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

STORZ DIAGNOSTIC MICROSCOPE SYSTEM

FDA 510(k)

FDA Class 1 ·General, Plastic Surgery

GRID/RADIOGRAPHIC

FDA 510(k)

FDA Class 1 ·Radiology

DISPOSABLE INFUSION CANNULA 0045-1/2/3 2.5/4.0/6.0

FDA 510(k)

FDA Class 1 ·Ophthalmic

PRISMA DISPOSABLE ATKINSON RETROBULBAR NEEDLE

FDA 510(k)

FDA Class 1 ·Ophthalmic

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

SUNGLASS FRAME

FDA 510(k)

FDA Class 1 ·Ophthalmic

Lateral Plate System

FDA 510(k)

FDA Class 2 ·Orthopedic

IMA-TROL IMMUNOASSAY CONTROL

FDA 510(k)

FDA Class 1 ·Clinical Chemistry

PRISMA DISPOSABLE IRRIGATING IRIS HOOK

FDA 510(k)

FDA Class 1 ·Ophthalmic

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

GENERAL SURGICAL FILES

FDA 510(k)

FDA Class 1 ·General, Plastic Surgery

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