Permanent Defibrillator Electrodes

FDA Pre-Market Approval

FDA Class 3 ·SWEET TIP RX, SWEET PICOTIP RX, FLEXTEND FAMILIES OF PACING LEADS

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval

FDA Class 3 ·Biofinity (comfilcon A) Soft (Hydrophilic) Contact Lenses for Extended Wear

Cytomegalovirus (Cmv) Dna Quantitative Assay

FDA Pre-Market Approval

FDA Class 2 ·COBAS AMPLIPREP/COBAS TAQMAN CMV TEST

Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

FDA Pre-Market Approval

FDA Class 3 ·SPINAL CORD STIMULATION

Implant, Dermal, For Aesthetic Use

FDA Pre-Market Approval

FDA Class 3 ·ZYPLAST COLLAGEN IMPLANT ZYDERM I AND II COLLAGEN IMPLANT

System, Endovascular Graft, Aortic Aneurysm Treatment

FDA Pre-Market Approval

FDA Class 3 ·ZENITH TX2 TAA ENDOVASCULAR GRAFT

Implant, Dermal, For Aesthetic Use

FDA Pre-Market Approval

FDA Class 3 ·RADIESSE Injectable Implant, RADIESSE Hands, and RADIESSE (+) Lidocaine Dermal Filler

Implant, Dermal, For Aesthetic Use

FDA Pre-Market Approval

FDA Class 3 ·BELOTERO BALANCE Dermal Filler, BELOTERO BALANCE (+) Lidocaine Dermal Filler

Pump, Infusion, Implanted, Programmable

FDA Pre-Market Approval

FDA Class 3 ·SynchroMed® Infusion System, Ascenda® Intrathecal Catheters

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·DELTA, VISTA FAMILIES, PACEMAKER

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval

FDA Class 3 ·AFP CARDIAC PACING SYSTEM, SENSOLOG CARDIAC PACING SYSTEM, AND SYNCHRONY CARDIAC PACING SYSTEM

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·ADVANTIO; INGENIO; VITALIO; FORMIO; ESSENTIO; PROPONENT; ACCOLADE; ALTRUA 2 PACEMAKERS.

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·CORONARY FLEXTOME CUTTING BALLOON DEVICE

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·C-flex 570C, C-flex Aspheric 970C and 600C Aspheric Intraocular lenses

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

FDA Pre-Market Approval

FDA Class 3 ·Transcend® Hip Articulation System

Agent, Absorbable Hemostatic, Non-Collagen Based

FDA Pre-Market Approval

FDA Class 3 ·Arista AH Absorbable Hemostat

Bone Cement

FDA Pre-Market Approval

FDA Class 2 ·SURGICAL SIMPLEX(R) P RADIOPAQUE BONE CEMENT

Drug Eluting Permanent Left Ventricular (Lv) Pacemaker Electrode

FDA Pre-Market Approval

FDA Class 3 ·CONSULTA CRT-P, SYNCRA CRT-P

Heart-Valve, Non-Allograft Tissue

FDA Pre-Market Approval

FDA Class 3 ·FREESTYLE AORTIC ROOT BIOPROSTHESIS

Coronary Drug-Eluting Stent

FDA Pre-Market Approval

FDA Class 3 ·SYNERGY Everolimus-Eluting Platinum Chromium Coronary Stent System and SYNERGY XD Everolimus-Eluting Platinum Chromium C