Agent, Bulking, Injectable For Gastro-Urology Use

FDA Pre-Market Approval

FDA Class 3 ·COAPTITE Injectable Implant

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval

FDA Class 3 ·Comfilcon A Soft (Hydrophilic) Extended Wear Contact Lenses

Sealant, Polymerizing

FDA Pre-Market Approval

FDA Class 3 ·Coseal Surgical Sealant

Device, Hemostasis, Vascular

FDA Pre-Market Approval

FDA Class 3 ·Cordis Exoseal Vascular Closure Device

Implant, Dermal, For Aesthetic Use

FDA Pre-Market Approval

FDA Class 3 ·RADIESSE (+) Lidocaine Dermal Filler

Stent, Superficial Femoral Artery

FDA Pre-Market Approval

FDA Class 3 ·INNOVA VASCULAR SELF-EXPANDING STENT WITH DELIVERY SYSTEM

Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval

FDA Class 3 ·RF MARINR CATHETERS, RF ENHANCER II CATHETERS, RF CONTRACTR CATHETERS AND RF CONDUCTR CATHETERS

Implant, Dermal, For Aesthetic Use

FDA Pre-Market Approval

FDA Class 3 ·RADIESSE Injectable Implant

Cancer-Related Germline Gene Mutation Detection System

FDA Pre-Market Approval

FDA Class 3 ·BRACAnalysis CDx

Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Ceramic/Metal, Cemented Or Uncemented

FDA Pre-Market Approval

FDA Class 3 ·DEPUY CERAMAX CERAMIC TOTAL HIP SYSTEM

Lipoprotein, Low Density, Removal

FDA Pre-Market Approval

FDA Class 3 ·LIPOSORBER LA-15 SYSTEM

Ventricular (Assist) Bypass

FDA Pre-Market Approval

FDA Class 3 ·HeartMate II LVAS

Barrier, Absorbable, Adhesion

FDA Pre-Market Approval

FDA Class 3 ·INTERCEED ABSORBABLE ADHESION BARRIER

Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Ceramic/Metal, Cemented Or Uncemented

FDA Pre-Market Approval

FDA Class 3 ·R3™ Delta Ceramic Acetabular System

Implant, Dermal, For Aesthetic Use

FDA Pre-Market Approval

FDA Class 3 ·Bellafill Dermal Filler

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·EMBLEM MRI S-CD/ EMBLEM S-CD Pulse Generator (PG)

Stent, Iliac

FDA Pre-Market Approval

FDA Class 3 ·S.M.A.R.T NITINOL STENT SYSTEM & CONTROL NITINOL STENT SYSTEM

Ventricular (Assist) Bypass

FDA Pre-Market Approval

FDA Class 3 ·HeartMate 3™ Left Ventricular Assist System

Prosthesis, Intervertebral Disc

FDA Pre-Market Approval

FDA Class 3 ·prodisc® C

Prosthesis, Intervertebral Disc

FDA Pre-Market Approval

FDA Class 3 ·prodisc® L