COEUR, INC. FRONTLOAD FOR OPTIVANTAGE POWER INJECTOR

FDA 510(k)

FDA Class 2 ·Cardiovascular

WMT MODULAR ULNAR HEAD IMPLANT

FDA 510(k)

FDA Class 2 ·Orthopedic

DeRoyal Laprador Specimen Retrieval System

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

SOMAVAC 100 Sustained Vacuum System

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

TOP SUN MODELS 100,101,103 &139, 139-1, 139-3

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

REVOLUTION SPINAL FIXATION SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

R3 XLPE LINERS

FDA 510(k)

FDA Class 2 ·Orthopedic

SPINEDESIGN Spine Surgery Planning (Software Application)

FDA 510(k)

FDA Class 2 ·Radiology

MUELLER HINTON AGAR

FDA 510(k)

FDA Class 2 ·Microbiology

VENTILATION TUBES WITH HYDROGEL COATING

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

CORTICAL BONE SCREW (EUROPEAN STYLE)

FDA 510(k)

FDA Class 2 ·Orthopedic

PC-BEADS POSTCOITAL TEST

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

Subtalar Spacer System (STS)

FDA 510(k)

FDA Class 2 ·Orthopedic

ECAT SCANNER (MODEL 921)

FDA 510(k)

FDA Class 2 ·Radiology

Fort Defiance Industries FRONT-LINE Field Sterilizer FL120, Fort Defiance Industries FRONT-LINE Field Sterilizer FL135

FDA 510(k)

FDA Class 2 ·General Hospital

HANSEN-STREET TYPE INTRAMEDULLARY NAIL

FDA 510(k)

FDA Class 2 ·Orthopedic

REFLECTION MODIFIED ACETABULAR SHELLS

FDA 510(k)

FDA Class 2 ·Orthopedic

Wright Jones Fracture System

FDA 510(k)

FDA Class 2 ·Orthopedic

PROFEMUR® GLADIATOR® Cemented Classic Stem

FDA 510(k)

FDA Class 2 ·Orthopedic

PTFE PISTON

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat