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

FDA Pre-Market Approval

FDA Class 3 ·FoundationOne CDx (F1CDx)

Prosthesis, Intervertebral Disc

FDA Pre-Market Approval

FDA Class 3 ·PRESTIGE LP(TM) CERVICAL DISC

Stent, Iliac

FDA Pre-Market Approval

FDA Class 3 ·COMPLETE SE VASCULAR STENT SYSTEM

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·MODEL 6577 STERILIZABLE TELEMETRY WAND

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·DIPLOS MODEL 03

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

FDA Pre-Market Approval

FDA Class 3 ·CareLink SmartSync Cobalt, Crome App

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·CADENCE(R) TIERED THERAPY DEFIBRILLATION SYSTEM

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·POSTERIOR CHAMBER INTRAOCULAR LENSES

Stimulator, Bone Growth, Non-Invasive

FDA Pre-Market Approval

FDA Class 3 ·SPINAL-STIM SPINAL FUSION SYSTEM

Coronary Drug-Eluting Stent

FDA Pre-Market Approval

FDA Class 3 ·Orsiro Sirolimus Eluting Coronary Stent System

Device, Hemostasis, Vascular

FDA Pre-Market Approval

FDA Class 3 ·Cardiva VASCADE Vascular Closure System (VCS)

Automated External Defibrillators (Non-Wearable)

FDA Pre-Market Approval

FDA Class 3 ·LIFEPAK Automated External Defibrillator (AED)

Heart-Valve, Mechanical

FDA Pre-Market Approval

FDA Class 3 ·On-X Prosthetic Heart Valve and On-X Ascending Aortic Prosthesis devices

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

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

Stimulator, Bone Growth, Non-Invasive

FDA Pre-Market Approval

FDA Class 3 ·OL1000/OL1000 SC/SPINALOGIC BONE GROWTH STIMULATORS

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·CADENCE(R) TIERED THERAPY DEFIBRILLATOR SYSTEM

Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval

FDA Class 3 ·SmartAblate System Foot Pedal.

Device, Angioplasty, Laser, Coronary

FDA Pre-Market Approval

FDA Class 3 ·8 ECTRAPROBE-PLR MODEL 900 OPTILASE CONTACT LASER

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·PROTECTS XT VR, PROTECTA VR, SECURA VR MAXIMO II ICD

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·AUTIMA(TM) MODEL 2251 & MODEL 2600