Somatic Gene Mutation Detection System

FDA Pre-Market Approval

FDA Class 3 ·therascreen BRAF V600E RGQ PCR Kit

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·Tendril MRI, Assurity MRI, Endurity MRI family of Pacemakers

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·Durata, Optisure

Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P)

FDA Pre-Market Approval

FDA Class 3 ·Anthem, Allure/RF, Allure Quadra/RF family of CRT-Ps

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·Current, Current Accel, Current+, Ellipse, Fortify, Fortify Assura, Epic/Epic+, Atlas/II/+ family of ICDs

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

FDA Pre-Market Approval

FDA Class 3 ·Avant™ HF, Neutrino™ NxT HF, Gallant ™ HF, Entrant™ HF, Promote/+/RF/Q, Promote Accel, Promote Quadra, Unify, Unify Assu

Pulse-Generator, Single Chamber, Sensor Driven, Implantable

FDA Pre-Market Approval

FDA Class 3 ·Microny family of Pacemakers

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

FDA Pre-Market Approval

FDA Class 3 ·Tendril STS, UltiPace

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval

FDA Class 3 ·Assurity, Assurity+, Endurity, Accent family of Pacemakers

Leadless Pacemaker

FDA Pre-Market Approval

FDA Class 3 ·Aveir Leadless System

Somatic Gene Mutation Detection System

FDA Pre-Market Approval

FDA Class 3 ·therascreen PDGFRA RGQ PCR Kit

Somatic Gene Mutation Detection System

FDA Pre-Market Approval

FDA Class 3 ·THERASCREEN KRAS RGQ PCR KIT

Filler, Recombinant Human Bone Morphogenetic Protein, Collagen Scaffold With Metal Prosthesis, Osteoinduction

FDA Pre-Market Approval

FDA Class 3 ·INFUSE™ Bone Graft/Medtronic Interbody Fusion Device

Filler, Recombinant Human Bone Morphogenetic Protein, Collagen Scaffold, Osteoinduction

FDA Pre-Market Approval

FDA Class 3 ·INFUSE™ Bone Graft

Bone Grafting Material, Dental, With Biologic Component

FDA Pre-Market Approval

FDA Class 3 ·INFUSE™ Bone Graft

Somatic Gene Mutation Detection System

FDA Pre-Market Approval

FDA Class 3 ·THERASCREEN KRAS RGQ PCR KIT

Somatic Gene Mutation Detection System

FDA Pre-Market Approval

FDA Class 3 ·therascreen EGFR RGQ PCR Kit

Somatic Gene Mutation Detection System

FDA Pre-Market Approval

FDA Class 3 ·therascreen FGFR RGQ PCR Kit

Somatic Gene Mutation Detection System

FDA Pre-Market Approval

FDA Class 3 ·THERASCREEN EGFR RGQ PCR KIT

Somatic Gene Mutation Detection System

FDA Pre-Market Approval

FDA Class 3 ·THERASCREEN KRAS RGQ PCR KIT