Anterion

FDA 510(k)

FDA Class 2 ·Ophthalmic

Anterion

FDA 510(k)

FDA Class 2 ·Ophthalmic

SPECTRALIS with Flex Module

FDA 510(k)

FDA Class 2 ·Ophthalmic

Unyvero LRT BAL Application

FDA 510(k)

FDA Class 2 ·Microbiology

Leica FL400

FDA 510(k)

FDA Class 2 ·Neurology

Spectralis HRA+OCT and variants with OCT Angiography Module

FDA 510(k)

FDA Class 2 ·Ophthalmic

Spectralis HRA+OCT and variants with High Magnification Module

FDA 510(k)

FDA Class 2 ·Ophthalmic

Spectralis HRA + OCT and variants

FDA 510(k)

FDA Class 2 ·Ophthalmic

PAPCONE

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

BD MAX CTGCTV2, BD MAX System

FDA 510(k)

FDA Class 2 ·Immunology

H-MAX S Femoral Hip System

FDA 510(k)

FDA Class 2 ·Orthopedic

Luminos dRF Max, Luminos Agile Max, Uroskop Omnia Max, Multitom Rax

FDA 510(k)

FDA Class 2 ·Radiology

X TWIN SYSTEM

FDA 510(k)

FDA Class 2 ·Radiology

BD MAX Vaginal Panel, BD MAX Instrument

FDA 510(k)

FDA Class 2 ·Microbiology

BD MAX CDIFF ASSAY, BD MAX INSTRUMENT

FDA 510(k)

FDA Class 2 ·Microbiology

Deltaven XiV Max, Deltaven XiV Max FF

FDA 510(k)

FDA Class 2 ·General Hospital

BD MAX MRSA ASSAY, BD MAX INSTRUMENT

FDA 510(k)

FDA Class 2 ·Microbiology

BD MAX MRSA XT, BD MAX INSTRUMENT

FDA 510(k)

FDA Class 2 ·Microbiology

LEVO MAX

FDA 510(k)

FDA Class 2 ·Physical Medicine

MAX-ACT

FDA 510(k)

FDA Class 2 ·Hematology