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FDA 510(k)

FDA Class 2 ·Anesthesiology

Artio Medical Corporation

Manufacturer

🇺🇸 United States

VARIAX 2 SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

AKTINA MEDICAL PHYSICS CORPORATION ACTIVE BREATHING COORDINATOR (ABC)

FDA 510(k)

FDA Class 2 ·Radiology

Ventricular (Assist) Bypass

FDA Pre-Market Approval

FDA Class 3 ·HEARTMATE XVE LVAS

Ventricular (Assist) Bypass

FDA Pre-Market Approval

FDA Class 3 ·HEARTMATE II LVAS

Ventricular (Assist) Bypass

FDA Pre-Market Approval

FDA Class 3 ·THORATEC VAD SYSTEM

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·SUBCUTANEOUS IMPLANTABLE DEFIBRILLATOR (S-ICD) SYSTEM

Catheter, Coronary, Atherectomy

FDA Pre-Market Approval

FDA Class 3 ·ANGIOJET RHEOLYTIC THROMBECTOMY LF140 CATHETER

Catheter, Coronary, Atherectomy

FDA Pre-Market Approval

FDA Class 3 ·AngioJet Thrombectomy System

Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter

FDA Pre-Market Approval

FDA Class 3 ·IntellaTip MiFi Filter Module and IntellaTip MiFi Reference Cable

MedR-AR Services B.V.

Authorized representative

🇳🇱 Netherlands·13 Manufacturers·31 Devices

Expression MRI Patient Monitoring System (Model 865214)

FDA UDI

Philips Ds North America LLC·00884838016064·Expression MRI Patient Vital Signs Monitor, Wir...

MediMark Europe Sarl.

Authorized representative

🇫🇷 France·35 Manufacturers·3394 Devices

Maxcert Eurep

Authorized representative

🇩🇪 Germany·65 Manufacturers·8 Devices

mdi Europa GmbH

Authorized representative

🇩🇪 Germany·132 Manufacturers·4741 Devices

MedEnvoy Global BV

Authorized representative

🇳🇱 Netherlands·143 Manufacturers·2306 Devices

Emergo Europe B.V.

Authorized representative

🇳🇱 Netherlands·900 Manufacturers·22100 Devices

Wellkang Ltd

Authorized representative

259 Manufacturers·3500 Devices