Cancer-Related Germline Gene Mutation Detection System

FDA Pre-Market Approval

FDA Class 3 ·myChoice HRD CDx

Cancer-Related Germline Gene Mutation Detection System

FDA Pre-Market Approval

FDA Class 3 ·myChoice HRD CDx

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·CARELINK PROGRAMMER CRM PROGRAMMER

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

FDA Pre-Market Approval

FDA Class 3 ·FoundationFocus CDx BRCA HRD

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval

FDA Class 3 ·Reply/Esprit Pacemakers Sorin CRM.

Mitral Valve Repair Devices

FDA Pre-Market Approval

FDA Class 3 ·MitraClip NT, NTR, XTR, G4 Clip Delivery System

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

FDA Pre-Market Approval

FDA Class 3 ·R3 DELTA CERAMIC HIP SYSTEM

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

FDA Pre-Market Approval

FDA Class 3 ·Platinium CRT-Ds (Cardiac Resynchronization Therapy-Defibrillator)

Defibrillator, Implantable, Dual-Chamber

FDA Pre-Market Approval

FDA Class 3 ·Platinium VR and Platinium DR ICD's (Implantable Cardioverter Defobrillator)

Excimer Laser System

FDA Pre-Market Approval

FDA Class 3 ·iDesign Refractive Studio

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·Softec HD/ HD PS, Softec I, Softec HDO, Softec HDM IOLs

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·Softec HD, Sotlec I, Softec HD PS, Softec HDO, Softec HDM

DEPUY PINNACLE METAL-ON-METAL ACETABULAR CUP LINER

FDA 510(k)

FDA Class 3 ·Orthopedic

Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled

FDA Pre-Market Approval

FDA Class 3 ·NATRELLE Silicone-Filled Breast Implants

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·HQL Softec HD, Softec I, Softec HD PS, Softec HDO, Softec HDM

Mitral Valve Repair Devices

FDA Pre-Market Approval

FDA Class 3 ·MitraClip G4 System

Coronary Drug-Eluting Stent

FDA Pre-Market Approval

FDA Class 3 ·Resolute Onyx RX Zotarolimus-Eluting Coronary Stent System, Resolute Onyx OTW Zotarolimus-Eluting Coronary Stent System,

Mitral Valve Repair Devices

FDA Pre-Market Approval

FDA Class 3 ·MITRACLIP NT CLIP DELIVER SYSTEM

Ablation Catheter, Renal Denervation

FDA Pre-Market Approval

FDA Class 3 ·ReCor Paradise® Ultrasound Renal Denervation System

Automated Insulin Dosing , Threshold Suspend

FDA Pre-Market Approval

FDA Class 3 ·MiniMed 630G System