SIMPEX INC. ORAL AND RECTAL THERMOMETERS

FDA 510(k)

FDA Class 2 ·General Hospital

QUANTA FLASH (TM) DGP SCREEN

FDA 510(k)

FDA Class 2 ·Immunology

Resolve 2.0

FDA 510(k)

FDA Class 2 ·Dental

NUVASIVE MASH

FDA 510(k)

FDA Class 2 ·Orthopedic

CorMatrix Cor Patch (3 cm x 5 cm)(single pack), CorMatrix Cor Patch (4 cm x 7 cm)(single pack), CorMatrix Cor Patch (7 cm x 10 cm)(single pack)

FDA 510(k)

FDA Class 2 ·Cardiovascular

NUVASIVE NEUROVISION JJB SYSTEM

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

QUANTA LITE SS-A 52 ELISA

FDA 510(k)

FDA Class 2 ·Immunology

MODIFICATION TO PROMAX-XP, TENS AND MICROCURRENT DEVICE; PROMAX-TENS, TENS DEVICE; PROMAX-LIBRA, TENS DEVICE; PROMAX-MIC

FDA 510(k)

FDA Class 2 ·Neurology

Vitamin D 200M Assay for the Topaz System

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

STERILE ISOTONIC SALINE & STERILE WATER

FDA 510(k)

FDA Class 2 ·General Hospital

NUVASIVE INS-1 INTRAOPERATIVE NERVE SURVEILLANCE SYSTEM

FDA 510(k)

FDA Class 2 ·Anesthesiology

STEREOTIX

FDA 510(k)

FDA Class 2 ·Radiology

QUANTA LITE GLIADIN IGG II

FDA 510(k)

FDA Class 2 ·Immunology

TITANIUM-HIP TOOL

FDA 510(k)

FDA Class 2 ·Orthopedic

PRIME ECG SYSTEM

FDA 510(k)

FDA Class 2 ·Cardiovascular

QUANTA Flash Calprotectin Reagents, QUANTA Flash Calprotectin Calibrators, QUANTA Flash Calprotectin Controls, QUANTA Flash Calprotectin Extraction Buffer

FDA 510(k)

FDA Class 2 ·Immunology

QUANTA FLASH RO52, QUANTA FLASH RO52 CALIBRATORS, AND QUANTA FLASH RO52 CONTROLS

FDA 510(k)

FDA Class 2 ·Immunology

QUANTA FLASH CENTROMERE

FDA 510(k)

FDA Class 2 ·Immunology

PRESTILIX 1690

FDA 510(k)

FDA Class 2 ·Radiology

QUANTA LITE CCP3 IGG ELISA

FDA 510(k)

FDA Class 2 ·Immunology