Sensor, Glucose, Invasive

FDA Pre-Market Approval

FDA Class 3 ·DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM

Stimulator, Electrical, Implanted, For Parkinsonian Tremor

FDA Pre-Market Approval

FDA Class 3 ·Activa Deep Brain Stimulation Therapy System

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·Attain Bipolar OTW Lead, Attain OTW LV Lead

Agent, Absorbable Hemostatic, Non-Collagen Based

FDA Pre-Market Approval

FDA Class 3 ·SURGICEL® SNOW™ Absorbable Hemostat

Stimulator, Electrical, Implanted, For Parkinsonian Tremor

FDA Pre-Market Approval

FDA Class 3 ·ACTIVA THERAPY FOR DBS

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·CARELINK MONITORS 2490H, AND MODEL 2020A CARDIOSIGHT READER

Applicator, Hyperthermia, Superficial, Rf/Microwave

FDA Pre-Market Approval

FDA Class 3 ·HYPERTHERMIA SYSTEM 100 A

Stimulator, Electrical, Implanted, For Parkinsonian Tremor

FDA Pre-Market Approval

FDA Class 3 ·ACTIVARC AND ACTIVAPC

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·Revo MRI, EnRhythm MRI

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·CAPSURE LEADS 5038, 5038L, 5038S,IMW14Q,IMW15Q, IMW16Q, IMW17Q, IMW18Q, PRODIGY IPG, 8158

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

FDA Pre-Market Approval

FDA Class 3 ·PROLIEVE THERMODILATATION SYSTEM CATHETER AND HEAT EXCHANGER

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·EVIA/ENTOVIS & VARIOUS MODELS OF PHILOS/PHILOS2 & CYLOS PULSE GENERATORS; SELOX JT/ST/SR, DEXTRUS, SELTROX S, SLX

Pump, Infusion, Implanted, Programmable

FDA Pre-Market Approval

FDA Class 3 ·SYNCHROMED II PROGRAMMABLE DRUG PUMP

Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Metal/Polymer, Mobile Bearing

FDA Pre-Market Approval

FDA Class 3 ·LCS TOTAL KNEE SYSTEM

Prosthesis, Metatarsophalangeal Joint Cartilage Replacement Implant

FDA Pre-Market Approval

FDA Class 3 ·CARTIVA SYNTHETIC CARTILAGE IMPLANT

Agent, Absorbable Hemostatic, Non-Collagen Based

FDA Pre-Market Approval

FDA Class 3 ·SURGICAL ABSORBABLE HEMOSTAT

Heart-Valve, Non-Allograft Tissue

FDA Pre-Market Approval

FDA Class 3 ·FREESTYLE AORTIC ROOT BIOPROSTHESIS, MODELS 995, 995MS AND 995CS

Defibrillator, Implantable, Dual-Chamber

FDA Pre-Market Approval

FDA Class 3 ·TUPOS LV/ATX & KRONOS LV-T CRT-D & COROX OWT STEROID LV PACING LEAD

Replacement Heart-Valve

FDA Pre-Market Approval

FDA Class 3 ·HANCOCK LOW POROSITY VALVED CONDUIT

Stimulator, Electrical, Implanted, For Parkinsonian Tremor

FDA Pre-Market Approval

FDA Class 3 ·SOLETRA, KINETRA, ACTIVA SC, POCKET ADAPTOR