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

FDA Pre-Market Approval

FDA Class 3 ·DiamondTemp Ablation System

Device, Thermal Ablation, Endometrial

FDA Pre-Market Approval

FDA Class 3 ·MINERVA ENDOMETRIAL ABLATION SYSTEM

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

FDA Pre-Market Approval

FDA Class 3 ·UROLOGIX TARGIS SYSTEM

Agent, Bulking, Injectable For Gastro-Urology Use

FDA Pre-Market Approval

FDA Class 3 ·Bulkamid Urethral Bulking System

Device, Thermal Ablation, Endometrial

FDA Pre-Market Approval

FDA Class 3 ·NOVASURE IMPEDANCE CONTROLLED ENDOMETRIAL ABLATION SYSTEM

Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Ceramic/Metal, Cemented Or Uncemented

FDA Pre-Market Approval

FDA Class 3 ·R3 DELTA CERAMIC HIP SYSTEM

Device, Thermal Ablation, Endometrial

FDA Pre-Market Approval

FDA Class 3 ·HYDRO THERMABLATOR ENDOMETRIAL ABLATION SYSTEM

Wearable Automated External Defibrillator

FDA Pre-Market Approval

FDA Class 3 ·LIFEVEST WEARABLE DEFIBRILLATOR

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