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

FDA Pre-Market Approval

FDA Class 3 ·GORE VIABAHN ENDOPROSTHESIS

Transcatheter Septal Occluder

FDA Pre-Market Approval

FDA Class 3 ·GORE HELEX SEPTAL OCCLUDER

System, Endovascular Graft, Aortic Aneurysm Treatment

FDA Pre-Market Approval

FDA Class 3 ·GORE TAG THORACIC ENDOPROSTHESIS

Shunt, Portosystemic, Endoprosthesis

FDA Pre-Market Approval

FDA Class 3 ·GORE VIATORR TIPS ENDOPROSTHESIS

Stent, Superficial Femoral Artery

FDA Pre-Market Approval

FDA Class 3 ·GORE VIABAHN ENDOPROSTHESIS

System, Endovascular Graft, Aortic Aneurysm Treatment

FDA Pre-Market Approval

FDA Class 3 ·GORE EXCLUDER AAA ENDOPROSTHESIS

SPINAL STABILIZING SPHERE SYSTEM

FDA 510(k)

FDA Class 3 ·Unknown

SPINAL SPHERES

FDA 510(k)

FDA Class 3 ·Unknown

SATELLITE SPINAL SYSTEM

FDA 510(k)

FDA Class 3 ·Unknown

PEEK SPINAL SPHERES

FDA 510(k)

FDA Class 3 ·Unknown

MODIFICATION TO: SATELLITE SPINAL SYSTEM

FDA 510(k)

FDA Class 3 ·Unknown

SPINAL SPHERE SYSTEM

FDA 510(k)

FDA Class 3 ·Unknown

Intervertebral Fusion Device With Bone Graft, Solid-Sphere, Lumbar

FDA classification

FDA Class 3 ·Intervertebral Fusion Device With Bone Graft, Solid-Sphere, Lumbar

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·VARIOUS MODELS OF IPG'S: ACTROS, AXIOS, CYLOS, DROMOS, KAIROS, PHILOS/II, PROTOS, ETC.

Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P)

FDA Pre-Market Approval

FDA Class 3 ·STRATOS LV/LV-T, EVIA AND ENTOVIS HF/HF-T CRT-P'S

Defibrillator, Implantable, Dual-Chamber

FDA Pre-Market Approval

FDA Class 3 ·ILESTO 7/ 5 VR-T ICD, IFORIA 7/ 5 VR-T ICD, ILESTO 7/ 5 VR-T DX ICD, ILFORIA 7/ 5 VR-T DX ICD, ILESTO 7/ 5 DR-T ICD

Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D)

FDA Pre-Market Approval

FDA Class 3 ·BELOS & LEXOS DR/DR-T/VR/VR-T, LUMOS DR-T/VR-T, XELOS DR-T ICD'S

Defibrillator, Implantable, Dual-Chamber

FDA Pre-Market Approval

FDA Class 3 ·Acticor 7 VR-T / Rivacor 7 VR-T /5VR-T /3 VR-T / Acticor 7 VR-T DX / Rivacor 7 VR-T DX /Rivacor 5 VR-T DX ; Acticor 7 DR

Defibrillator, Implantable, Dual-Chamber

FDA Pre-Market Approval

FDA Class 3 ·Inlexa 7 VR-T, Inlexa 3 VR-T, Llivia 7 VR-T, Intica 7 VR-T, Intica 5 VR-T, Iperia 7 VR-T, Itrevia 5 VR-T, Inventra 7 VR-

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·Acticor 7 VR-T, Rivacor 7 VR-T, Rivacor 5 VR, -T, Rivacor 3 VR-T, Acticor 7 VR-T DX, Rivacor 7 VR-T DX, Rivacor 5 VR-T D