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 ·ARC(TM) BALLOON CORONARY DILATATION CATHETERS

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·ORACLE MEGASONICS FIVE-64 PTCA CATHETER

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

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

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

System, Colorectal Neoplasia, Dna Methylation And Hemoglobin Detection

FDA Pre-Market Approval

FDA Class 3 ·COLOGUARD

System, Colorectal Neoplasia, Dna Methylation And Hemoglobin Detection

FDA Pre-Market Approval

FDA Class 3 ·Cologuard

Pump, Infusion, Implanted, Programmable

FDA Pre-Market Approval

FDA Class 3 ·SynchroMed Infusion System and Ascenda Intrathecal Catheters

System, Colorectal Neoplasia, Rna Markers And Hemoglobin Detection

FDA Pre-Market Approval

FDA Class 3 ·ColoSense®

Somatic Gene Mutation Detection System

FDA Pre-Market Approval

FDA Class 3 ·THERASCREEN KRAS RGQ PCR KIT

System, Colorectal Neoplasia, Rna Markers And Hemoglobin Detection

FDA Pre-Market Approval

FDA Class 3 ·ColoSense

Permanent Defibrillator Electrodes

FDA Pre-Market Approval

FDA Class 3 ·Tunneling Tool