Implant, Cochlear

FDA Pre-Market Approval

FDA Class 3 ·HIRESOLUTION BIONIC EAR SYSTEM

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval

FDA Class 3 ·MODEL 9790C PROGRAMMER AND MODEL 9891 PE SOFTWARE

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval

FDA Class 3 ·Edora 8 DR-T, Evity 8 DR-T, Enitra 8 DR-T, Enticos 8 DR-T, Evity 6 DR-T, Enitra 6 DR-T, Edora 8 DR, Enitra 6 DR, Enticos

Next Generation Sequencing Oncology Panel, Somatic Or Germline Variant Detection System

FDA Pre-Market Approval

FDA Class 3 ·FoundationOne CDx (FICDx)

Immunohistochemistry Test, Dna Mismatch Repair (Mmr) Protein Assay

FDA Pre-Market Approval

FDA Class 3 ·VENTANA MMR RxDx Panel

Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Ceramic/Metal, Cemented Or Uncemented

FDA Pre-Market Approval

FDA Class 3 ·Transcend® Hip Articulation System

Implant, Cochlear

FDA Pre-Market Approval

FDA Class 3 ·NUCLEUS 22 CHANNEL COCHLEAR IMPLANT

Implant, Cochlear

FDA Pre-Market Approval

FDA Class 3 ·NUCLEUS 22 CHANNEL COCHLEAR IMPLANT SYSTEM

Sealant, Dural

FDA Pre-Market Approval

FDA Class 3 ·DuraSeal Exact Spine Sealant System

Sealant, Dural

FDA Pre-Market Approval

FDA Class 3 ·DuraSeal Dural Sealant System

Automated External Defibrillators (Non-Wearable)

FDA Pre-Market Approval

FDA Class 3 ·LIFEPAK® 1000 Defibrillator

Automated External Defibrillators (Non-Wearable)

FDA Pre-Market Approval

FDA Class 3 ·HeartSine’s Samaritan® Public Access Automated External Defibrillators

Automated External Defibrillators (Non-Wearable)

FDA Pre-Market Approval

FDA Class 3 ·LIFEPAK® 35 Monitor/Defibrillator

Automated External Defibrillators (Non-Wearable)

FDA Pre-Market Approval

FDA Class 3 ·X Series, Propaq MD

Automated External Defibrillators (Non-Wearable)

FDA Pre-Market Approval

FDA Class 3 ·CPR-D-padz One-Piece Electrode Pad with Real CPR Help, OneStep CPR Complete Electrode, Pro-padz Biphasic Electrode, Pro-

Automated External Defibrillators (Non-Wearable)

FDA Pre-Market Approval

FDA Class 3 ·HeartStart FRx Defibrillator

Automated External Defibrillators (Non-Wearable)

FDA Pre-Market Approval

FDA Class 3 ·HeartSine'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 ·LIFEPAK CR2 Automated External Defibrillator

Catheter, Balloon, Transcervical

FDA Pre-Market Approval

FDA Class 3 ·GYNECARE THERMACHOICE III UTERINE BALLOON THERAPY SYSTEM

Automated External Defibrillators (Non-Wearable)

FDA Pre-Market Approval

FDA Class 3 ·LIFEPAK Automated External Defibrillator (AED)