Sensor, Glucose, Invasive

FDA Pre-Market Approval

FDA Class 3 ·G4 PLATINUM CONTIUOUS GLUCOSE MONITORING SYSTEM

Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval

FDA Class 3 ·Nitron CryoConsole and Nitron Remote

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·CT LUCIA 621P

Automated Insulin Dosing , Threshold Suspend

FDA Pre-Market Approval

FDA Class 3 ·ENLITE SENSOR

Implant, Cochlear

FDA Pre-Market Approval

FDA Class 3 ·AURIA HARMONY HIRESOLUTION BIONIC EAR SYSTEM

Automated Insulin Dosing , Threshold Suspend

FDA Pre-Market Approval

FDA Class 3 ·MiniMed 530G System

Automated Insulin Dosing , Threshold Suspend

FDA Pre-Market Approval

FDA Class 3 ·MiniMed 630G System

Sensor, Glucose, Invasive

FDA Pre-Market Approval

FDA Class 3 ·Real-Time REVEL System

Sensor, Glucose, Invasive

FDA Pre-Market Approval

FDA Class 3 ·iPro2 System

Automated Insulin Dosing Device System, Single Hormonal Control

FDA Pre-Market Approval

FDA Class 3 ·MiniMed 670G System

Sensor, Glucose, Invasive

FDA Pre-Market Approval

FDA Class 3 ·Guardian Connect System

Kit, Dna Detection, Human Papillomavirus

FDA Pre-Market Approval

FDA Class 3 ·COBAS HPV TEST, 240 TESTS; COBAS HPV TEST 960 TESTS

Automated Insulin Dosing , Threshold Suspend

FDA Pre-Market Approval

FDA Class 3 ·MiniMed 630G System with SmartGuard

Gastric Emptying Breath Test

FDA Pre-Market Approval

FDA Class 3 ·13 C-Spirulina Gastric Emptying Breath Test (GEBT)

Automated Insulin Dosing Device System, Single Hormonal Control

FDA Pre-Market Approval

FDA Class 3 ·Guardian Link (3) Transmitter

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·PLEXA S 60, PLEXA SD 60/16, PLEXA PROMRI S 65, PLEXA PROMRI S 75, PLEXA PROMRI SD 65/16, PLEXA PROMRI SD 65/18, PLEXA PR

Sensor, Glucose, Invasive

FDA Pre-Market Approval

FDA Class 3 ·DEXCOM G4TM PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM

Automated Insulin Dosing , Threshold Suspend

FDA Pre-Market Approval

FDA Class 3 ·ENLITE SENSOR

Sensor, Glucose, Invasive

FDA Pre-Market Approval

FDA Class 3 ·ANIMAS VIBE SYSTEM

Sensor, Glucose, Implanted, Non-Adjunctive Use

FDA Pre-Market Approval

FDA Class 3 ·Eversense Continuous Glucose Monitoring System