Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·ADAPTA,VERSA ,SENSIA IPG, ADVISA DR IPG.ADVISA DR MRI IPG,ENPULSE E1 IPG,ENPULSE E2 IPG, ENRHYTHM IPG,KAPPA D(KAPPA 700)

Tricuspid Valve Repair Device, Percutaneously Delivered

FDA classification

FDA Class 3 ·Tricuspid Valve Repair Device, Percutaneously Delivered

Automated External Defibrillators (Non-Wearable)

FDA classification

FDA Class 3 ·Automated External Defibrillators (Non-Wearable)

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

FDA classification

FDA Class 3 ·Next Generation Sequencing Oncology Panel, Somatic Or Germline Variant Detection System

Over-The-Counter Automated External Defibrillator

FDA classification

FDA Class 3 ·Over-The-Counter Automated External Defibrillator

Intervertebral Fusion Device With Bone Graft, Solid-Sphere, Lumbar

FDA classification

FDA Class 3 ·Intervertebral Fusion Device With Bone Graft, Solid-Sphere, Lumbar

Permanent Defibrillator Electrodes

FDA classification

FDA Class 3 ·Permanent Defibrillator Electrodes

Optoacoustic Imaging System

FDA classification

FDA Class 3 ·Optoacoustic Imaging System

Leadless Cardiac Resynchronization Therapy (Crt)

FDA classification

FDA Class 3 ·Leadless Cardiac Resynchronization Therapy (Crt)

Diaphragmatic/Phrenic Nerve Laparoscopically-Implanted Stimulator

FDA classification

FDA Class 3 ·Diaphragmatic/Phrenic Nerve Laparoscopically-Implanted Stimulator

Digital Breast Tomosynthesis

FDA classification

FDA Class 3 ·Digital Breast Tomosynthesis

Intraocular, Pressure Measuring Device

FDA classification

FDA Class 3 ·Intraocular, Pressure Measuring Device

Organ Care System (Ocs) Heart System

FDA classification

FDA Class 3 ·Organ Care System (Ocs) Heart System

Fluorescence Imaging For Breast Cancer Detection

FDA classification

FDA Class 3 ·Fluorescence Imaging For Breast Cancer Detection

Stent, Urethral, Prostatic, Semi-Permanent

FDA classification

FDA Class 3 ·Stent, Urethral, Prostatic, Semi-Permanent

Light Source System, Diagnostic Endoscopic

FDA classification

FDA Class 3 ·Light Source System, Diagnostic Endoscopic

Absorbable Collagen Hemostatic Agent With Thrombin

FDA classification

FDA Class 3 ·Absorbable Collagen Hemostatic Agent With Thrombin

Combination Compression/Decompression Manual Chest Pump With Impedance Respiratory Valve

FDA classification

FDA Class 3 ·Combination Compression/Decompression Manual Chest Pump With Impedance Respiratory Valve

Rt-Pcr Multigene Expression Test, Sentinel Lymph Node, Cancer Metastasis Detection

FDA classification

FDA Class 3 ·Rt-Pcr Multigene Expression Test, Sentinel Lymph Node, Cancer Metastasis Detection

Intrasaccular Flow Disruption Device

FDA classification

FDA Class 3 ·Intrasaccular Flow Disruption Device