Stent, Coronary

FDA Pre-Market Approval

FDA Class 3 ·COBRA PzF NanoCoated Coronary Stent System

Stent, Coronary

FDA Pre-Market Approval

FDA Class 3 ·COBRA PzF NanoCoated Coronary Stent System

Stent, Coronary

FDA Pre-Market Approval

FDA Class 3 ·COBRA PzF NanoCoated Coronary Stent System

Stent, Coronary

FDA Pre-Market Approval

FDA Class 3 ·COBRA PzF NanoCoated Coronary Stent System

Stent, Coronary

FDA Pre-Market Approval

FDA Class 3 ·COBRA PzF NanoCoated Coronary Stent System

Stent, Coronary

FDA Pre-Market Approval

FDA Class 3 ·COBRA PzF NanoCoated Coronary Stent System

Mr-Guided Focused Ultrasound System

FDA Pre-Market Approval

FDA Class 3 ·Exablate Model 4000 Type 1.0 and 1.1 System (“Exablate Neuro”)

Mr-Guided Focused Ultrasound System

FDA Pre-Market Approval

FDA Class 3 ·Exablate Model 4000 System Type 1.0 and 1.1 System (“Exablate Neuro”; “Exablate Prime”)

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval

FDA Class 3 ·PK-175/2,3m Patient Cable, PK-83, 2.5m

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval

FDA Class 3 ·PK-222 and PK-Electrode Clip (accessory to Renamic)

Drug Eluting Permanent Right Ventricular (Rv) Or Right Atrial (Ra) Pacemaker Electrodes

FDA Pre-Market Approval

FDA Class 3 ·FNLN2 SXP BP, FNLN2 SXP PF BP, FNLN2 SX PF BP, FNLN2 SXP J BP,

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·LD SEN DF4 IB IR PF DC, LD SEN DF4 IB IR PF SC, LD SEN DF4 IB IR PF SC, LD SEN DF4 IB IR PF DC, LD SEN DF4 IB IR AF SC,

Immunohistochemistry Assay, Antibody, Anaplastic Lymphoma Kinase

FDA Pre-Market Approval

FDA Class 3 ·VENTANA ALK (D5F3) CDx Assay

Immunohistochemistry Antibody Assay, C-Kit

FDA Pre-Market Approval

FDA Class 3 ·PATHWAY ANTI-C-KIT (9.7) RABBIT MONOCLONAL PRIMARY ANTIBODY

Immunohistochemistry Antibody Assay, C-Kit

FDA Pre-Market Approval

FDA Class 3 ·PATHWAY ANTI-C-KIT (9.7) REBBIT MONOCLONAL PRIMARY ANTIBODY

Immunohistochemistry Antibody Assay, C-Kit

FDA Pre-Market Approval

FDA Class 3 ·PATHWAY ANTI-C-KIT (9.7) RABBITT MONOCLONAL PRIMARY ANTOBODY

Immunohistochemistry Antibody Assay, C-Kit

FDA Pre-Market Approval

FDA Class 3 ·PATHWAY ANTI-C-KIT (9.7) PRIMARY ANTIBODY

Immunohistochemistry Antibody Assay, C-Kit

FDA Pre-Market Approval

FDA Class 3 ·DAKO C-KIT PHARMDX

Immunohistochemistry Assay, Antibody, Anaplastic Lymphoma Kinase

FDA Pre-Market Approval

FDA Class 3 ·VENTANA ALK (D5F3) CDx Assay

Immunohistochemistry Antibody Assay, C-Kit

FDA Pre-Market Approval

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