Excimer Laser System

FDA Pre-Market Approval

FDA Class 3 ·SVS APEX APEX EXIMER LASER WORKSTATION

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·MODEL 3120 ZOOM LATITUDE PROGRAMMING SYSTEM

Automated Breast Ultrasound

FDA Pre-Market Approval

FDA Class 3 ·INVENIA ABUS -- AUTOMATED BREAST ULTRASOUND SYSTEM

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·Autogen, Dynagen, Inogen, and Origen NG3 ICDs and Resonate, Momentum, Vigilant, and Perciva NG4 ICDs

Filler, Recombinant Human Bone Morphogenetic Protein, Collagen Scaffold, Osteoinduction

FDA Pre-Market Approval

FDA Class 3 ·INFUSE BONE GRAFT

Filler, Recombinant Human Bone Morphogenetic Protein, Collagen Scaffold With Metal Prosthesis, Osteoinduction

FDA Pre-Market Approval

FDA Class 3 ·INFUSE BONE GRAFT-LT-CAGE LUMBAR TAPERED FUSION DEVICE

Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P)

FDA Pre-Market Approval

FDA Class 3 ·Valitude and Visionist Non-MRI CRT-Ps and Valitude X4 and Visionist X4 MRI CRT-Ps

Stimulator, Bone Growth, Non-Invasive

FDA Pre-Market Approval

FDA Class 3 ·ORTHOLOGIC 1000 SC

Test, Prostate Specific Antigen, Free, (Noncomplexed) To Distinguish Prostate Cancer From Benign Conditions

FDA Pre-Market Approval

FDA Class 3 ·ACCESS HYBRITECH FREE PSA REAGENTS ON THE ACCESS IMMUNOASSAY SYSTEMS

Kit, Test, Alpha-Fetoprotein For Neural Tube Defects

FDA Pre-Market Approval

FDA Class 3 ·ACCESS AFP REAGENTS ON THE ACCESS IMMUNOASSAY SYSTEMS

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 SYSTEMS

Processor, Cervical Cytology Slide, Automated

FDA Pre-Market Approval

FDA Class 3 ·BD PREPSTAIN SYSTEM

Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Ceramic/Metal, Cemented Or Uncemented

FDA Pre-Market Approval

FDA Class 3 ·TRIDENT SYSTEMS

Reader, Cervical Cytology Slide, Automated

FDA Pre-Market Approval

FDA Class 3 ·THINPREP (R) IMAGING SYSTEM

Intracranial Coil-Assist Stent

FDA Pre-Market Approval

FDA Class 3 ·Neuroform Atlas® Stent System

Assay,Enzyme Linked Immunosorbent,Parvovirus B19 Igm

FDA Pre-Market Approval

FDA Class 3 ·ZEUS ELISA PARVOVIRUS B19 IGM TEST SYSTEM

Reader, Cervical Cytology Slide, Automated

FDA Pre-Market Approval

FDA Class 3 ·ThinPrep Integrated Imager

Assay,Enzyme Linked Immunosorbent,Parvovirus B19 Igg

FDA Pre-Market Approval

FDA Class 3 ·ZEUS ELISA PARVOVIRUS B19 IGG TEST SYSTEM

Stimulator, Bone Growth, Non-Invasive

FDA Pre-Market Approval

FDA Class 3 ·OL1000 DUAL COIL MEDIUM BONE GROWTH STIMULATION DEVICE

Stimulator, Autonomic Nerve, Implanted For Epilepsy

FDA Pre-Market Approval

FDA Class 3 ·VNS Therapy System