Somatic Gene Mutation Detection System

FDA Pre-Market Approval

FDA Class 3 ·LeukoStrat CDx FLT3 Mutation Assay

Coronary Drug-Eluting Stent

FDA Pre-Market Approval

FDA Class 3 ·EluNIR™ Ridaforolimus Eluting Coronary Stent System

Ventricular (Assist) Bypass

FDA Pre-Market Approval

FDA Class 3 ·HeartWare Left Ventricular Assist System

Stent, Coronary

FDA Pre-Market Approval

FDA Class 3 ·MICRO STENT TM II, MICRO STENT TM II XL, GFX TM, GFX TM XL

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·S-ICD Battery Anode Laser Edge Weld Process

Lipoprotein, Low Density, Removal

FDA Pre-Market Approval

FDA Class 3 ·Heparin_Induced Extracorporeal LDL Precipitation (H.E.L.P.) Futura Apheresis System

System, Endovascular Graft, Arteriovenous (Av) Dialysis Access Circuit Stenosis Treatment

FDA Pre-Market Approval

FDA Class 3 ·GORE VIABAHN Endoprosthesis with Heparin Bioactive Surface

Stent, Superficial Femoral Artery

FDA Pre-Market Approval

FDA Class 3 ·GORE VIABAHN Endoprosthesis

Lipoprotein, Low Density, Removal

FDA Pre-Market Approval

FDA Class 3 ·PLASMAT SECURA HEPARIN-INDUCED EXTRACORPOREAL LDL APHERESIS SYSTEM (H.E.L.P.)

Light Adjustable Lens (Lal) And Light Delivery Device (Ldd)

FDA Pre-Market Approval

FDA Class 3 ·Light Adjustable Lens (LAL), Light Delivery Device (LDD) System

Light Adjustable Lens (Lal) And Light Delivery Device (Ldd)

FDA Pre-Market Approval

FDA Class 3 ·LIGHT ADJUSTABLE LENS (LAL) AND LIGHT DELIVERY DEVICE (LDD)

Lipoprotein, Low Density, Removal

FDA Pre-Market Approval

FDA Class 3 ·HEPARIN-INDUCED EXTRACORPOREAL LDL PRECIPITATION (H.E.L.P.)FUTURA APHERESIS SYSTEM

Light Adjustable Lens (Lal) And Light Delivery Device (Ldd)

FDA Pre-Market Approval

FDA Class 3 ·Light Adjustable Lens (LAL) and Light Delivery Device (LDD)

Light Adjustable Lens (Lal) And Light Delivery Device (Ldd)

FDA Pre-Market Approval

FDA Class 3 ·Light Adjustable Lens (LAL) and Light Delivery Device (LDD)

Light Adjustable Lens (Lal) And Light Delivery Device (Ldd)

FDA Pre-Market Approval

FDA Class 3 ·RxSight Light Adjustable Lens (LAL), Light Delivery Device (LDD)

Lipoprotein, Low Density, Removal

FDA Pre-Market Approval

FDA Class 3 ·Heparin-Induced Extracorporeal LDL Precipitation (H.E.L.P.) Futura Apheresis System

Light Adjustable Lens (Lal) And Light Delivery Device (Ldd)

FDA Pre-Market Approval

FDA Class 3 ·Light Adjustable Lens (LAL) and Light Delivery Device (LDD)

Lipoprotein, Low Density, Removal

FDA Pre-Market Approval

FDA Class 3 ·HEPARIN-INDUCED EXTRACORPOREAL LDL PRECIPITATION (H.E.L.P.) FUTURA APHERESIS SYSTEM

Lipoprotein, Low Density, Removal

FDA Pre-Market Approval

FDA Class 3 ·Heparin-Induced Extracorporeal LDL Precipitation (H.E.L.P.) Futura Apheresis System

Lipoprotein, Low Density, Removal

FDA Pre-Market Approval

FDA Class 3 ·HEPARIN-INDUCED EXTRACORPOREAL LDL-PRECIPITATION (H.E.L.P.) FUTURA APHERESIS SYSTEM