Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·MODEL P11 MODIFIED J LOOP POSTERIOR CHAMBER IOL

Stent, Carotid

FDA Pre-Market Approval

FDA Class 3 ·CORDIS PRECISE NITINOL STENT SYSTEMS

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval

FDA Class 3 ·VISTAKON (SENOFILCON A) CONTACT LENS, CLEAR AND VISIBILITY TINTED WITH UV BLOCKER

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval

FDA Class 3 ·Senofilcon A Reactive Monomer Mix (RMM) Batches

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·MODEL P13 MODEIFIED C LOOP POSTERIOR CHAMBER

Test, Urea Adult And Pediatric (Breath),

FDA Pre-Market Approval

FDA Class 3 ·PyloPlus® UBT System

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval

FDA Class 3 ·VISTAKON (etafilcon A) Brand Contact Lenses

Device, Hemostasis, Vascular

FDA Pre-Market Approval

FDA Class 3 ·EXOSEAL® Vascular Closure Device

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval

FDA Class 3 ·ACUVUE(R) (ETAFILCON A) EXTENDED WEAR CONTACT LENS (CLEAR AND TINTED WITH UV BLOCKER)

Stent, Coronary

FDA Pre-Market Approval

FDA Class 3 ·CROSSFLEX LC BALLOON EXPANDABLE STENT (ANGLED END/SQUARE END) WITH OVER THE WIRE DELIVERY SYSTEM

Stent, Coronary

FDA Pre-Market Approval

FDA Class 3 ·BX VELOCITY STENT WITH HEPACOAT ON RAPTORRAIL STENT DELIVERY SYSTEM (RX)

Tissue Adhesive For Use In Embolization Of Brain Arteriovenous Malformations

FDA Pre-Market Approval

FDA Class 3 ·TRUFILL N-BUTYL CYANOACRYLATE (N-BCA) LIQUID EMBOLIC SYSTEM

System, Esophageal Pacing

FDA Pre-Market Approval

FDA Class 3 ·STAT-PACE II

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·MAESTRO SERIES 500 P.G. MODELS 501, 505, 509

Device, Hemostasis, Vascular

FDA Pre-Market Approval

FDA Class 3 ·MYNX ACE VASCULAR CLOSURE DEVICE

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·ENDOTOXIN TEST METHOD

Stent, Superficial Femoral Artery

FDA Pre-Market Approval

FDA Class 3 ·SMA RT CONTROL AND SMART VASCULAR STENT SYSTEMS

Test, Urea Adult And Pediatric (Breath),

FDA Pre-Market Approval

FDA Class 3 ·PyloPlus Urea Breath Test Pro Analyzer, PyloPlus Urea Breath Test Lab Analyzer

Stent, Coronary

FDA Pre-Market Approval

FDA Class 3 ·Tryton Side Branch Stent

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval

FDA Class 3 ·SOFT-FORM 55EW; LL-55; SOFTCON EW2