VITEK 2 AST-Yeast Anidulafungin (<= 0.015 - >= 8 µg/mL)

FDA 510(k)

FDA Class 2 ·Microbiology

APEEL CS CATHETER DELIVERY SYSTEM

FDA 510(k)

FDA Class 2 ·Cardiovascular

MINIPAC (TM)

FDA 510(k)

FDA Class 2 ·Neurology

MODIFIED QM300 RHEUMATOID FACTOR TEST

FDA 510(k)

FDA Class 2 ·Immunology

TORQUE DEVICE

FDA 510(k)

FDA Class 2 ·Cardiovascular

Zimmer Virage OCT Spinal Fixation System

FDA 510(k)

FDA Class 2 ·Orthopedic

INFINITY HBA KIT, MODELS 537-A, 537-B

FDA 510(k)

FDA Class 2 ·Hematology

THORA-DRAIN(R) ABT SYSTEM

FDA 510(k)

FDA Class 2 ·Anesthesiology

INCSTAR'S PIGWEED ALLERGEN DISC

FDA 510(k)

FDA Class 2 ·Immunology

GLUCO TRACK BLOOD GLUCOSE MONITORING SYSTEM

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

SKINTACT

FDA 510(k)

FDA Class 2 ·Cardiovascular

ENDOMEDICAL TECHNOLOGIES QUIK-COVER FLEXIBLE ENDOSCOPE BARRIER SHEATH FOR OTOLARYNGOSCOPES AND BRONCHOSCOPES

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

HEPARIN DOSE RESPONSE CARTRIDGE

FDA 510(k)

FDA Class 2 ·Hematology

LAVA ULTIMATE CAD/CAM RESTORATIVE FOR CEREC / E4D, LAVA ULTIMATE IMPLANT CROWN RESTORATIVE

FDA 510(k)

FDA Class 2 ·Dental

PULMONE MINIBOXPFT 2.0

FDA 510(k)

FDA Class 2 ·Anesthesiology

MINNE TIES MMF Suture System

FDA 510(k)

FDA Class 2 ·Dental

Tubing Pack

FDA 510(k)

FDA Class 2 ·Cardiovascular

Citryte

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

KALLESTAD QUANTAFLUOR ANTITHYROID ANTIBODY TEST

FDA 510(k)

FDA Class 2 ·Immunology

Tubing Pack

FDA 510(k)

FDA Class 2 ·Cardiovascular