Heart-Valve, Non-Allograft Tissue

FDA Pre-Market Approval

FDA Class 3 ·EDWARDS INTUITY Elite Valve System

Temporary Non-Roller Type Right Heart Support Blood Pump

FDA Pre-Market Approval

FDA Class 3 ·Impella RP with SmartAssist System

Occluder, Patent Ductus, Arteriosus

FDA Pre-Market Approval

FDA Class 3 ·AMPLATZER DUCT OCCLUDER

Implant, Cochlear

FDA Pre-Market Approval

FDA Class 3 ·NUCLEUS COCHLEAR IMPLANT SYSTEM

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·CAPSURE VDD 2 LEAD/ VITATRON BRILLIANT S+VDD LEAD

Implant, Dermal, For Aesthetic Use

FDA Pre-Market Approval

FDA Class 3 ·RESTYLANE INJECTABLE GEL

Stent, Coronary

FDA Pre-Market Approval

FDA Class 3 ·POWERSAIL CORONARY DILATATION CATHETER

Pulmonary Valve Prosthesis Percutaneously Delivered

FDA Pre-Market Approval

Edwards Commander Delivery System

Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)

FDA Pre-Market Approval

FDA Class 3 ·VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBC IGM REAGENT PACK, VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBC IGM CALIBRATOR

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·Aurora EV ICD

Device, Thermal Ablation, Endometrial

FDA Pre-Market Approval

FDA Class 3 ·HER OPTION CRYOABLATION THERAPY SYSTEM

Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval

FDA Class 3 ·EPT-1000 CARDIAC ABLATION SYSTEM

Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

FDA Pre-Market Approval

FDA Class 3 ·Restore, Itrel, Synergy and Intellis Spinal Cord Stimulation System and Pisces, Specify and Vectris Sprinal Cord Stimula

SeQureTM Snare System

FDA UDI

Lifetech Scientific (Shenzhen) Co., Ltd.·06938370118091·The SeQureTM Snare System consists of a snare, ...

SeQureTM Snare System

FDA UDI

Lifetech Scientific (Shenzhen) Co., Ltd.·06938370118114·The SeQureTM Snare System consists of a snare, ...

SeQureTM Snare System

FDA UDI

Lifetech Scientific (Shenzhen) Co., Ltd.·06938370118053·The SeQureTM Snare System consists of a snare, ...

eVox System

FDA UDI

EVOKE NEUROSCIENCE, INC.·00867606000304·The eVox System is intended for the acquisition...

SeQureTM Snare System

FDA UDI

Lifetech Scientific (Shenzhen) Co., Ltd.·06938370118015·The SeQureTM Snare System consists of a snare, ...

SeQureTM Snare System

FDA UDI

Lifetech Scientific (Shenzhen) Co., Ltd.·06938370118107·The SeQureTM Snare System consists of a snare, ...

SeQureTM Snare System

FDA UDI

Lifetech Scientific (Shenzhen) Co., Ltd.·06938370118084·The SeQureTM Snare System consists of a snare, ...