KJ ZIRCONIA Implant System

FDA 510(k)

FDA Class 2 ·Dental

ARIX Ankle System

FDA 510(k)

FDA Class 2 ·Orthopedic

ARIX Wrist System

FDA 510(k)

FDA Class 2 ·Orthopedic

LnK Spinal Fixation System /OpenLoc-L Spinal Fixation System, AccelFix Spinal Fixation System.

FDA 510(k)

FDA Class 2 ·Orthopedic

RMF-2000

FDA 510(k)

FDA Class 2 ·Radiology

LeForte System II

FDA 510(k)

FDA Class 2 ·Dental

EXPD 114; EXPD 114G; EXPD 114P; EXPD 114PG

FDA 510(k)

FDA Class 2 ·Radiology

EXTRON 3; EXTRON 5; EXTRON 7

FDA 510(k)

FDA Class 2 ·Radiology

TDM Lumbar Interbody Fusion Cage System

FDA 510(k)

FDA Class 2 ·Orthopedic

Pre-Sintered Zirconia Coloring Liquid

FDA 510(k)

FDA Class 2 ·Dental

Dual Top Screw System

FDA 510(k)

FDA Class 2 ·Dental

PathLoc Lumbar Interbody Fusion Cage System

FDA 510(k)

FDA Class 2 ·Orthopedic

EXPD 4357; EXPD 4357P

FDA 510(k)

FDA Class 2 ·Radiology

EXSYS DEXi (EXSYS DEXi-D401S-FRM); EXSYS DEXi (EXSYS DEXi-A401S-FRM); EXSYS DEXi (EXSYS DEXi-D402S-FRM); EXSYS DEXi (EXSYS DEXi-A402S-FRM); EXSYS DEXi (EXSYS DEXi-D401P-FRM); EXSYS DEXi (EXSYS DEXi-A401P-FRM); EXSYS DEXi (EXSYS DEXi-D402P-FRM); EXSYS DEXi (EXSYS DEXi-A402P-FRM); EXSYS DEXi (EXSYS DEXi-D503T-FRM); EXSYS DEXi (EXSYS DEXi-A503T-FRM)

FDA 510(k)

FDA Class 2 ·Radiology

PathLoc-TA Expandable Lumbar Cage System

FDA 510(k)

FDA Class 2 ·Orthopedic

WHITESIDE BIOMECHANICS LOW PROFILE STAINLESS STEEL CABLE SYSTEM, MODEL BIO-1-1014

FDA 510(k)

FDA Class 2 ·Orthopedic

BIO-PROBE DISPOSABLE INSERT WITH; BALANCE BIOSURFACE, CARMEDA BIOACTIVE SURFACE, TRILLIUM BIOSURFACE

FDA 510(k)

FDA Class 2 ·Cardiovascular

BIO COMPRESSION COLD FLO, SINGLE CHAMBER INTERMITTENT AND MULTI-CHAMBER SEQUENTIAL MODELS

FDA 510(k)

FDA Class 2 ·Physical Medicine

gke Steri-Record Steam Mini-Bio-Plus self-contained biological indicator (SCBI)

FDA 510(k)

FDA Class 2 ·General Hospital

BIO QUANTUM TECHNOLOGIES, INC. HAND-HELD CO2 LASER SYSTEM MODEL HH-550S

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery