AMG MED BRAND CLINICAL GLASS THERMOMETER

FDA 510(k)

FDA Class 2 ·General Hospital

Models 2200DR and 1600DR Digital Stationary Radiographic Systems

FDA 510(k)

FDA Class 2 ·Radiology

VITEK2 AST-Gram Negative Delafloxacin (<=0.06->=4 ug/mL)

FDA 510(k)

FDA Class 2 ·Microbiology

BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - CEFTRIAXONE (STREP) 0.0625 - 4UG/ML

FDA 510(k)

FDA Class 2 ·Microbiology

BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM CEFEPIME (STREP) 0.0625-4UG/ML

FDA 510(k)

FDA Class 2 ·Microbiology

BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - ERYTHROMYCIN (STREP) 0.0156 - 4UG/ML

FDA 510(k)

FDA Class 2 ·Microbiology

ETEST Imipenem/Relebactam (IPR) (0.002/4-32/4 ug/mL)

FDA 510(k)

FDA Class 2 ·Microbiology

BD PHONIX AUTOMATED MICROBIOLOGY SYSTEM - CEFOTAXIME STREP (0.0625-4UG/ML)

FDA 510(k)

FDA Class 2 ·Microbiology

BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - CEFTAROLINE (0.625-4 UG/ML)

FDA 510(k)

FDA Class 2 ·Microbiology

BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - CEFUROXIME (STREP) 0.125 - 4UG/ML

FDA 510(k)

FDA Class 2 ·Microbiology

BD PHOENIX AUTOMATED MICROBIOLOGY SYSTESM - TIGECYCLINE (0.313-4UG/ML) GP

FDA 510(k)

FDA Class 2 ·Microbiology

Susceptibility Test Cards, Antimicrobial

FDA Pre-Market Approval

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

BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-MEROPENEM (STREP) 0.03125-2 UG/ML

FDA 510(k)

FDA Class 2 ·Microbiology

ETEST Piperacillin/Tazobactam (P/T) (0.016/4-256/4 ug/mL)

FDA 510(k)

FDA Class 2 ·Microbiology

BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - CLINDAMYCIN (STREP) 0.03125 -4 UG/ML

FDA 510(k)

FDA Class 2 ·Microbiology

AUTOMATIC DIGITAL BLOOD PRESSURE MONITOR

FDA 510(k)

FDA Class 2 ·Cardiovascular

Susceptibility Test Cards, Antimicrobial

FDA Pre-Market Approval

FDA Class 2 ·VITEK 2 GRAM POSITIVE AST FOR CIPROFLOXACIN

PROABLE PULSE OXIMETER, MODEL MD-600P, TRAVELER OXIMETER, MODEL MD-650P AND PALM PULSE OXIMETER, MODEL MD-680P

FDA 510(k)

FDA Class 2 ·Cardiovascular

MEDELA INVIA WOUND THERAPY

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

CARDIOVIT AT-102 G2

FDA 510(k)

FDA Class 2 ·Cardiovascular