DEPUY SIGMA TIBIAL INSERTS

FDA 510(k)

FDA Class 2 ·Orthopedic

DEPUY SIGMA XLK TIBIAL INSERTS

FDA 510(k)

FDA Class 2 ·Orthopedic

ZIRCONIA ARTICUL/EZE FEMORAL BALLS

FDA 510(k)

FDA Class 2 ·Orthopedic

DEPUY ORTHOTECH RESTORE ORTHOBIOLOGIC SOFT TISSUE IMPLANT

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

PALJET-B

FDA 510(k)

FDA Class 2 ·Cardiovascular

10.5MM REPLICA HIP STEM

FDA 510(k)

FDA Class 2 ·Orthopedic

ANATOMIC MODULAR KNEE (AMK) POSTERIOR STABILIZED

FDA 510(k)

FDA Class 2 ·Orthopedic

ARTICUL/EZE FEMORAL HEADS

FDA 510(k)

FDA Class 2 ·Orthopedic

TEMPFIX EXTERNAL FIXATION SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

Susceptibility Test Cards, Antimicrobial

FDA Pre-Market Approval

FDA Class 2 ·VITEK 2 GRAM POSITIVE AST FOR HIGH-LEVEL STREPTOMYCIN

Susceptibility Test Cards, Antimicrobial

FDA Pre-Market Approval

FDA Class 2 ·VITEK(R) 2 GRAM POSITIVE AST FOR TRIMETHOPRIM/SULFAMETHOXAZOLE

Susceptibility Test Cards, Antimicrobial

FDA Pre-Market Approval

FDA Class 2 ·VITEK 2 GRAM NEGATIVE AST FOR AMOXICILLIN/CLAVULANIC ACID

PULSE OXIMETER

FDA 510(k)

FDA Class 2 ·Cardiovascular

WINCO STRETCHAIR

FDA 510(k)

FDA Class 2 ·Physical Medicine

MODEL 2500A PALMSAT PULSE OXIMETER

FDA 510(k)

FDA Class 2 ·Cardiovascular

Visby Medical Sexual Health Test

FDA 510(k)

FDA Class 2 ·Microbiology

INVOTEC POLY-MESH MANDIBULAR TRAY

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

H500 Multi-Sensing Oximetry System

FDA 510(k)

FDA Class 2 ·Cardiovascular

SenSmart Model 8203CA Regional Oximetry Sensor (Adult/Pediatric, >40 kg, SenSmart Model 820CA Regional Oximetry Sensor (Adult/Pediatric, >40 kg)

FDA 510(k)

FDA Class 2 ·Cardiovascular

INVOTEC MICROSCOPE DRAPE

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery