Lenses, Soft Contact, Daily Wear

FDA Pre-Market Approval

FDA Class 2 ·GELFLEX(R) (DIMEFILCON A) CONTACT LENS

Lenses, Soft Contact, Daily Wear

FDA Pre-Market Approval

FDA Class 2 ·GELFLEX(R) (DIMEFILCON A) CONTACT LENS

Lenses, Soft Contact, Daily Wear

FDA Pre-Market Approval

FDA Class 2 ·GELFLEX(R) (DIMEFILCON A) CONTACT LENS

Pulse-Generator, Pacemaker, External

FDA Pre-Market Approval

FDA Class 2 ·MODEL4553 MICRO-PACE,DUAL-CHAMBER,DDD TEMPORARY CARDIAC PACEMAKER

Generator, Pulse, Pacemaker, External Programmable (For Electrophysiological Studies Only)

FDA Pre-Market Approval

FDA Class 2 ·MICRO-PACE MODEL 4553 DUAL CHAMBER DDD TEMPORARY CARDIAC PACEMAKER

Pulse-Generator, Pacemaker, External

FDA Pre-Market Approval

FDA Class 2 ·MICRO-PACE MODEL 4580 DUAL-CHAMBER,DDD,TEMPORARY CARDIAC PACEMAKER

K2M Growing Spine System

FDA 510(k)

FDA Class 2 ·Orthopedic

Polaris Spinal Growth System

FDA 510(k)

FDA Class 2 ·Orthopedic

CrossOver Cross Connectors, DePuy PULSE Thoracolumbar Screw System, EXPEDIUM Fenestrated Screw System, EXPEDIUM SFX Cross Connectors, EXPEDIUM Spine System, EXPEDIUM VERSE Spine System, E-Z Link Cross Connectors, ISOLA Spine System, MONARCH Spine System, MOSS MIAMI Spine System, TiMX Low Back System, VIPER Fenestrated Screw System, VIPER PRIME System, VIPER PRIME Fenestrated Screws, VIPER SAI (Sacral-Alar-Iliac), VIPER System, VIPER 2 System, VSP Spine System

FDA 510(k)

FDA Class 2 ·Orthopedic

SHILLA GROWTH GUIDANCE SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

VerteGlide Spinal Growth Guidance System

FDA 510(k)

FDA Class 2 ·Orthopedic

NuVasive® Growth Rod Conversion Set

FDA 510(k)

FDA Class 2 ·Orthopedic

CREO® Stabilization System, REVERE® Stabilization System

FDA 510(k)

FDA Class 2 ·Orthopedic

Xia® Growth Rod Conversion Set

FDA 510(k)

FDA Class 2 ·Orthopedic

MARVEL™ Growing Rods

FDA 510(k)

FDA Class 2 ·Orthopedic

ISOLA AND EXPEDIUM GROWING SPINE SYSTEMS

FDA 510(k)

FDA Class 2 ·Orthopedic

Daytona® Small Stature Growth Rod Conversion Set

FDA 510(k)

FDA Class 2 ·Orthopedic

CD HORIZON SPINAL SYSTEM GROWTH ROD SET

FDA 510(k)

FDA Class 2 ·Orthopedic

CD HORIZON Growth Rod Conversion Set

FDA 510(k)

FDA Class 2 ·Orthopedic

MILLENNIUM

FDA 510(k)

FDA Class 2 ·Dental