Extended Depth Of Focus Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·IC-8 Apthera Intraocular Lens (IOL)

Pump, Infusion, Implanted, Programmable

FDA Pre-Market Approval

FDA Class 3 ·Intera 3000 Hepatic Artery Infusion Pump

Transcatheter Septal Occluder

FDA Pre-Market Approval

FDA Class 3 ·Amplatzer™ Talisman™ PFO Occluder

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·EMBLEM S-ICD Lead

System, Colorectal Neoplasia, Dna Methylation And Hemoglobin Detection

FDA Pre-Market Approval

FDA Class 3 ·Cologuard®

Acute Coronary Syndrome Event Detector

FDA Pre-Market Approval

FDA Class 3 ·Guardian® System

Device, Incontinence, Mechanical/Hydraulic

FDA Pre-Market Approval

FDA Class 3 ·SPHINCTER 800 URINARY CONTROL SYSTEM

Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Metal/Polymer, Mobile Bearing

FDA Pre-Market Approval

FDA Class 3 ·ZIMMER NEXGEN LPS-FLEX MOBILE AND LPS-MOBILE BEARING KNEE SYSTEM

Device, Hemostasis, Vascular

FDA Pre-Market Approval

FDA Class 3 ·ANGIO-SEAL VASCULAR CLOSURE DEVICE

Drug-Eluting Peripheral Transluminal Angioplasty Catheter

FDA Pre-Market Approval

FDA Class 3 ·LUTONIX DRUG COATED BALLOON PTA CATHETER

Stimulator, Electrical, Implantable, For Incontinence

FDA Pre-Market Approval

FDA Class 3 ·Neuspera Sacral Neuromodulation System

Stimulator, Electrical, Implanted, For Parkinsonian Tremor

FDA Pre-Market Approval

FDA Class 3 ·BRIO PATIENT PROGRAMMER

Total, Prostate Specific Antigen (Noncomplexed & Complexed) For Detection Of Prostate Cancer

FDA Pre-Market Approval

FDA Class 3 ·ACCESS HYBRITECH PSA REAGENTS ON THE ACCESS IMMUNOASSAY SYSTEM

Glue, Surgical, Arteries

FDA Pre-Market Approval

FDA Class 3 ·CRYOLIFE BIOGLUE SURGICAL ADHESIVE

System, Test, Her-2/Neu, Ihc

FDA Pre-Market Approval

FDA Class 3 ·HERCEP TEST

Defibrillator, Implantable, Dual-Chamber

FDA Pre-Market Approval

FDA Class 3 ·ISOLINE 2CR

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

FDA Pre-Market Approval

FDA Class 3 ·EPT-1000 XP CARDIAC ABLATION SYSTEM

Pulse-Generator, Single Chamber, Single

FDA Pre-Market Approval

FDA Class 3 ·INTERTACH TM IMPLANTABLE PACEMAKER PULSE

Agent, Absorbable Hemostatic, Collagen Based

FDA Pre-Market Approval

FDA Class 3 ·INSTAT COLLAGEN ABSORBABLE HEMOSTAT

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·EVERA S DR ICD,EVERA S VR ICD, EVERA XT DR ICD,EVERA XT VR ICD