VITEK 2 AST STREPTOCOCUS VANCOMYCIN

FDA 510(k)

FDA Class 2 ·Microbiology

VIDAS D-DIMER EXCLUSION II (DEX2)

FDA 510(k)

FDA Class 2 ·Hematology

VITEK 2 AST-Gram Negative Meropenem/Vaborbactam (<=0.5/8 – >=64/8 µg/mL)

FDA 510(k)

FDA Class 2 ·Microbiology

ARGYLE NEO-SERT HYDROPHILIC POLYURETHANE UMBILICAL VESSEL CATHETER INSERTION TRAY

FDA 510(k)

FDA Class 2 ·General Hospital

VITEK 2 AST-Gram Negative Imipenem (</=0.25->= 16 ug/mL)

FDA 510(k)

FDA Class 2 ·Microbiology

Lateral Plate System

FDA 510(k)

FDA Class 2 ·Orthopedic

VIDAS CEA (S) ASSAY

FDA 510(k)

FDA Class 2 ·Immunology

Vas-Q-Clip

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

SIGMA DIAGOSTIC ELECTROLYTE REFERENCE REAGENT

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

LA PLATA 40

FDA 510(k)

FDA Class 2 ·Dental

PORTABLE THERAPEUTIC LIQUID OXYGEN UNIT

FDA 510(k)

FDA Class 2 ·Anesthesiology

VIDAS TROPONIN I (TNI), MODEL 30 445

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

DENSICHECK PLUS

FDA 510(k)

FDA Class 2 ·Microbiology

MASTER NEB II

FDA 510(k)

FDA Class 2 ·Anesthesiology

VENTILATION TUBE. SILI. DONALDSON TYPE

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

MONOJECT(R) TRACE ELEMENT BLOOD COLLECTION TUBE

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

SIGMA DIAGNOSTICS ACCUCLOT CONTROL II

FDA 510(k)

FDA Class 2 ·Hematology

YOUNG PROPHY SYSTEM, PS UNIT

FDA 510(k)

FDA Class 2 ·Dental

GOLDEN GATE ANTERIOR PLATE SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

STORZ PREMIERE/PREMIERE MICROVIT MICROSURG SYSTEMS

FDA 510(k)

FDA Class 2 ·Ophthalmic