Heart-Valve, Non-Allograft Tissue

FDA Pre-Market Approval

FDA Class 3 ·Edwards Pericardial Aortic Bioprosthesis (RESILIA tissue)

Replacement Heart-Valve

FDA Pre-Market Approval

FDA Class 3 ·Carpentier-Edwards PERIMOUNT Pericardial Aortic Bioprosthesis; Theon Pericardial Aortic Bioprosthesis with ThermaFix tis

Heart-Valve, Non-Allograft Tissue

FDA Pre-Market Approval

FDA Class 3 ·EDWARDS INTUITY ELITE Valve System

Sealant, Polymerizing

FDA Pre-Market Approval

FDA Class 3 ·PROGEL PLEURAL AIR LEAK SEALANT

Defibrillator, Implantable, Dual-Chamber

FDA Pre-Market Approval

FDA Class 3 ·LEXOS DR/VR(-T) ICDS & LUMOS VR/DR (-T) & XELOS DR-T ICD & BELOS DR (-T) ICDS

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·CARDIAC AIRBAG (-T) ICDS & BELOS VR (-T) ICDS & TMS 1000 PLUS PROGRAMMING SYSTEM

Defibrillator, Implantable, Dual-Chamber

FDA Pre-Market Approval

FDA Class 3 ·KRONOS LV-T CRT-D & LUMAX VR/DR/HF (-T) ICDS & CDT-DS

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·CYLOS PACEMAKER & PHILOS II PACEMAKERS & ICS 3000 IMPLANT CONTROL SYSTEM & IMPLANT MODULE

Heart-Valve, Mechanical

FDA Pre-Market Approval

FDA Class 3 ·MECHANICAL HEART VALVE SJM(R) MASTER SERIES

Intrasaccular Flow Disruption Device

FDA Pre-Market Approval

FDA Class 3 ·Woven EndoBridge (WEB) Aneurysm Embolization System

Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval

FDA Class 3 ·CCT.2 CRYOABLATION CONSOLE SYSTEM

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·SENSAR 1-Piece IOL with Smart LOAD Delivery Technology, TECNIS 1-Piece IOL with Smart LOAD Delivery Technology, TECNIS O

Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)

FDA Pre-Market Approval

FDA Class 3 ·Elecsys HBsAg II, Elecsys HBsAg Confirmatory Test, and PreciControl HBsAg II

Imager, Breast, Electrical Impedance

FDA Pre-Market Approval

FDA Class 3 ·T-SCAN 2000

Imager, Breast, Electrical Impedance

FDA Pre-Market Approval

FDA Class 3 ·TS2000

Imager, Breast, Electrical Impedance

FDA Pre-Market Approval

FDA Class 3 ·TRANSCAN T-SCAN 2000

Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)

FDA Pre-Market Approval

FDA Class 3 ·Elecsys Anti-HBc Immunoassay test system

Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)

FDA Pre-Market Approval

FDA Class 3 ·Elecsys Anti-HBC Immunoassay test system

Processor, Cervical Cytology Slide, Automated

FDA Pre-Market Approval

FDA Class 3 ·PRESERVCYT SOLUTION ALTERNATIVE TRANSPORT MEDIUM

Stimulator, Bone Growth, Non-Invasive

FDA Pre-Market Approval

FDA Class 3 ·ORTHOPAK(R) BONE GROWTH STIMULATOR