System, Endovascular Graft, Aortic Aneurysm Treatment

FDA Pre-Market Approval

FDA Class 3 ·ZENITH TX2 THORACIC TAA ENDOVASCULAR GRAFT WITH THE H&LB ONE-SHOT INTRODUCTION SYSTEM

System, Endovascular Graft, Aortic Aneurysm Treatment

FDA Pre-Market Approval

FDA Class 3 ·Zenith® Dissection Endovascular System

System, Endovascular Graft, Aortic Aneurysm Treatment

FDA Pre-Market Approval

FDA Class 3 ·Zenith Dissection Endovascular System

System, Endovascular Graft, Aortic Aneurysm Treatment

FDA Pre-Market Approval

FDA Class 3 ·ZENITH TX2 TAA ENDOVASCULAR GRAFT

System, Endovascular Graft, Aortic Aneurysm Treatment

FDA Pre-Market Approval

FDA Class 3 ·Zenith Dissection Endovascular System

Automated External Defibrillators (Non-Wearable)

FDA Pre-Market Approval

FDA Class 3 ·QUIK-PAK Electrodes

Occluder, Patent Ductus, Arteriosus

FDA Pre-Market Approval

FDA Class 3 ·NIT-OCCLUD PDA

Automated External Defibrillators (Non-Wearable)

FDA Pre-Market Approval

FDA Class 3 ·QUIK-PAK™ Electrodes

Occluder, Patent Ductus, Arteriosus

FDA Pre-Market Approval

FDA Class 3 ·NIT-OCCLUD PDA

Occluder, Patent Ductus, Arteriosus

FDA Pre-Market Approval

FDA Class 3 ·NIT-OCCLUD PDA

Automated External Defibrillators (Non-Wearable)

FDA Pre-Market Approval

FDA Class 3 ·QUIK-PAK Electrodes

Occluder, Patent Ductus, Arteriosus

FDA Pre-Market Approval

FDA Class 3 ·PMA NIT-OCCLUD PDA

Automated External Defibrillators (Non-Wearable)

FDA Pre-Market Approval

FDA Class 3 ·samaritan® PAD 350P (SAM 350P), samaritan® PAD 360P (SAM 360P), samaritan® PAD 450P (SAM 450P), Pad-Paks (Adult, Pediatr

Automated External Defibrillators (Non-Wearable)

FDA Pre-Market Approval

FDA Class 3 ·samaritan Public Access Automated External Defibrillators and Accessories

Automated External Defibrillators (Non-Wearable)

FDA Pre-Market Approval

FDA Class 3 ·HeartSine Technologies LLC's samaritan Public Access Automated External Defibrillators (SAM 350P, SAM 360P and SAM 450P)

Automated External Defibrillators (Non-Wearable)

FDA Pre-Market Approval

FDA Class 3 ·HeartSine Technologies LLC's samaritan Public Access Automated External Defibrillators (SAM 350P, SAM 360P and SAM 450P)

Automated External Defibrillators (Non-Wearable)

FDA Pre-Market Approval

FDA Class 3 ·HeartSine samaritan® Public Access Automated External Defibrillators and Accessories

Implant, Cochlear

FDA Pre-Market Approval

FDA Class 3 ·CLARION CII BIONIC EAR SYSTEM (ADULT)

Implant, Cochlear

FDA Pre-Market Approval

FDA Class 3 ·CLARION CII BIONIC EAR SYSTEM (PEDIATRIC)

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

FDA Pre-Market Approval

FDA Class 3 ·VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBC IGM REAGENT PAK/CALIBRATOR