812 results · 25ms · Sources: EU EUDAMED, US FDA

MICROPLEX COIL SYSTEMS (MCS)

FDA 510(k)
FDA Class 2 ·Neurology

Device, Neurovascular Embolization

FDA classification
FDA Class 2 ·Device, Neurovascular Embolization

HYDRO2, HS-75

FDA 510(k)
FDA Class 2 ·Ophthalmic

CLEARFIL REPAIR

FDA 510(k)
FDA Class 2 ·Dental

DIFCO DIRECTOR INOCULATION SYSTEM

FDA 510(k)
FDA Class 2 ·Microbiology

MicroScan Prompt Inoculation System-D

FDA 510(k)
FDA Class 2 ·Microbiology

SENSITITRE AIM (TM)

FDA 510(k)
FDA Class 2 ·Microbiology

THE SENSITITRE AIM

FDA 510(k)
FDA Class 2 ·Microbiology

TURBIDOMETRIC STANDARD

FDA 510(k)
FDA Class 2 ·Microbiology

SENSI-CAL AMCO AEPA-1

FDA 510(k)
FDA Class 2 ·Microbiology

PROMPT INOCULATION SYSTEM

FDA 510(k)
FDA Class 2 ·Microbiology

VITEK 2 YEAST CASPOFUNGIN

FDA 510(k)
FDA Class 2 ·Microbiology

VITEK 2 AST-YS Caspofungin <=0.125 - >=8 ug/mL

FDA 510(k)
FDA Class 2 ·Microbiology

VITEK 2 AST-Yeast Voriconazole (<= 0.03125 - >= 4 µg/mL)

FDA 510(k)
FDA Class 2 ·Microbiology

SENSITITRE YEASTONE SUSCEPTIBILITY PLATES- ADDITIONAL ANTIMICROBICS

FDA 510(k)
FDA Class 2 ·Microbiology

Sensititre YeastOne Susceptibility System with Fluconazole in the dilution range of 0.12-128ug/mL

FDA 510(k)
FDA Class 2 ·Microbiology

VITEK 2 AST-YS Micafungin (<=0.06 - =>8 µg/mL)

FDA 510(k)
FDA Class 2 ·Microbiology

MODIFICATION TO SENSITITRE YEASTONE MIC SUSCEPTIBILITY TEST

FDA 510(k)
FDA Class 2 ·Microbiology

VITEK 2 AST YS FLUCYTOSINE, VITEK 2 AST YEAST FLUCYTOSINE

FDA 510(k)
FDA Class 2 ·Microbiology

The Sensititre YeastOne Susceptibility System with Rezafungin in the dilution range of 0.008-8ug/mL

FDA 510(k)
FDA Class 2 ·Microbiology