VANNA BATHING SYSTEM

FDA 510(k)

FDA Class 2 ·Physical Medicine

CIRCUFLOW 5200 SEQUENTIAL COMPRESSION DEVICE

FDA 510(k)

FDA Class 2 ·Cardiovascular

eCordum Cardiac Monitor (eCordum CM)

FDA 510(k)

FDA Class 2 ·Cardiovascular

NovaCross CTO Microcatheter

FDA 510(k)

FDA Class 2 ·Cardiovascular

SignalNED System (Model RE)

FDA 510(k)

FDA Class 2 ·Neurology

Susceptibility Test Cards, Antimicrobial

FDA Pre-Market Approval

FDA Class 2 ·VITEK(R) 2 GRAM POSITIVE AST FOR ERYTHROMYCIN

Susceptibility Test Cards, Antimicrobial

FDA Pre-Market Approval

FDA Class 2 ·VITEK(R) 2 GRAM POSITIVE AST FOR MINOCYCLINE

Susceptibility Test Cards, Antimicrobial

FDA Pre-Market Approval

FDA Class 2 ·VITEK 2 GRAM POSITIVE AST FOR AMPICILLIN/SULBACTAM

Susceptibility Test Cards, Antimicrobial

FDA Pre-Market Approval

FDA Class 2 ·VITEK 2 GRAM NEGATIVE AST FOR TRIMETHOPRIM/SULFAMETHOXAZOLE

Susceptibility Test Cards, Antimicrobial

FDA Pre-Market Approval

FDA Class 2 ·VITEK 2 GRAM NEGATIVE AST FOR PIPERACILLIN/TAZOBACTAM

Susceptibility Test Cards, Antimicrobial

FDA Pre-Market Approval

FDA Class 2 ·VITEK(R) 2 GRAM POSITIVE AST FOR CEFAZOLIN

Susceptibility Test Cards, Antimicrobial

FDA Pre-Market Approval

FDA Class 2 ·VITEK(R) 2 GRAM NEGATIVE AST FOR IMIPENEM

Susceptibility Test Cards, Antimicrobial

FDA Pre-Market Approval

FDA Class 2 ·VITEK 2 GRAM NEGATIVE AST FOR NALIDIXIC ACID

Susceptibility Test Cards, Antimicrobial

FDA Pre-Market Approval

FDA Class 2 ·VITEX 2 GRAM NEGATIVE AST FOR AMPICILLIN/SULBACTAM

CASTLE 7515 UTENSIL/GLASSWARE WASHER

FDA 510(k)

FDA Class 2 ·General Hospital

Cenorin 610 Washer-Pasteurizers/High Level Disinfector and Cenorin 610HT Washer-Pasteurizers/High Level Disinfector

FDA 510(k)

FDA Class 2 ·General Hospital

IN-VITRO TEST DETERMINATION OF SGOT (AST)

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

DECOMAT 4656

FDA 510(k)

FDA Class 2 ·General Hospital

ELVI SGOT & SGPT TRANSAMINASE

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

SERALYZER AST/SGOT REAGENT STRIPS

FDA 510(k)

FDA Class 2 ·Clinical Chemistry