SPOTCHEM II Amy-wide

Device

EU IVDD · Eu Ivd General ·ARKRAY Factory, Inc.·On the market

AMIS*PACS FLEXSERVER G2

Device

EU MDD · Eu Md Class 2b ·ICZ.HEA a.s.·On the market·2 countries

Multi-Dop Xdigital (+CO2)

FDA registration

Compumedics Germany GmbH·2 products·🇩🇪 Germany

TRANSPORT MEDIUM AMIES

FDA 510(k)

FDA Class 1 ·Microbiology

AMI CARDIO-PAD

FDA 510(k)

FDA Class 2 ·Cardiovascular

AMIES TRANSPORT MEDIUM

FDA 510(k)

FDA Class 1 ·Microbiology

AMIES TRANSPORT MEDIA

FDA 510(k)

FDA Class 1 ·Microbiology

Amis K Long

FDA 510(k)

FDA Class 2 ·Orthopedic

LABSYSTEM™ PRO

FDA UDI

BOSTON SCIENTIFIC CORPORATION·00191506004392·LABSYSTEM™ PRO EP Review Workstation Software

Eko Analysis Software

FDA UDI

Eko Devices, Inc.·00850010298030·The Eko Analysis Software is intended to provid...

Garmin ECG App

FDA UDI

Garmin International, Inc.·00860009117709·

Fitbit Irregular Rhythm Notifications

FDA UDI

FITBIT, INC.·00810038852720·The Fitbit Irregular Rhythm Notifications is a ...

ECG 2.0 App

FDA UDI

APPLE INC.·00190199649286·ECG Watch App (version 2.0)

ECG-AI LEF

FDA UDI

Anumana, Inc.·00860007426407·The Low Ejection Fraction AI-ECG Algorithm inte...

Cardiologs Platform

FDA UDI

CARDIOLOGS TECHNOLOGIES·B273CEA0·Cardiologs ECG analysis platform

VectraplexECG System

FDA UDI

VECTRACOR INC·00857175006029·VectraplexECG System with Cardio Electrical Bio...

ECG App

FDA UDI

APPLE INC.·00190198909534·

LABSYSTEM™ PRO

FDA UDI

BOSTON SCIENTIFIC CORPORATION·08714729884002·LABSYSTEM™ PRO EP Review Workstation Software, ...

RhythmAnalytics

FDA UDI

BIOFOURMIS SINGAPORE PTE. LTD.·08885018690014·

Premier Heart MCG Analysis Software

FDA UDI

PREMIER HEART, LLC·B320MCGC0·Premier Heart MCG Analysis Cluster software, in...