Implant, Cochlear

FDA Pre-Market Approval

FDA Class 3 ·NUCLEUS 24 COCHLEAR IMPLANT SYSTEM FOR ADULTS AND CHILDREN WITH CI 11=11=2M DOUBLE ARRAY COCHLEAR IMPLANT

Automated Insulin Dosing , Threshold Suspend

FDA Pre-Market Approval

FDA Class 3 ·ENLITE SENSOR

Agent, Absorbable Hemostatic, Collagen Based

FDA Pre-Market Approval

FDA Class 3 ·HELISTAT HELITENE ABSORBABLE COLLAGEN HEMOSTATIC AGENT

Automated Breast Ultrasound

FDA Pre-Market Approval

FDA Class 3 ·Invenia ABUS Premium, Invenia ABUS Prime

Pump, Infusion, Implanted, Programmable

FDA Pre-Market Approval

FDA Class 3 ·ARROW INTERNATIONAL MODEL 3000/3000-16/3000-50 IMPLANTABLE

Sensor, Glucose, Invasive

FDA Pre-Market Approval

FDA Class 3 ·Sensor-Enabled Pump System-Continuous Glucose Monitoring System

System, Hyperthermia, Rf/Microwave (Benign Prostatic Hyperplasia),Thermotherapy

FDA Pre-Market Approval

FDA Class 3 ·UROLOGIX TARGIS SYSTEM

Sealant, Microbial

FDA classification

FDA Class 2 ·Sealant, Microbial

Cabinet X-Ray, Vehicle And Cargo

FDA classification

FDA Not Classified ·Cabinet X-Ray, Vehicle And Cargo

Atrial Fibrillation Risk Prediction Machine Learning-Based Notification Software

FDA classification

FDA Class 2 ·Atrial Fibrillation Risk Prediction Machine Learning-Based Notification Software

Suprapubic Catheter Accessories

FDA classification

FDA Class 1 ·Suprapubic Catheter Accessories

Laser Aiming Product, Visible

FDA classification

FDA Not Classified ·Laser Aiming Product, Visible

Ventilatory Electrical Impedance Tomograph

FDA classification

FDA Class 2 ·Ventilatory Electrical Impedance Tomograph

Ankle Fusion Cage

FDA classification

FDA Class 2 ·Ankle Fusion Cage

Projector

FDA classification

FDA Not Classified ·Projector

Syringe, Piston, Reprocessed

FDA classification

FDA Class 2 ·Syringe, Piston, Reprocessed

Collector, Urine, Powered, Non Indwelling Catheter

FDA classification

FDA Class 1 ·Collector, Urine, Powered, Non Indwelling Catheter

Breast Pump Accessory, Milk Expression Aid, Via Positive Pressure

FDA classification

FDA Class 1 ·Breast Pump Accessory, Milk Expression Aid, Via Positive Pressure

Laser Target Designator

FDA classification

FDA Not Classified ·Laser Target Designator

Transcatheter Septal Occluder

FDA Pre-Market Approval

FDA Class 3 ·AMPLATZER PFO OCCLUDER