Occluder, Internal Vessel, Temporary

FDA Pre-Market Approval

FDA Class 3 ·LEGOO ENDOVASCULAR OCCLUSION GEL

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·SELOX ST 53,SELOX ST 60,SELOX JT 45,SELOX JT 53,SETROX S 45,SETROX S53,SETROX S60,DEXTRUS 4135,DEXTRUS 4136,DETRUS 4137,

Sensor, Glucose, Invasive

FDA Pre-Market Approval

FDA Class 3 ·T SLIM G4 INSULIN PUMP WITH DEXCOM G4 PLATINUM CGM SYSTEM

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·RES-Q

Coronary Drug-Eluting Stent

FDA Pre-Market Approval

FDA Class 3 ·TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM (MONORAIL & OVER-THE-WIRE)

Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled

FDA Pre-Market Approval

FDA Class 3 ·ALLERGAN SILICONE-FILLED BREAST IMPLANTS

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·IMPLANTABLE PACEMAKER PULSE GENERATORS

Intravascular Radiation Delivery System

FDA Pre-Market Approval

FDA Class 3 ·GALILEO/GALILEO III INTRAVASCULAR RADIOTHERAPY SYSTEM

Device, Incontinence, Mechanical/Hydraulic

FDA Pre-Market Approval

FDA Class 3 ·AMS 800 Artificial Urinary Sphincter

Prosthesis, Ankle, Uncemented, Non-Constrained

FDA Pre-Market Approval

FDA Class 3 ·Scandinavian Total Ankle Replacement (STAR Ankle)

Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)

FDA Pre-Market Approval

FDA Class 3 ·ARCHITECT AUSAB / Alinity i Anti-HBs

Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)

FDA Pre-Market Approval

FDA Class 3 ·LIAISON XL MUREX HBeAg and LIAISON XL MUREX Control HBeAg

Catheter, Percutaneous (Valvuloplasty)

FDA Pre-Market Approval

FDA Class 3 ·INOUE BALLOON CATHETER

Implant, Intragastric For Morbid Obesity

FDA Pre-Market Approval

FDA Class 3 ·Obalon Balloon System with Navigation and Touch

Pump, Infusion, Implanted, Programmable

FDA Pre-Market Approval

FDA Class 3 ·Implantable System for Remodulin

Implant, Cochlear

FDA Pre-Market Approval

FDA Class 3 ·HiResolution Bionic Ear System

Scaffold, Infrapopliteal, Absorbable

FDA Pre-Market Approval

FDA Class 3 ·Esprit™ BTK Everolimus Eluting Resorbable Scaffold System

Prosthesis, Posterior Spinal Elements

FDA Pre-Market Approval

FDA Class 3 ·TOPS™ System

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·Akreos Posterior Chamber Intraocular Lens (IOL)

Agent, Absorbable Hemostatic, Collagen Based

FDA Pre-Market Approval

FDA Class 3 ·Avitene Microfibrillar Collagen Hemostat