Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled

FDA Pre-Market Approval

FDA Class 3 ·Sientra OPUS Silicone Gel Breast Implants

Intracranial Aneurysm Flow Diverter

FDA Pre-Market Approval

FDA Class 3 ·Pipeline™ Flex Embolization Device with Shield Technology™, Pipeline™ Vantage Embolization Device with Shield Technology

Implant, Hearing, Active, Middle Ear, Totally Implanted

FDA Pre-Market Approval

FDA Class 3 ·ESTEEM

Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval

FDA Class 3 ·BOSTON SCIENTIFIC XP APM (AUTOMATIC PERSONALITY MODULE) UNIT, MODEL 822T

Device, Impotence, Mechanical/Hydraulic

FDA Pre-Market Approval

FDA Class 3 ·TITAN INFLATABLE PENILE PROSTHESIS

Device, Impotence, Mechanical/Hydraulic

FDA Pre-Market Approval

FDA Class 3 ·TITAN INFLATABLE PENILE PROSTHESIS

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval

FDA Class 3 ·OCUFILCON D SPHERICAL AND TORIC EXTENDED WEAR CONTACT LENSES

ZOLL M SERIES ETCO2 OPTION

FDA 510(k)

FDA Class 3 ·Cardiovascular

ZOLL PAD WITH CPR AID

FDA 510(k)

FDA Class 3 ·Cardiovascular

ZOLL M SERIES WITH RECTILINEAR BI-PHASIC OPTION (M SERIES BI-PHASIC)

FDA 510(k)

FDA Class 3 ·Cardiovascular

ZOLL M SERIES

FDA 510(k)

FDA Class 3 ·Cardiovascular

ZOLL AED PLUS

FDA 510(k)

FDA Class 3 ·Cardiovascular

ZOLL PAD

FDA 510(k)

FDA Class 3 ·Cardiovascular

ZOLL M SERIES 12SL ANALYSIS OPTION

FDA 510(k)

FDA Class 3 ·Cardiovascular

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

FDA Pre-Market Approval

FDA Class 3 ·Guardant360 CDx

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

FDA Pre-Market Approval

FDA Class 3 ·TactiCath™ Contact Force Ablation Catheter, Sensor Enabled™

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

FDA Pre-Market Approval

FDA Class 3 ·Guardant360 CDx

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·CAPSURE VDD LEADS/VITATRON LEGACY DR/D/II/VISA/CAPSURE LEAD/BRILLIANT S+VDD

Ligaments And Tendons, Synthetic

FDA Pre-Market Approval

FDA Class 3 ·STRKYER KNEE AUGMENTATION GRAFT

Immunohistochemistry Antibody Assay, C-Kit

FDA Pre-Market Approval

FDA Class 3 ·VENTANA PATHWAY ANTI-C-KIT PRIMARY ANTIBODY (POLYCLONAL)