Catheter, Coronary, Atherectomy

FDA Pre-Market Approval

FDA Class 3 ·DIAMONDBACK 360 CORONARY ORBITAL ATHERECTOMY SYSTEM

Pump, Drug Administration, Closed Loop

FDA Pre-Market Approval

FDA Class 3 ·GENESA(R) SYSTEM

Stimulator, Bone Growth, Non-Invasive

FDA Pre-Market Approval

FDA Class 3 ·PHYSIO-STIM BONE GROWTH STIMULATOR

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

FDA Pre-Market Approval

FDA Class 3 ·ZIMMER NEXGEN LPS-FLEX MOBILE/LPS-MOBILE BEARING KNEE SYSTEMS

Implanted Electrical Device Intended For Treatment Of Fecal Incontinence

FDA Pre-Market Approval

FDA Class 3 ·InterStim Therapy System, Verify Evaluation System

Stimulator, Electrical, Implantable, For Incontinence

FDA Pre-Market Approval

FDA Class 3 ·Interstim Therapy System, Verify Evaluation System

Glue, Surgical, Arteries

FDA Pre-Market Approval

FDA Class 3 ·BIOGLUE SURGICAL ADHESIVE

Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval

FDA Class 3 ·NAVISTAR RMT DIAGNOSTIC/ABLATION STEERABLE TIP CATHETER

Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval

FDA Class 3 ·NAVISTAR RMT THERMOCOOL DIAGNOSTIC/ABLATION STEERABLE TIP CATHETER

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

FDA Pre-Market Approval

FDA Class 3 ·NAVISTAR RMT DS DIAGNOSTIC/ABLATION STEERABLE TIP CATHETER

Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval

FDA Class 3 ·NAVISTAR RMT CATHETER FAMILY

System, Test, Her-2/Neu, Ihc

FDA Pre-Market Approval

FDA Class 3 ·PATHWAY ANTI-HER 2INEU (4B5) RABBIT MONOCLONAL PRIMARY ANTIBODY

Wearable Automated External Defibrillator

FDA Pre-Market Approval

FDA Class 3 ·LIFEVEST WEARABLE DEFIBRILLATOR

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·JEWEL ACTIVE CAN & JEWEL PLUS ACTIVE CAN ARRHYTHMIA MGMT SYSTEMS

VISITHERM

FDA 510(k)

FDA Class 3 ·Obstetrics/Gynecology

Biologic Material, Dental

FDA Pre-Market Approval

FDA Class 3 ·STRAUMANN EMDOGAIN(R)

Device, Hemostasis, Vascular

FDA Pre-Market Approval

FDA Class 3 ·CELT ACD VASCULAR CLOSURE DEVICE

Reherniation Reduction Device

FDA Pre-Market Approval

FDA Class 3 ·Barricaid Anular Closure Device (ACD)

Reherniation Reduction Device

FDA Pre-Market Approval

FDA Class 3 ·BARRICAID ANULAR CLOSURE DEVICE (ACD)

Device, Hemostasis, Vascular

FDA Pre-Market Approval

FDA Class 3 ·CELT ACD Vascular Closure Device