BLOOD FLOW ANALYZER (BFA), MODEL 408-100-01

FDA 510(k)

FDA Class 2 ·Ophthalmic

LDR SPINE SPINETUNE TL SPINAL SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

T2 GREATER TROCHANTER NAIL

FDA 510(k)

FDA Class 2 ·Orthopedic

ROCKWOOD CLAVICLE PINS

FDA 510(k)

FDA Class 2 ·Orthopedic

UNIVERSAL CEMENTED CUP

FDA 510(k)

FDA Class 2 ·Orthopedic

EVOLUTION Revision Tibial Base, EVOLUTION Revision Tibial Block Augment, EVOLUTION Revision Modular Keels, EVOLUTION Revision Stem Adapters (offset and extension), EVOLUTION Revision Cemented Stem Extensions, Canal Filling Stem Extensions

FDA 510(k)

FDA Class 2 ·Orthopedic

NEO Pedicle Screw System™

FDA 510(k)

FDA Class 2 ·Orthopedic

SeaSpine Spinous Process System

FDA 510(k)

FDA Class 2 ·Orthopedic

MotoBAND CP Implant System

FDA 510(k)

FDA Class 2 ·Orthopedic

Exactech® Truliant™ Line Extensions

FDA 510(k)

FDA Class 2 ·Orthopedic

LENSAR Laser System – fs 3D (LLS-fs 3D)

FDA 510(k)

FDA Class 2 ·Ophthalmic

MODIFICATION TO RTA RETINAL THICKNESS ANALYZER

FDA 510(k)

FDA Class 2 ·Ophthalmic

PYXIS 3D Titanium Cage System

FDA 510(k)

FDA Class 2 ·Orthopedic

AMERI. MEDICAL OPTICS ARGON LASER PHOTO

FDA 510(k)

FDA Class 2 ·Ophthalmic

DURASOFT 2 (PHEMFILCON A) OPTIFIT TORIC (HYDROPHILIC) CONTACT LENSES, DURASOFT 2 (PHEMFILCON A) SHERICAL ( HYDROPHILIC)C

FDA 510(k)

FDA Class 2 ·Ophthalmic

DC-3300 LASER DIODE PHOTOCOAGULATOR

FDA 510(k)

FDA Class 2 ·Ophthalmic

OTE MPS 045 Multi-purpose Lens Care Solution

FDA 510(k)

FDA Class 2 ·Ophthalmic

OMNIFIT (TM) TOTAL KNEE PROSTHESIS SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

MotoBand¿ CP Implant System

FDA 510(k)

FDA Class 2 ·Orthopedic

COMPLETE BLINK-N-CLEAN LENS DROPS

FDA 510(k)

FDA Class 2 ·Ophthalmic