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

FDA Pre-Market Approval

FDA Class 3 ·CERAMAX (R) CERAMIC TOTAL HIP SYSTEM

Prosthesis, Breast, Inflatable, Internal, Saline

FDA Pre-Market Approval

FDA Class 3 ·MENTOR SPECTRUM SALINE-FILLED MAMARY PROSTHESES

Immunohistochemistry Assay, Antibody, Programmed Death-Ligand 1

FDA Pre-Market Approval

FDA Class 3 ·VENTANA PD-L1 (SP263) ASSAY

System, Laser, Transmyocardial Revascularization

FDA Pre-Market Approval

FDA Class 3 ·CARDIOGENESIS TMR 2000 HOLMIUM LASER SYSTEM

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·Evera MRI DF-I ICD/Evera MRI ICD/ Evera S DR ICD/Evera S VR ICD/ Evera XT DR ICD/ Evera XT VR ICD/ Visia AF MRI DF1 ICD/

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·Evera MRI DF-I ICD / Evera MRI ICD/ S DR ICD / S VR ICD / XT DR ICD /XT VR ICD ; Mirro MRI DR ICD / MRI VR ICD; Primo MR

Stimulator, Invasive Bone Growth

FDA Pre-Market Approval

FDA Class 3 ·EBI SPF IMPLANTABLE SPINAL FUSION STIMULATOR

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·Evera MRI DF ICD, MRI ICD, S DR ICD, S VR ICD, XT DR ICD, XT VR ICD - Visia AF MRI DFI ICD, AF MRI VR ICD, AF VR ICD

Heart-Valve, Mechanical

FDA Pre-Market Approval

FDA Class 3 ·TRIFECA HEART VALVE

Enzyme Immunoassay, Fetal Fibronectin

FDA Pre-Market Approval

FDA Class 3 ·Rapid fFN for the TLilQ System

Heart-Valve, Mechanical

FDA Pre-Market Approval

FDA Class 3 ·ST. JUDE MEDICAL MECHANICAL HEART VALVE

Heart-Valve, Mechanical

FDA Pre-Market Approval

FDA Class 3 ·EPIC VALVE

Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

FDA Pre-Market Approval

FDA Class 3 ·RESTORE,ITREL AND SYNERGY SPINAL CORD STIMULATION SYSTEMS AND PISCES,SPECIFY,AND VECTRIS SPINAL CORD STIMULATION LEADS

Stimulator, Electrical, Implanted, For Parkinsonian Tremor

FDA Pre-Market Approval

FDA Class 3 ·ACTIVA DEEP BRAIN STIMULATION THERAPY SYSTEM

Next Generation Sequencing Oncology Panel, Somatic Or Germline Variant Detection System

FDA Pre-Market Approval

FDA Class 3 ·FoundationOne CDx (FICDx)

Hepatitis Viral B Dna Detection

FDA Pre-Market Approval

FDA Class 3 ·cobas HBV Test

Hepatitis Viral B Dna Detection

FDA Pre-Market Approval

FDA Class 3 ·ABBOTT REALTIME HBV

Hepatitis Viral B Dna Detection

FDA Pre-Market Approval

FDA Class 3 ·COBAS HBV TEST

Kit, Dna Detection, Human Papillomavirus

FDA Pre-Market Approval

FDA Class 3 ·DIGENE HC2 SYSTEM SOFTWARE

Hepatitis Viral B Dna Detection

FDA Pre-Market Approval

FDA Class 3 ·COBAS TAQMAN HBV TEST FOR USE WITH THE HIGH PURE SYSTEM/COBAS AMPLIPREP/COBAS TAQMAN HBV TEST