Stent, Superficial Femoral Artery

FDA Pre-Market Approval

FDA Class 3 ·MISAGO RX Self-expanding Peripheral Stent

ADVANCED OPHTHALMIC SYSTEMS LTD

FDA registration

ADVANCED OPHTHALMIC SYSTEMS LTD·1 product·🇬🇧 United Kingdom

Cinesteam®

FDA registration

CEMAG CARE·1 product·🇫🇷 France

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval

FDA Class 3 ·OG(R) CARDIAC PACING SYSTEM

Wearable Automated External Defibrillator

FDA Pre-Market Approval

FDA Class 3 ·LifeVest Wearable Defibrillator

Ventilator, High Frequency

FDA Pre-Market Approval

FDA Class 3 ·MODEL 3100A HIGH FREQUENCY OCILLATORY VENTILATOR

diaphragm, contraceptive

FDA registration

EIS CORPORATION·1 product·🇰🇷 South Korea

PESSARY CUBE

FDA registration

EIS CORPORATION·1 product·🇰🇷 South Korea

Glue, Surgical, Arteries

FDA Pre-Market Approval

FDA Class 3 ·BioGlue Surgical Adhesive

System, Laser, Transmyocardial Revascularization

FDA Pre-Market Approval

FDA Class 3 ·TMR Holmium Laser System

SAM SUNG OPTICAL

FDA 510(k)

FDA Class 1 ·Ophthalmic

Occluder, Patent Ductus, Arteriosus

FDA Pre-Market Approval

FDA Class 3 ·AMPLATZER DUCT OCCLUDER

Occluder, Patent Ductus, Arteriosus

FDA Pre-Market Approval

FDA Class 3 ·AMPLATZER SEPTAL OCCLUDER

KWANG WON OPTICAL CO. (Protective goggles)

FDA registration

KWANG WON OPTICAL CO.·1 product·🇰🇷 South Korea

KWANG WON OPTICAL CO.

FDA registration

KWANG WON OPTICAL CO.·1 product·🇰🇷 South Korea

KWANG WON OPTICAL CO.

FDA registration

KWANG WON OPTICAL CO.·1 product·🇰🇷 South Korea

SUNGLASSES(NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE)

FDA registration

ONNURY OPTICAL CO.·1 product·🇰🇷 South Korea

FRAME, SPECTACLE

FDA registration

ONNURY OPTICAL CO.·1 product·🇰🇷 South Korea

Pulmonary Valve Prosthesis Percutaneously Delivered

FDA Pre-Market Approval

Edwards SAPIEN 3 Pulmonic Delivery System

Percutaneously Delivered Prostheses And Tricuspid Valves

FDA Pre-Market Approval

FDA Class 3 ·EVOQUE Tricuspid Delivery System, EVOQUE Dilator Kit, EVOQUE Loading System