SJM CONFIRM IMPLANTABLE CARDIAC MONITOR

FDA 510(k)

FDA Class 2 ·Cardiovascular

SLEUTH IMPLANTABLE ECG MONITORING SYSTEM

FDA 510(k)

FDA Class 2 ·Cardiovascular

SJM CONFIRM IMPLANTABLE CARDIAC MONITOR (ICM)

FDA 510(k)

FDA Class 2 ·Cardiovascular

myMerlin Mobile Application (Android), myMerlin Mobile Application (iOS)

FDA 510(k)

FDA Class 2 ·Cardiovascular

Confirm Rx Insertable Cardiac Monitor

FDA 510(k)

FDA Class 2 ·Cardiovascular

Confirm Rx Insertable Cardiac Monitor (ICM) System

FDA 510(k)

FDA Class 2 ·Cardiovascular

SLEUTH AT IMPLANTABLE CARDIAC MONITORING SYSTEM -6 CM AND 8CM ANTENNA, PERSONAL DIAGNOSTICS MANAGER (PDM) ACCESSORY KIT

FDA 510(k)

FDA Class 2 ·Cardiovascular

SJM CONFIRM MODEL DM2100 IMPLANTABLE CARDIAC MONITOR AND MODEL DM2100A PATIENT ACTIVATOR

FDA 510(k)

FDA Class 2 ·Cardiovascular

MXC Transparent Face Mask

Basic UDI-DI

EU MDR · Eu Md Class 1 ·Globus (Shetland) Ltd·1 device

Recorder, Event, Implantable Cardiac, (Without Arrhythmia Detection)

FDA classification

FDA Class 2 ·Recorder, Event, Implantable Cardiac, (Without Arrhythmia Detection)

MFC Global Ltd.

Manufacturer

🇮🇱 Israel

Leg Lift

FDA registration

FLOW STATE INNOVATION·1 product·🇺🇸 United States

MEC Medical Limited UK

Manufacturer

2 Importers

DXC-RMH

FDA registration

DRGEM Corporation (Gimcheon Factory)·1 product·🇰🇷 South Korea

DXC-RMH

FDA registration

DRGEM CORPORATION·1 product·🇰🇷 South Korea

Exces Eyewear

FDA registration

EASTERN STATES EYEWEAR, INC.·1 product·🇺🇸 United States

Xiamen Atlantis Mfc Co., Ltd.

Manufacturer

🇨🇳 China

3 M.C. Società per azioni

Manufacturer

🇮🇹 Italy·5 Basic UDI-DIs·7 Devices

MAC SURGICAL

FDA registration

MAC SURGICAL·1 product·🇦🇺 Australia

WHEELED

FDA registration

MAC MEDICAL·1 product·🇺🇸 United States