Immunohistochemistry Assay, Antibody, Met

FDA Pre-Market Approval

FDA Class 3 ·VENTANA MET (SP44) RxDx Assay

Immunohistochemistry Assay, Antibody, Met

FDA Pre-Market Approval

FDA Class 3 ·VENTANA MET (SP44) RxDx Assay

Covered Stent Vascular Connector, Hemodialysis Access Circuit

FDA Pre-Market Approval

FDA Class 3 ·EndoForce™ Connector for Endovascular Venous Anastomosis

Leadless Cardiac Resynchronization Therapy (Crt)

FDA Pre-Market Approval

FDA Class 3 ·WiSE® (Wireless Stimulation of the Endocardium Technology) CRT System

Covered Stent Vascular Connector, Hemodialysis Access Circuit

FDA Pre-Market Approval

FDA Class 3 ·EndoForce Connector for Endovascular Venous Anastomosis

Immunohistochemistry Assay, Antibody, Met

FDA Pre-Market Approval

FDA Class 3 ·VENTANA MET (SP44) RxDx Assay

Leadless Cardiac Resynchronization Therapy (Crt)

FDA Pre-Market Approval

FDA Class 3 ·WiSE® (Wireless Stimulation of the Endocardium Technology) CRT System

Stent, Carotid

FDA Pre-Market Approval

FDA Class 3 ·Neuroguard IEP® 3-in-1 Carotid Stent, Post-Dilation Balloon System with Integrated Embolic Protection

Stent, Carotid

FDA Pre-Market Approval

FDA Class 3 ·Neuroguard IEP® 3-in-1 Carotid Stent, Post-Dilatation Balloon System with Integrated Embolic Protection

Stent, Carotid

FDA Pre-Market Approval

FDA Class 3 ·Neuroguard IEP 3-in-1 Carotid Stent and Post-Dilation Balloon System with Integrated Embolic Protection

Device, Hemostasis, Vascular

FDA Pre-Market Approval

FDA Class 3 ·FEMORAL INTRODUCER SHEATH & HEMOSTASIS DEVICE (FISH)

System, Endovascular Graft, Aortic Aneurysm Treatment

FDA Pre-Market Approval

FDA Class 3 ·GORE TAG Thoracic Endoprosthesis and GORE TAG Conformable Thoracic Stent Graft with ACTIVE CONTROL System

System, Endovascular Graft, Aortic Aneurysm Treatment

FDA Pre-Market Approval

FDA Class 3 ·GORE EXCLUDER Iliac Branch Endoprosthesis

CARDIOVASCULAR PERMANENT PACEMAKER ELECTRODE

FDA 510(k)

FDA Class 3 ·Cardiovascular

MEDTRONIC MODELS 4057M,4058M,4557M, PACING LEADS

FDA 510(k)

FDA Class 3 ·Cardiovascular

PIKOS LP 01, PIKOS LP E01

FDA 510(k)

FDA Class 3 ·Cardiovascular

PACEMAKER, MODEL DDP ELECTRONIC CIRCUIT

FDA 510(k)

FDA Class 3 ·Cardiovascular

MEDTRONIC MODEL 4558M

FDA 510(k)

FDA Class 3 ·Cardiovascular

MEDTRONIC MODELS 5069 AND 5071 MYOCARDIAL PACING

FDA 510(k)

FDA Class 3 ·Cardiovascular

PIKOS E 01-B

FDA 510(k)

FDA Class 3 ·Cardiovascular