Automated Breast Ultrasound

FDA Pre-Market Approval

FDA Class 3 ·Invenia ABUS 2.0 Automated Breast Ultrasound System

Automated Insulin Dosing , Threshold Suspend

FDA Pre-Market Approval

FDA Class 3 ·ARTIFICIAL PANCREAS DEVICE SYSTEM, THRESHOLD SUSPEND

Automated Insulin Dosing , Threshold Suspend

FDA Pre-Market Approval

FDA Class 3 ·MiniMed Enlite Sensor

Aortic Valve, Prosthesis, Percutaneously Delivered

FDA Pre-Market Approval

FDA Class 3 ·Medtronic CoreValve Evolut PRO System

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

FDA Pre-Market Approval

FDA Class 3 ·PARADYM RF:MODELS VR 9250, DR 9550, CRT-D 9750; PARADYM MODELS VR 8250, DR 8550, CRT-D 8750

Stimulator, Hypoglossal Nerve, Implanted, Apnea

FDA Pre-Market Approval

FDA Class 3 ·Inspire Programmer System

Sensor, Glucose, Invasive, Non-Adjunctive, Factory-Calibrated, User-Initiated

FDA Pre-Market Approval

FDA Class 3 ·Freestyle Libre Flash Glucose Monitoring System

Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

FDA Pre-Market Approval

FDA Class 3 ·Saluda Medical Evoke SCS System

Sensor, Glucose, Invasive

FDA Pre-Market Approval

FDA Class 3 ·MiniMed Paradigm Real-Time Revel System

Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

FDA Pre-Market Approval

FDA Class 3 ·PRECISION SPECTRA SPINAL CORD STIMULATION(SCS) SYSTEM

System, Laser, Photodynamic Therapy

FDA Pre-Market Approval

FDA Class 3 ·PHOTOFRIN 630 PDT Laser

Device, Hemostasis, Vascular

FDA Pre-Market Approval

FDA Class 3 ·Vascade Vascular Closure System (VCS)

Material, Dressing, Surgical, Polylactic Acid

FDA Pre-Market Approval

FDA Class 3 ·HELICOTE ABSORBABLE COLLAGEN WOUND DRESSINGS FOR DENTAL SURGERY

Aid, Surgical, Viscoelastic

FDA Pre-Market Approval

FDA Class 3 ·NUVISC

Agent, Absorbable Hemostatic, Collagen Based

FDA Pre-Market Approval

FDA Class 3 ·CELLPAKER PLASMA COLLECTION DEVICE

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·PRIZM & VITALITY FAMILIES

Pump, Infusion, Implanted, Programmable

FDA Pre-Market Approval

FDA Class 3 ·SYNCHROMED INFUSION SYSTEM

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·LATITUDE COMMUNICATOR SOFTWARE & SYSTEM SOFTWARE

Stimulator, Autonomic Nerve, Implanted For Epilepsy

FDA Pre-Market Approval

FDA Class 3 ·VNS THERAPY SYSTEM

Automated Insulin Dosing , Threshold Suspend

FDA Pre-Market Approval

FDA Class 3 ·MINIMED 530G SYSTEM AND MINILINK REAL-TIME SYSTEM