Transcatheter Septal Occluder

FDA Pre-Market Approval

FDA Class 3 ·GORE HELEX SEPTAL OCCLUDER

Transcatheter Septal Occluder

FDA Pre-Market Approval

FDA Class 3 ·GORE HELEX SEPTAL OCCLUDER, HX2015, HX2020, HX2025, HX2030, HX2035

Catheter, Balloon, Transcervical

FDA Pre-Market Approval

FDA Class 3 ·GYNECARE THERMACHOICE III UTERINE BALLOON THERAPY SYSTEM

Drug-Eluting Sinus Stent

FDA Pre-Market Approval

FDA Class 3 ·PROPEL SINUS IMPLANT AND PROPEL MINI SINUS IMPLANT

Device, Hemostasis, Vascular

FDA Pre-Market Approval

FDA Class 3 ·PROSTAR XL 8 & 10F PVS SYSTEM

Lymph Node Location System During Sentinel Biopsy Procedure

FDA Pre-Market Approval

FDA Class 3 ·Magtrace and Sentimag Magnetic Locatization System (PUV)

Device, Hemostasis, Vascular

FDA Pre-Market Approval

FDA Class 3 ·PROSTAR 9 FR. PERCUTANEOUS VASCULAR SURGICAL (PVS) SYSTEM

Device, Hemostasis, Vascular

FDA Pre-Market Approval

FDA Class 3 ·PROSTAR 9 FR. PERCUTANEOUS VASCULAR SURGICAL (PVS) SYSTEM

Device, Hemostasis, Vascular

FDA Pre-Market Approval

FDA Class 3 ·PROSTAR 9 FR. PERCUTANEOUS VASCULAR SURGICAL (PVS) SYSTEM

Lymph Node Location System During Sentinel Biopsy Procedure

FDA Pre-Market Approval

FDA Class 3 ·Magtrace® and Sentimag® Magnetic Locatization System (PUV)

Lymph Node Location System During Sentinel Biopsy Procedure

FDA Pre-Market Approval

FDA Class 3 ·Magtrace® and Sentimag® Magnetic Locatization System (PUV)

Device, Hemostasis, Vascular

FDA Pre-Market Approval

FDA Class 3 ·PERCUTANEOUS VASCULAR CLOSURE SURGICAL (PVS) & SUTURE MEDICATED CLOSURE (SMC) SYSTEMS

Device, Hemostasis, Vascular

FDA Pre-Market Approval

FDA Class 3 ·PERCUTANEOUS VASCULAR CLOSURE SURGICAL (PVS) & SUTURE MEDICATED CLOSURE (SMC) SYSTEM

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

FDA Pre-Market Approval

FDA Class 3 ·GORE® VIABAHN® Endoprosthesis, GORE® VIABAHN® Endoprosthesis with Heparin Bioactive Surface

Lymph Node Location System During Sentinel Biopsy Procedure

FDA Pre-Market Approval

FDA Class 3 ·Magtrace/and Sentimag Magnetic Localization System

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

FDA Pre-Market Approval

FDA Class 3 ·Fluency® Plus Endovascular Stent Graft

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

FDA Pre-Market Approval

FDA Class 3 ·FLAIR ENDOVASCULAR STENT GRAFT

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

FDA Pre-Market Approval

FDA Class 3 ·BARD FLAIR ENDOVASCULAR STENT GRAFT

Lymph Node Location System During Sentinel Biopsy Procedure

FDA Pre-Market Approval

FDA Class 3 ·Magtrace and Sentimag Magnetic Localization System

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

FDA Pre-Market Approval

FDA Class 3 ·Fluency™ Endovascular Stent Graft