Drug Eluting Permanent Right Ventricular (Rv) Or Right Atrial (Ra) Pacemaker Electrodes

FDA Pre-Market Approval

FDA Class 3 ·CapSure Epicardial Pacing Lead

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval

FDA Class 3 ·SMARTVIEW hotspot

Hybrid Stent Graft, Thoracic Aortic Lesion Treatment

FDA Pre-Market Approval

FDA Class 3 ·Thoraflex Hybrid

Pump, Infusion, Implanted, Programmable

FDA Pre-Market Approval

FDA Class 3 ·SynchroMed Infusion System, Ascends Intrathecal Catheters

Device, Angioplasty, Laser, Coronary

FDA Pre-Market Approval

FDA Class 3 ·CVX-300 and CVX-300-P Excimer Laser Systems

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·CapSureFix MRI Lead

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·Cobalt MRI ICD, Cobalt XT MRI ICD, Crome MRI ICD, Evera MRI DF-1 ICD, Evera MRI ICD, Evera S DR ICD, Evera S VR ICD, Eve

Agent, Absorbable Hemostatic, Non-Collagen Based

FDA Pre-Market Approval

FDA Class 3 ·SURGICEL FIBRILLAR Absorbable Hemostat and SURGICEL NU-KNIT Absorbable Hemostat

FDA Pre-Market Approval

ETI-AB-COREK PLUS Assay

Agent, Absorbable Hemostatic, Non-Collagen Based

FDA Pre-Market Approval

FDA Class 3 ·Surgicel Nu-Knit Absorbable Hemostat

Stent, Superficial Femoral Artery

FDA Pre-Market Approval

FDA Class 3 ·EverFlex Self-Expanding Peripheral Stent System

Device, Thermal Ablation, Endometrial

FDA Pre-Market Approval

FDA Class 3 ·MINERVA ENDOMETRIAL ABLATION SYSTEM

Stimulator, Invasive Bone Growth

FDA Pre-Market Approval

FDA Class 3 ·EBI OSTEOGEN IMPLANTABLE BONE GROWTH STIMULATORS

Device, Thermal Ablation, Endometrial

FDA Pre-Market Approval

FDA Class 3 ·GYNECARE THERMACHOICE II

Automated External Defibrillators (Non-Wearable)

FDA Pre-Market Approval

FDA Class 3 ·AED Pro Device

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

FDA Pre-Market Approval

FDA Class 3 ·THERAPY DUAL 8 CATHETER AND IBI-1500T6 CARDIAC ABLATION GENERATOR

Hepatitis Viral B Dna Detection

FDA Pre-Market Approval

FDA Class 3 ·Cobas HBV

Drug Eluting Permanent Right Ventricular (Rv) Or Right Atrial (Ra) Pacemaker Electrodes

FDA Pre-Market Approval

FDA Class 3 ·CapSure Epicardial Pacing Lead

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval

FDA Class 3 ·Assurity MRI Endurity MRI family of Pacemakers

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·VENTAK AV/VR/PRIZM