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

FDA Pre-Market Approval

FDA Class 3 ·ZIMMER NEXGEN LPS-FLEX MOBILE AND LPS MOBILE BEARING KNEE SYSTEM

Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus

FDA Pre-Market Approval

FDA Class 2 ·ARCHITECT ANTI-HCV ASSAY; ARCHITECT ANTI-HCV CALIBRATOR; ARCHITECT ANTI-HCV CONTROL

Ventricular (Assist) Bypass

FDA Pre-Market Approval

FDA Class 3 ·HeartMate 3™ Left Ventricular Assist System (LVAS)

Hepatitis Viral B Dna Detection

FDA Pre-Market Approval

FDA Class 3 ·COMBAS AMPLIPREP/COBAS TAQMAN HBV TEST, V2.0

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

FDA Pre-Market Approval

FDA Class 3 ·DURALOC OPTION CERAMIC HIP SYSTEM

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval

FDA Class 3 ·Bausch+ Lomb Pure Vision® (balafilcon A) Visibility Tinted Soft Contact Lenses

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·ESSENTIO, PROPONENT, ACCOLADE, ALTRUA 2

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

FDA Pre-Market Approval

FDA Class 3 ·THERMOCOOL SMARTTOUCH SF BI-DIRECTIONAL & UNI-DIRECTIONAL NAVIGATION CATHETER

Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

FDA Pre-Market Approval

FDA Class 3 ·RESTORE FAMILY OF IMPLANTABLE NEUROSTIMULATORS

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval

FDA Class 3 ·Natural Eyes Hydra Wear XW and Natural Eyes XW for Astigmatism

Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval

FDA Class 3 ·ThermoCool SmartTouch Uni-directional and ThermoCool SmartTouch Bi-directional navigation Catheter

Assay, Hybridization And/Or Nucleic Acid Amplification For Detection Of Hepatitis C Rna,Hepatitis C Virus

FDA Pre-Market Approval

FDA Class 2 ·VERSANT HCV RNA 3.0 ASSAY (BDNA)

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·ENDOTAK RELIANCE LEADS

FDA Pre-Market Approval

DYNAGEN CRT-D, DYNAGEN X4 CRT-D,INOGEN CRT-D, INOGEN X4 CRT-D,ORIGEN CRT-D, ORIGEN X4 CRT-D, INCEPTA TM ICD,ENERGEN TM I

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·REVO MRI SURESCAN IPG

Hepatitis A Test (Antibody And Igm Antibody)

FDA Pre-Market Approval

FDA Class 2 ·HAVAB-M (R) EIA

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·ORIGEN EL ICD, ORIGEN MINI ICD, DYNAGEN EL ICD, DYNAGEN MINI ICD, INOGEN EL ICD, INOGEN MINI ICD, INCEPTA ICD, ENERGEN I

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·ENTOTAK LEAD SYSTEM

Device, Thermal Ablation, Endometrial

FDA Pre-Market Approval

FDA Class 3 ·Cerene® Cryotherapy Device

Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

FDA Pre-Market Approval

FDA Class 3 ·Precision Spinal Cord Stimulation SCS) System