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

Swoop Point-of-Care Magnetic Resonance Imaging (POC MRI) Scanner System

FDA 510(k)

FDA Class 2 ·Radiology

Poseidon Ultrasound System

FDA 510(k)

FDA Class 2 ·Radiology

SINGLE USE INSTRUMENT TRAY

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

MODEL 20 BIPOLAR COAGULATOR

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

QUANTA LITE INTRINSIC FACTOR ELISA

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

QUANTA FLASH PR3, QUANTA FLASH MPO, QUANTA FLASH GBM

FDA 510(k)

FDA Class 2 ·Immunology

DOLPHIN II FLUID MANAGEMENT SYSTEM, MODEL DOL-2

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

QUANTA FLASH RO60, QUANTA FLASH RO60 CALIBRATORS, QUANTA FLASH RO60 CONTROLS

FDA 510(k)

FDA Class 2 ·Immunology