157 results · 35ms · Sources: EU EUDAMED, US FDA

Lunit INSIGHT MMG

FDA 510(k)
FDA Class 2 ·Radiology

Lunit INSIGHT CXR Triage

FDA 510(k)
FDA Class 2 ·Radiology

Lunit INSIGHT DBT

FDA 510(k)
FDA Class 2 ·Radiology

Lunit INSIGHT DBT v1.1

FDA 510(k)
FDA Class 2 ·Radiology

Lenses, Soft Contact, Daily Wear

FDA Pre-Market Approval
FDA Class 2 ·TRESOFT OCUFILCON SOFT HYDROPHILIC CONTACT LENS

Lenses, Soft Contact, Daily Wear

FDA Pre-Market Approval
FDA Class 2 ·TRESOFT OCUFILCON SOFT HYDROPHILIC CONTACT LENS

Lenses, Soft Contact, Daily Wear

FDA Pre-Market Approval
FDA Class 2 ·TRESOFT OCUFILCON SOFT HYDROPHILIC CONTACT LENS

Lenses, Soft Contact, Daily Wear

FDA Pre-Market Approval
FDA Class 2 ·TRESOFT OCUFILCON SOFT HYDROPHILIC CONTACT LENS

UBI MAGIWEL(TM) ANTI-DS-DNA QUANTITATIVE

FDA 510(k)
FDA Class 2 ·Immunology

UBI MAGIWEL(TM) ANA QUANTITATIVE

FDA 510(k)
FDA Class 2 ·Immunology

UBI MAGIWEL MARIJUANA METABOLITES

FDA 510(k)
FDA Class 2 ·Clinical Toxicology

UNITED SONICS PHACO MODULE, DF-35

FDA 510(k)
FDA Class 2 ·Ophthalmic

BLOOD GAS ANALYSIS, STANDARDS CONTROLS

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

UBI MAGIWEL CORTISOL QUANTITATIVE

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

AMPULED FLAME PHOTOMETER STANDARDS

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

CO-OXIMETER CONTROL

FDA 510(k)
FDA Class 2 ·Hematology

UBI MAGIWEL OPIATE METABOLITES

FDA 510(k)
FDA Class 2 ·Clinical Toxicology

UBI MAGIWEL COCAINE METABOLITES

FDA 510(k)
FDA Class 2 ·Clinical Toxicology

UBI MAGIWEL FERRITIN QUANTITATIVE

FDA 510(k)
FDA Class 2 ·Immunology

UBI MAGIWEL THYROXINE (T4) QUANTITATIVE

FDA 510(k)
FDA Class 2 ·Clinical Chemistry