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

FDA Pre-Market Approval

FDA Class 3 ·LSC REVISION SYSTEM

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

FDA Pre-Market Approval

FDA Class 3 ·LSC TOTAL KNEE SYSTEM

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·ARC(TM) BALLOON CORONARY DILATATION CATHETERS

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·ORACLE(TM) CORONARY BALLOON DILATATION CATHETER

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·FACT(TM)AND ARC BALLOON CORNARY DILATATION CATHETERS

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·FACT(TM)AND ARC BALLOON CORNARY DILATATION CATHETERS

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·FACT(TM)AND ARC BALLOON CORNARY DILATATION CATHETERS

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·FACT, ARC, LYNX AND GUARDIAN BALLOON CORONARY DILATATION CATHETERS

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·ORACLE MEGASONICS FIVE-64 PTCA CATHETER

Automated External Defibrillators (Non-Wearable)

FDA Pre-Market Approval

FDA Class 3 ·HeartSine Technologies LLC's samaritan Public Access Automated External Defibrillators and Accessories

Automated External Defibrillators (Non-Wearable)

FDA Pre-Market Approval

FDA Class 3 ·HeartSine Technologies LLC's samaritan Public Access Automated External Defibrillators and Accessories

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·CATHSCANNER ORACLE MICRO PTCA CATHETER FACT & ARC BALLOON CORONARY DILATATION CATHETER

Stimulator, Invasive Bone Growth

FDA Pre-Market Approval

FDA Class 3 ·OSTEOGEN IMPLANTABLE BONE GROWTH STIMULATOR

Implant, Corneal, Refractive

FDA Pre-Market Approval

FDA Class 3 ·INTACS (INTRASTROMAL CORNEAL RING SEGMENTS)

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·VITALITY HE, RENEWAL 3 AND RENEWAL 3RF FAMILIES OF ICDS

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·VITALITY HE, RENEWAL 3 AND RENEWAL 3RF FAMILIES OF ICDS

System, Colorectal Neoplasia, Dna Methylation And Hemoglobin Detection

FDA Pre-Market Approval

FDA Class 3 ·Epi proColon

System, Colorectal Neoplasia, Dna Methylation And Hemoglobin Detection

FDA Pre-Market Approval

FDA Class 3 ·Epi proColon

Stimulator, Invasive Bone Growth

FDA Pre-Market Approval

FDA Class 3 ·SPF SPINAL FUSION STIMULATOR

Implant, Corneal, Refractive

FDA Pre-Market Approval

FDA Class 3 ·INTACS PRESCRIPTION INSERTS