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

FDA Pre-Market Approval

FDA Class 3 ·FINELINE® II Sterox, FINELINE® II EZ Sterox, ACC SUP STABLZR 6220 US, ACC SUP STABLZR 6221 US

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval

FDA Class 3 ·UNITY - C MODEL 292-06 PULSE GENERATOR & ACCS.

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval

FDA Class 3 ·PHILOS DR ACC PACING SYSTEM AND PROGRAMMER SOFTWARE VERSION B-KAC.V.U/1

Permanent Defibrillator Electrodes

FDA Pre-Market Approval

FDA Class 3 ·SELECTSECURE 3830

Occluder, Internal Vessel, Temporary

FDA Pre-Market Approval

FDA Class 3 ·LEGOO

Transurethral Occlusion Insert, Urinary Incontinence-Control, Female

FDA Pre-Market Approval

FDA Class 3 ·FEMSOFT URETHRAL INSERT

Rt-Pcr Multigene Expression Test, Sentinel Lymph Node, Cancer Metastasis Detection

FDA Pre-Market Approval

FDA Class 3 ·GENESEARCH BREAST LYMPH NODE ASSAY

Transurethral Occlusion Insert, Urinary Incontinence-Control, Female

FDA Pre-Market Approval

FDA Class 3 ·RELIANCE URINARY CONTROL INSERT & SIZING DEVICE

Occluder, Internal Vessel, Temporary

FDA Pre-Market Approval

FDA Class 3 ·LEGOO ENDOVASCULAR OCCLUSION GEL

Occluder, Internal Vessel, Temporary

FDA Pre-Market Approval

FDA Class 3 ·LEGOO ENDOVASCULAR OCCLUDER

Transurethral Occlusion Insert, Urinary Incontinence-Control, Female

FDA Pre-Market Approval

FDA Class 3 ·FEMSOFT URETHRAL INSERT

Occluder, Internal Vessel, Temporary

FDA Pre-Market Approval

FDA Class 3 ·LEGOO

Transurethral Occlusion Insert, Urinary Incontinence-Control, Female

FDA Pre-Market Approval

FDA Class 3 ·RELIANCE URINARY CONTROL INSERT AND SIZING DEVICE

Transurethral Occlusion Insert, Urinary Incontinence-Control, Female

FDA Pre-Market Approval

FDA Class 3 ·FEMSOFT URETHRAL INSERT

Rt-Pcr Multigene Expression Test, Sentinel Lymph Node, Cancer Metastasis Detection

FDA Pre-Market Approval

FDA Class 3 ·GENESEARCH BREAST LYMPH NODE

Rt-Pcr Multigene Expression Test, Sentinel Lymph Node, Cancer Metastasis Detection

FDA Pre-Market Approval

FDA Class 3 ·GENESEARCH BREAST LYMPH NODE (BLN) ASSAY

Occluder, Internal Vessel, Temporary

FDA Pre-Market Approval

FDA Class 3 ·LEGOO

Rt-Pcr Multigene Expression Test, Sentinel Lymph Node, Cancer Metastasis Detection

FDA Pre-Market Approval

FDA Class 3 ·GENESEARCH BREAST LYMPH NODE(BLN) ASSAY

System, Endovascular Graft, Aortic Aneurysm Treatment

FDA Pre-Market Approval

FDA Class 3 ·Endurant Stent Graft System, Endurant II Stent Graft System, Endurant II AUI Stent Graft System, Talent Endoluminal Occl

Organ Care System (Ocs) Heart System

FDA Pre-Market Approval

FDA Class 3 ·Organ Care System (OCS) Heart