Wearable Automated External Defibrillator

FDA Pre-Market Approval

FDA Class 3 ·LIFEVEST WEARABLE DEFIBRILLATOR

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

Biologic Material, Dental

FDA Pre-Market Approval

FDA Class 3 ·STRAUMANN EMDOGAIN(R)

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

Sensor, Glucose, Invasive

FDA Pre-Market Approval

FDA Class 3 ·Guardian Sensor (3) System

Pump, Infusion, Implanted, Programmable

FDA Pre-Market Approval

FDA Class 3 ·MEDTRONIC SYNCHROMED INFUSION

TRANSVENOUS, PERMANENT TINED TARGET TIP PACING LEADS/TRANSVENOUS, PERMANENT SCREW-IN PACING LEADS

FDA 510(k)

FDA Class 3 ·Cardiovascular

MODEL 2188 CORONARY SINUS LEAD.

FDA 510(k)

FDA Class 3 ·Cardiovascular

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval

FDA Class 3 ·PURE VISION (BALAFILCON A) VISIBILITY TINTED CONTACT LENS

Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)

FDA Pre-Market Approval

FDA Class 3 ·BIO-RAD MONOLISA ANTI-HBS EIA

Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)

FDA Pre-Market Approval

FDA Class 3 ·MONOLISA ANTI-HBS EIA

Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)

FDA Pre-Market Approval

FDA Class 3 ·MONOLISA ANTI-HBS EIA AND MONOLISA ANTI-HBS CALIBRATOR KIT

Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)

FDA Pre-Market Approval

FDA Class 3 ·BIO-RAD MONOLISA ANTI -HBS EIA