot and gives a… US$ 7

ECG & cardiac

ECG & cardiac AliveCor KardiaMobile 6L ECG AliveCor KardiaMobile 6L ECG: FDA 510(k) cleared (K210753). Personal 6-lead ECG device with three electrodes: two thumbs on top and one electrode on the… US$ 179 ECG & cardiac Bionet Cardio7 Touch Screen ECG System Bionet Cardio7 Touch Screen ECG System: FDA 510(k) cleared (K113306). A 12-lead, 12-channel resting electrocardiograph with a 7-inch color touch screen… US$ 2,250 ECG & cardiac Edan SE-1515 PC-Based ECG System Edan SE-1515 PC-Based ECG System: FDA 510(k) cleared (K152427). A PC-based electrocardiograph: an acquisition box or wireless transmitter captures ECG… US$ 3,930 ECG & cardiac EMAY 6L Portable EKG Monitor EMAY 6L Portable EKG Monitor: FDA status not confirmed. A handheld ECG recorder that records up to 6 leads (I, II, III, aVR, aVL, aVF) or single-lead ECG… US$ 169 ECG & cardiac EMAY Portable ECG Monitor EMAY Portable ECG Monitor: FDA status not confirmed. Handheld single-lead ECG recorder for home use that records a 30-second ECG through finger electrodes… US$ 109 ECG & cardiac Lepu-Creative PC-80B Easy ECG Monitor Lepu-Creative PC-80B Easy ECG Monitor: FDA status not confirmed. A handheld single-channel ECG recorder that captures ECG via built-in electrodes (palm… US$ 239 ECG & cardiac Welch Allyn ELI 280 Resting ECG (formerly Mortara) Welch Allyn ELI 280 Resting ECG (formerly Mortara): FDA 510(k) cleared (K122073). A 12-lead resting electrocardiograph (ECG cart) for acquiring, printing… US$ 6,990 ECG & cardiac Wellue PulseBit EX Personal ECG Monitor Wellue PulseBit EX Personal ECG Monitor: not FDA-cleared. A palm-sized single-lead ECG recorder that captures short ECG strips via its electrodes or a… US$ 203

Eye & retina

Eye & retina D-EYE Digital Ophthalmoscope D-EYE Digital Ophthalmoscope: exempt from FDA 510(k). A smartphone attachment that uses the phone's camera and light source with cross-polarization optics… US$ 540 Eye & retina EyeQue Personal Vision Tracker EyeQue Personal Vision Tracker: exempt from FDA 510(k). Consumer self-test kit made of a miniscope that attaches to a smartphone and an app, used to… US$ 82.80 Eye & retina HEINE BETA 200 LED Ophthalmoscope HEINE BETA 200 LED Ophthalmoscope: exempt from FDA 510(k). A handheld direct ophthalmoscope with LED illumination used by clinicians to examine the retina… US$ 1,350 Eye & retina Keeler Vantage Plus Binocular Indirect Ophthalmoscope Keeler Vantage Plus Binocular Indirect Ophthalmoscope: FDA 510(k) cleared (K942104). A head-mounted binocular indirect ophthalmoscope (BIO) used by… US$ 4,850 Eye & retina Optomed Smartscope PRO Handheld Fundus Camera Optomed Smartscope PRO Handheld Fundus Camera: FDA 510(k) cleared (K201325). A handheld, battery-operated digital fundus camera for imaging the retina… US$ 6,888 Eye & retina Paxos Scope Smartphone Ophthalmic Camera Paxos Scope Smartphone Ophthalmic Camera: exempt from FDA 510(k). A smartphone-mounted ophthalmic camera adapter for professional photography of the… US$ 1,440 Eye & retina RetinaLyze Retinal Screening Software RetinaLyze Retinal Screening Software: not FDA-cleared. Cloud-based AI software (not a camera) that analyzes fundus photographs and OCT scans for signs of… US$ 18,000 Eye & retina Welch Allyn iExaminer Smartphone Adapter Welch Allyn iExaminer Smartphone Adapter: FDA status not confirmed. A smartphone adapter system and app that let clinicians capture and share images… US$ 954

Glucose monitoring

Glucose monitoring Accu-Chek Guide Glucose Meter Accu-Chek Guide Glucose Meter: FDA 510(k) cleared (K160944). A blood glucose meter that measures glucose in fresh capillary blood on single-use test… US$ 31 Glucose monitoring Dexcom G7 Continuous Glucose Monitor Dexcom G7 Continuous Glucose Monitor: FDA 510(k) cleared (K213919). A wearable continuous glucose monitor whose sensor measures glucose in interstitial… US$ 185 Glucose monitoring Eversense 365 CGM System Eversense 365 CGM System: FDA 510(k) cleared (K241335). Implantable continuous glucose monitor: a sensor placed under the skin by a clinician measures… US$ 199 Glucose monitoring FreeStyle Libre 3 Plus and 2 Plus CGM FreeStyle Libre 3 Plus and 2 Plus CGM: FDA 510(k) cleared (K233537). A continuous glucose monitoring (CGM) system: a small sensor worn on the body… US$ 311 Glucose monitoring OneTouch Verio Reflect Blood Glucose Meter OneTouch Verio Reflect Blood Glucose Meter: FDA 510(k) cleared (K193475). Home blood glucose meter that measures glucose in a fingertip blood sample on… US$ 40

Neuro & EEG

Neuro & EEG BrainBaseline Cognitive Assessment App BrainBaseline Cognitive Assessment App: FDA status not confirmed. Software-only mobile app (iOS) with game-based cognitive tasks covering memory… US$ 3,594 Neuro & EEG BrainMaster EEG & Neurofeedback Systems BrainMaster EEG & Neurofeedback Systems: FDA 510(k) cleared (K990538 K150498). Multichannel EEG amplifiers with software used by clinicians for EEG… US$ 10,794 Neuro & EEG Emotiv EPOC X EEG Headset Emotiv EPOC X EEG Headset: not FDA-cleared. A wireless 14-channel EEG headset with saline-soaked felt sensors, sold for research and… US$ 1,019 Neuro & EEG Muse S Brain Sensing Headband Muse S Brain Sensing Headband: not FDA-cleared. A consumer headband with EEG sensors that tracks brain activity during meditation and sleep and feeds a… US$ 419 Neuro & EEG NeuroSky MindWave Mobile 2 EEG Headset (consumer) NeuroSky MindWave Mobile 2 EEG Headset (consumer): not FDA-cleared. A consumer single-channel EEG headset with a dry forehead sensor (FP1) and ear-clip… US$ 119

Otoscopes

Otoscopes CellScope Oto Smartphone Otoscope (Discontinued) CellScope Oto Smartphone Otoscope (Discontinued): exempt from FDA 510(k). An otoscope attachment that clipped onto a dedicated iPhone case and used the… Otoscopes Remmie 4 Digital Otoscope with AI-Guided Capture Remmie 4 Digital Otoscope with AI-Guided Capture: exempt from FDA 510(k). A wired USB-C digital video otoscope for at-home ear exams that plugs into a… US$ 179 Otoscopes Teslong Wi-Fi Digital Otoscope (Ear Camera) Teslong Wi-Fi Digital Otoscope (Ear Camera): exempt from FDA 510(k). A consumer ear camera (digital otoscope) with a slim camera probe and LEDs that… US$ 70.80 Otoscopes TytoHome Remote Examination Kit TytoHome Remote Examination Kit: FDA 510(k) cleared (K181612). A handheld home examination device with attachments that lets patients record guided exams… US$ 359 Otoscopes WiscMed Wispr Digital Otoscope WiscMed Wispr Digital Otoscope: exempt from FDA 510(k). A digital otoscope head with a built-in camera and round LCD touch screen that mounts on standard… US$ 1,480

Point-of-care lab

Point-of-care lab Abbott i-STAT Alinity Point-of-Care Blood Analyzer Abbott i-STAT Alinity Point-of-Care Blood Analyzer: FDA 510(k) cleared (K153357). A handheld point-of-care blood analyzer that runs single-use test… US$ 10,200 Point-of-care lab Cue COVID-19 Molecular Test (Discontinued) Cue COVID-19 Molecular Test (Discontinued): FDA De Novo authorized (DEN220028). A molecular (nucleic acid amplification) COVID-19 test using a single-use… Point-of-care lab HemoCue Hb 801 Hemoglobin Analyzer HemoCue Hb 801 Hemoglobin Analyzer: FDA 510(k) cleared (K181751). A point-of-care analyzer that measures hemoglobin in capillary or venous whole blood… US$ 2,274 Point-of-care lab Sight OLO Blood Analyzer (CBC) Sight OLO Blood Analyzer (CBC): FDA 510(k) cleared (K190898). A benchtop hematology analyzer that performs a complete blood count with 5-part differential… US$ 14,400

Pulse oximetry

Pulse oximetry BodiMetrics circul pro Ring Pulse Oximeter BodiMetrics circul pro Ring Pulse Oximeter: FDA 510(k) cleared (K221361). A finger-worn ring pulse oximeter that measures SpO2 and pulse rate… US$ 239 Pulse oximetry Masimo MightySat Rx Fingertip Pulse Oximeter Masimo MightySat Rx Fingertip Pulse Oximeter: FDA 510(k) cleared (K181956). Prescription fingertip pulse oximeter that uses Masimo SET (Signal Extraction… US$ 474 Pulse oximetry Nonin Model 3231 USB Pulse Oximeter Nonin Model 3231 USB Pulse Oximeter: FDA 510(k) cleared (K140785). A fingertip pulse oximeter that spot-checks SpO2 and pulse rate and sends readings over… US$ 100

Spirometry & respiratory

Spirometry & respiratory COSMED microQuark PC-Based Spirometer COSMED microQuark PC-Based Spirometer: FDA 510(k) cleared. A small PC-based spirometer that uses a bidirectional digital turbine flow sensor and connects… US$ 1,792 Spirometry & respiratory ndd EasyOne Air Spirometer ndd EasyOne Air Spirometer: FDA 510(k) cleared (K161536). Portable diagnostic spirometer for clinics that measures airflow and volume with ultrasonic… US$ 2,930 Spirometry & respiratory Schiller SPIROVIT SP-1 G2 Spirometer Schiller SPIROVIT SP-1 G2 Spirometer: FDA status not confirmed. A standalone tabletop/portable diagnostic spirometer that measures airflow with an… US$ 2,800 Spirometry & respiratory Spire Health Tag Respiratory Monitor Spire Health Tag Respiratory Monitor: FDA 510(k) cleared (K192952). A small wearable tag attached inside clothing that continuously measures respiratory… US$ 179 Spirometry & respiratory Vitalograph Micro Spirometer Vitalograph Micro Spirometer: FDA 510(k) cleared (K160253). A handheld spirometer using a Fleisch-type pneumotachograph to measure lung function (FVC… US$ 1,520

Stethoscopes

Stethoscopes 3M Littmann CORE Digital Stethoscope 3M Littmann CORE Digital Stethoscope: FDA 510(k) cleared. A professional acoustic stethoscope with an integrated digital module that amplifies and records… US$ 359 Stethoscopes Eko CORE 500™ Digital Stethoscope Eko CORE 500™ Digital Stethoscope: FDA 510(k) cleared (K230111). An electronic stethoscope that amplifies and filters heart, lung and body sounds and… US$ 479

Thermometers

Thermometers Braun ThermoScan 7 Ear Thermometer Braun ThermoScan 7 Ear Thermometer: FDA 510(k) cleared (K103800). A consumer infrared ear (tympanic) thermometer for home use, with a pre-warmed tip and… US$ 75 Thermometers Exergen TAT-5000 Temporal Artery Thermometer Exergen TAT-5000 Temporal Artery Thermometer: FDA 510(k) cleared. A handheld infrared thermometer that measures body temperature by scanning the forehead… US$ 499 Thermometers Microlife NC 200 Non-Contact Forehead Thermometer Microlife NC 200 Non-Contact Forehead Thermometer: FDA 510(k) cleared (K191829). An infrared non-contact forehead thermometer that takes a reading in… US$ 45 Thermometers TempTraq Wearable Bluetooth Temperature Patch TempTraq Wearable Bluetooth Temperature Patch: FDA 510(k) cleared (K201977). A single-use, wearable adhesive patch worn in the armpit that continuously… US$ 29.99

Ultrasound

Ultrasound Butterfly iQ+ Handheld Ultrasound Butterfly iQ+ Handheld Ultrasound: FDA 510(k) cleared (K220068). A single-probe, whole-body handheld ultrasound using a CMUT 'Ultrasound-on-Chip'… US$ 3,599 Ultrasound Clarius C3 HD3 Wireless Ultrasound Clarius C3 HD3 Wireless Ultrasound: FDA 510(k) cleared (K213436). Handheld wireless convex-array ultrasound scanner that sends images to an iOS or Android… US$ 7,194 Ultrasound EchoNous Kosmos Handheld Ultrasound EchoNous Kosmos Handheld Ultrasound: FDA 510(k) cleared (K193518). A handheld point-of-care ultrasound system with probes that connect to a tablet or… US$ 12,000 Ultrasound GE HealthCare Vscan Air SL with Caption AI GE HealthCare Vscan Air SL with Caption AI: FDA 510(k) cleared (K243065). A wireless handheld ultrasound scanner with a dual-headed probe (sector phased… US$ 5,000 Ultrasound Philips Lumify Handheld Ultrasound Philips Lumify Handheld Ultrasound: FDA 510(k) cleared (K242519). A professional app-based ultrasound system: Lumify transducers connect to a compatible… US$ 9,599

Vital-signs monitors

Vital-signs monitors AMD-8400 All-in-One Vital Signs Monitor AMD-8400 All-in-One Vital Signs Monitor: FDA status not confirmed. A portable spot-check monitor that measures non-invasive blood pressure, oxygen… US$ 2,500 Vital-signs monitors Checkme Pro Health Monitor (Viatom) Checkme Pro Health Monitor (Viatom): FDA 510(k) cleared (K150869). A handheld multi-parameter monitor that records ECG, SpO2, pulse rate and temperature… US$ 179 Vital-signs monitors Owlet Dream Sock Baby Monitor Owlet Dream Sock Baby Monitor: FDA De Novo authorized (DEN220091). An over-the-counter infant sock that uses pulse oximetry to monitor pulse rate and… US$ 479 Vital-signs monitors Withings BeamO Withings BeamO: FDA 510(k) cleared (K252474). A handheld home health check-up device combining a 1-lead ECG, a digital stethoscope and a contactless… US$ 323