SIGMA DIAGNOSTICS INFINITY URIC ACID REAGENT KIT

FDA 510(k)

FDA Class 1 ·Clinical Chemistry

NEXT GENERATION PORTABLE THERAPEUTIC LIQUID OXYGEN SYSTEM

FDA 510(k)

FDA Class 2 ·Anesthesiology

VITEK 2 GRAM POSITIVE VANCOMYCIN

FDA 510(k)

FDA Class 2 ·Microbiology

SIGMA DIAGNOSTICS SIGMA-CAL, MODEL S2936

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY CATHETER

FDA 510(k)

FDA Class 2 ·Cardiovascular

Premier Resolution System

FDA 510(k)

FDA Class 2 ·Hematology

Niobe® Magnetic Navigation System (MNS) with Navigant Workstation (NWS) and Cardiodri

FDA 510(k)

FDA Class 2 ·Cardiovascular

SHILEY TRACHEOSOFT XLT EXTENDED LENGTH TRACHEOSTOMY TUBE AND DISPOSABLE INNER CANNULA

FDA 510(k)

FDA Class 2 ·Anesthesiology

Restrata Soft Tissue Reinforcement (STR)

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

WHITESIDE BIOMECHANICS ZIRCONIA CERAMIC FEMORAL HEAD

FDA 510(k)

FDA Class 2 ·Orthopedic

LA PLATA 34 (PM-25)

FDA 510(k)

FDA Class 2 ·Dental

PRISMA DISPOSABLE BLUNT IRRIGATING CYSTOTOME

FDA 510(k)

FDA Class 1 ·Ophthalmic

PRIMUS RAPID GEL 100 GLYCATED HEMOGLOBIN ASSAY

FDA 510(k)

FDA Class 2 ·Hematology

ODYSSEY WORKSTATION

FDA 510(k)

FDA Class 2 ·Cardiovascular

VITEK 2 GRAM NEGATIVE PIPERACILLIN

FDA 510(k)

FDA Class 2 ·Microbiology

PEMACO ECONOMY BASE PLATE WAX-MEDIUM HARD

FDA 510(k)

FDA Class 1 ·Dental

PHENYTOIN FPIA REAGENT SET AND CALIBRATORS

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

uCerv Flux-C 3D Porous Titanium Cervical Interbody

FDA 510(k)

FDA Class 2 ·Orthopedic

GRAM NEGATIVE IDENTIFICATION PLUS CARD

FDA 510(k)

FDA Class 1 ·Microbiology

STAGE ZERO AIR FLOTATION BED

FDA 510(k)

FDA Class 2 ·Physical Medicine