Implicity

Manufacturer

🇫🇷 France·3 Basic UDI-DIs·3 Devices

SignalHF

FDA registration

IMPLICITY·2 products·🇫🇷 France

IM007 (ILR ECG Analyzer)

FDA registration

IMPLICITY·2 products·🇫🇷 France

GENERAL MEDICINE DIAGNOSIS AND MONITORING INSTRUMENTS - SOFTWARE ACCESSORIES

Device

EU MDD · Eu Md Class 1 ·Implicity·No longer on the market·2 countries

Alert Management Solution

Device

EU MDD · Eu Md Class 1 ·Implicity·On the market·4 countries

GENERAL MEDICINE DIAGNOSIS AND MONITORING INSTRUMENTS - SOFTWARE ACCESSORIES

Device

EU MDD · Eu Md Class 1 ·Implicity·On the market·4 countries

IM007

FDA 510(k)

FDA Class 2 ·Cardiovascular

SignalHF (IM008)

FDA 510(k)

FDA Class 2 ·Cardiovascular

Ventilator, High Frequency

FDA Pre-Market Approval

FDA Class 3 ·LifePulse High Frequency Ventilator

Heart Failure Analysis solution

Basic UDI-DI

EU MDD · Eu Md Class 1 ·Implicity·1 device

Alert Management Solution

Basic UDI-DI

EU MDD · Eu Md Class 1 ·Implicity·1 device

ILR ECG Analyzer

Basic UDI-DI

EU MDD · Eu Md Class 1 ·Implicity·1 device

Ataxiagraph

FDA classification

FDA Class 1 ·Ataxiagraph

Ataxiagraph With Interpretive Software

FDA classification

FDA Class 1 ·Ataxiagraph With Interpretive Software

Software Algorithm Device To Assist Users In Digital Pathology

FDA classification

FDA Class 2 ·Software Algorithm Device To Assist Users In Digital Pathology

Digital Cervical Cytology Slide Imaging System With Artificial Intelligence Algorithm

FDA classification

FDA Class 2 ·Digital Cervical Cytology Slide Imaging System With Artificial Intelligence Algorithm

Simplicity Devices S3M3

FDA registration

Simplicity·1 product·🇺🇸 United States

Spinal Simplicity, LLC

Manufacturer

🇺🇸 United States

Fortuna Helix GenPredict: Disease

FDA registration

FORTUNA HELIX·1 product·🇰🇷 South Korea

CeQur Simplicity Inserter

FDA registration

Biomerics Winston-Salem·1 product·🇺🇸 United States