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

FDA 510(k)

FDA Class 2 ·Microbiology

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

ShurFit Lumbar Interbody System

FDA 510(k)

FDA Class 2 ·Orthopedic

SPINAL USA VBR SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

Precision Spine Interspinous Plate System

FDA 510(k)

FDA Class 2 ·Orthopedic

SMARTDOP 20 BI-DIRECTIONAL BLOOD FLOW DETECTOR

FDA 510(k)

FDA Class 2 ·Cardiovascular

STORZ DP4101 BASIC I/A PACK

FDA 510(k)

FDA Class 2 ·Ophthalmic

SHILEY CUFFED PEDIATRIC TRACHEOSTOMY TUBE; LONG CUFFED

FDA 510(k)

FDA Class 2 ·Anesthesiology

STORZ PROTEGE OPTHALMIC MICROSURGICAL SYSTEM

FDA 510(k)

FDA Class 2 ·Ophthalmic

VITEK 2 AST-GN Tigecycline (<0.5->8 ug/mL)

FDA 510(k)

FDA Class 2 ·Microbiology

TOTAL T4 FPIA REAGENT SET/CALIBRATOR #T-1039,T-116

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

VITEK 2 AST ST MEROPENEM

FDA 510(k)

FDA Class 2 ·Microbiology

VITEK 2 GRAM POSITIVE MEROPENEM

FDA 510(k)

FDA Class 2 ·Microbiology

ZAVATION CERVICAL PLATE SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

GLUCOSE(TRINDER) REAGENT

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

VITEK GRAM POSITIVE SUSCEPTIBILITY (GPS) CARD FOR ERTAPENEM

FDA 510(k)

FDA Class 2 ·Microbiology

COMPCORE AF COMPOSITE CORE BUILD-UP MATERIAL, MODEL 3001408

FDA 510(k)

FDA Class 2 ·Dental

Reform Pedicle Screw System

FDA 510(k)

FDA Class 2 ·Orthopedic

VIDAS TBI (GFAP, UCH-L1)

FDA 510(k)

FDA Class 2 ·Immunology