Scaffold, Infrapopliteal, Absorbable

FDA Pre-Market Approval

FDA Class 3 ·ESPRIT™ BTK Everolimus Eluting Bioresorbable Scaffold System

Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

FDA Pre-Market Approval

FDA Class 3 ·INJEX MODEL 97791 BUMPY & MODEL 97792 BI-WING ANCHOR KITS

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval

FDA Class 3 ·Natural Eyes HydraWear™ XW Multifocal

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval

FDA Class 3 ·COOPERVISION, INC. HYDRASOFT, HYDRASOFT TORIC, HYDRASOFT XW AND HYDRASOFT TORIC XW (METHAFILCON B) SOFT (HYDROPHILIC)...

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval

FDA Class 3 ·HYDRASOFT, HYDRASOFT TORIC, HYDRASOFT XW AND HYDRASOFT TORIC XW (METHALICON B) SOFT (HYDROPHILIC) CONTACT LENSES

LIFEPAK 600 AUTOMATED EXTERNAL DEFIBRILLATOR

FDA 510(k)

FDA Class 3 ·Cardiovascular

Stent, Coronary

FDA Pre-Market Approval

FDA Class 3 ·BX VELOCITY STENT ON RAPTORRAIL STENT DELIVERY SYSTEM(RX)/BX VELOCITY STENT WITHHEPACOAT ON RAPTORRAIL STENT DELIVERY

Stent, Coronary

FDA Pre-Market Approval

FDA Class 3 ·BX VELOCITY STENT WITH RAPTOR OVER-THE-WIRE DELIVERY SYSTEM, BX VELOCITY STENT ON RAPTORRAIL TX DELIVERY SYSTEM

Stent, Coronary

FDA Pre-Market Approval

FDA Class 3 ·BX VELOCITY STENT ON RAPTORRAIL STENT DELIVERY SYSTEM AND BX VELOCITY STENT WITH HEPACOAT ON RAPTORRAIL STENT DELIVERY

Stent, Coronary

FDA Pre-Market Approval

FDA Class 3 ·BX VELOCITY/HEPACOAT ON RAPTOR STENT SYSTEM

Stent, Coronary

FDA Pre-Market Approval

FDA Class 3 ·BX VELOCITY(TM) WITH HEPACOAT(TM) ON RAPTOR (TM) STENT SYSTEM FOR CORONARY ARTERIES

Stent, Coronary

FDA Pre-Market Approval

FDA Class 3 ·BX VELOCITY BALLOON EXPANDABLE STENT WITH RAPTOR OTW DELIVERY SYSTEM AND BX VELOCITY STENT WITH HEPACOAT ON RAPTOR OTW

Stent, Coronary

FDA Pre-Market Approval

FDA Class 3 ·BX VELOCITY BALLOON-EXPANDABLE STENT WITH RAPTOR OVER THE WIRE DELIVERY SYSTEM/BX VELOCITY WITH HEPACOAT ON RAPTOR STENT

Stent, Coronary

FDA Pre-Market Approval

FDA Class 3 ·BX SONIC BALLOON EXPANDABLE STENT OTW DELIVERY SYSTEM

Stent, Coronary

FDA Pre-Market Approval

FDA Class 3 ·BX VELOCITY STENT ON RAPTORRAIL STENT DELIVERY SYSTEM

Stent, Coronary

FDA Pre-Market Approval

FDA Class 3 ·BX SONIC BALLOON EXPANDABLE STENT OTW DELIVERY SYSTEM

Stent, Coronary

FDA Pre-Market Approval

FDA Class 3 ·BX VELOCITY WITH HEPACOAT ON RAPTOR STENT SYSTEM

Stent, Coronary

FDA Pre-Market Approval

FDA Class 3 ·HEPACOAT ON BX SONIC BALLOON-EXPANDABLE STENT OTW DELIVERY SYSTEM

Stent, Coronary

FDA Pre-Market Approval

FDA Class 3 ·BX VELOCITY STENT ON RAPTOR RAIL STENT DELIVERY SYSTEM (RX)

Stent, Coronary

FDA Pre-Market Approval

FDA Class 3 ·HEPACOAT ON BX SONIC BALLOON-EXPANDABLE TENT OTW DELIVERY SYSTEM