Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval

FDA Class 3 ·NIGHT & DAY 30 NIGHT EXTENDED WEAR SOFT CONTACT LENS

Assay,Enzyme Linked Immunosorbent,Parvovirus B19 Igm

FDA Pre-Market Approval

FDA Class 3 ·BIOTRIN INTERNATIONAL'S PARVOVIRUS B19 IGM IN VITRO DIAGNOSTIC DEVICE

Assay,Enzyme Linked Immunosorbent,Parvovirus B19 Igg

FDA Pre-Market Approval

FDA Class 3 ·BIOTRIN INTERNATIONALS PARVOVIRUS B19 IGG IN VITRO DIAGNOSTIC DEVICE

Embolization Agent, Vascular

FDA Pre-Market Approval

FDA Class 3 ·Lava Liquid Embolic System (Lava LES)

Processor, Cervical Cytology Slide, Automated

FDA Pre-Market Approval

FDA Class 3 ·PREPSTAIN SYSTEM

Heart-Valve, Mechanical

FDA Pre-Market Approval

FDA Class 3 ·ST. JUDE MEDICAL MECHANICAL HEART VALVE SJM MASTERS SERIES WITH SILZONE

Enzyme Immunoassay, Fetal Fibronectin

FDA Pre-Market Approval

FDA Class 3 ·ADEZA FETAL FIBRONECTIN EIK

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·BIOTRONIK GEMNOS 04, 04A, AND TC 04

Permanent Pacemaker Electrode

FDA Pre-Market Approval

FDA Class 3 ·CAPSURE Z/SP

Permanent Pacemaker Electrode

FDA Pre-Market Approval

FDA Class 3 ·SUREFIX

System, Endovascular Graft, Aortic Aneurysm Treatment

FDA Pre-Market Approval

FDA Class 3 ·ANEURX STENT GRAFT SYSTEM

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval

FDA Class 3 ·FOCUS NIGHT & DAY (LOTRAFILCON A) EXTENDED WEAR SOFT CONTACT LENSES

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval

FDA Class 3 ·AIR OPTIX NIGHT & DAY AQUA (LOTRAFILCON A) SOFT CONTACT LENSES

Daily Wear Soft Contact Lens To Reduce The Progression Of Myopia

FDA Pre-Market Approval

FDA Class 3 ·MiSight 1 Day (omafilcon A) Soft (Hydrophilic) Daily Wear Contact Lenses

Acid, Hyaluronic, Intraarticular

FDA Pre-Market Approval

FDA Class 3 ·ORTHOVISC HIGH MOLECULAR WEIGHT HYALURONAN

Inhibitor, Peridural Fibrosis (Adhesion Barrier)

FDA Pre-Market Approval

FDA Class 3 ·ADCON-L ADHESION CONTROL IN A BARRIER GEL

Device, Angioplasty, Laser, Coronary

FDA Pre-Market Approval

FDA Class 3 ·ETHYLENE OXIDE (EO)STERILIZATION EQUIPMENT

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·3M VISION CARE POSTERIOR CHAMBER IOL,PERSPEX CQ-UV

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·LASER WELDING REVERSE HAPTIC ASPECT RATIO

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·ZIRCONIA SILICATE BEAD IOL TUMBLE POLISHING