3,777 results · 20ms · Sources: EU EUDAMED, US FDA

Wearable Automated External Defibrillator

FDA Pre-Market Approval
FDA Class 3 ·LIFEVEST WEARABLE DEFIBRILLATOR

Intraocular Lens

FDA Pre-Market Approval
FDA Class 3 ·One-Piece IOLs with Daisy-Wheel packaging configuration, TENIC iTEC Preloaded Delivery System, TECNIS SmartLOAD Delivery

Device, Thermal Ablation, Endometrial

FDA Pre-Market Approval
FDA Class 3 ·MICROSULIS MICROWAVE ENDOMETRIAL ABLATION (MEA) SYSTEM

System, Hyperthermia, Rf/Microwave (Benign Prostatic Hyperplasia),Thermotherapy

FDA Pre-Market Approval
FDA Class 3 ·PROSTATRON

Stent, Coronary

FDA Pre-Market Approval
FDA Class 3 ·BX VELOCITY STENT ON RAPTORRAIL STENT DELIVERY SYSTEM

Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled

FDA Pre-Market Approval
FDA Class 3 ·SIENTRA SILICONE GEL BREAST IMPLANTS

Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled

FDA Pre-Market Approval
FDA Class 3 ·Sientra Silicone Gel Breast Implants

Joint, Temporomandibular, Implant

FDA Pre-Market Approval
FDA Class 3 ·TMJ FOSSA-EMINENCE/CONDYLAR PROSTHESES

Defibrillator, Implantable, Dual-Chamber

FDA Pre-Market Approval
FDA Class 3 ·SWIFT(TM) 1CT SERIES 4040 DEFIBRILLATION LEAD

Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled

FDA Pre-Market Approval
FDA Class 3 ·MENTOR MEMORYSHAPE BREAST IMPLANTS

Dressing, Wound And Burn, Interactive

FDA Pre-Market Approval
FDA Class 3 ·APLIGRAF (GRAFTSKIN)

Device, Thermal Ablation, Endometrial

FDA Pre-Market Approval
FDA Class 3 ·Minitouch 3.8 Era System (Minitouch System)

Coronary Drug-Eluting Stent

FDA Pre-Market Approval
FDA Class 3 ·EluNIR™ Ridaforolimus Eluting Coronary Stent System

Hepatitis Viral B Dna Detection

FDA Pre-Market Approval
FDA Class 3 ·Aptima HBV Quant Assay

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

FDA Pre-Market Approval
FDA Class 3 ·Arctic Front Advance and Arctic Front Advance Pro

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

FDA Pre-Market Approval
FDA Class 3 ·TactiFlex™ Ablation CatTactiFlex™ Ablation Catheter, Sensor Enabled™heter, Sensor Enabled™, TactiSys™ Quartz Equipment,

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

FDA Pre-Market Approval
FDA Class 3 ·Arctic Front and Arctic Front Advance Cardiac CryoAlbation Catheters

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

FDA Pre-Market Approval
FDA Class 3 ·TACTICATH QUARTZ SET

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

FDA Pre-Market Approval
FDA Class 3 ·TactiCath™ Contact Force Ablation Catheter, Sensor Enabled™

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

FDA Pre-Market Approval
FDA Class 3 ·Arctic Front Advance Pro Cryoballoon Catheter