460 results · 26ms · Sources: EU EUDAMED, US FDA

ELECSYS HE4, ELECSYS HE4 CALSET, ELECSYS PRECICONTROL HE4, ELECSYS HE4 CALCHECK 5

FDA 510(k)
FDA Class 2 ·Immunology

ARCHITECT HE4, ARCHITECT HE4 CALIBRATORS AND ARCHITECT HE4 CONTROLS, MODELS 2, 2P54, 2P54-01, 2P54-10 SP54-01,

FDA 510(k)
FDA Class 2 ·Immunology

HE4 EIA, MODEL: 404-10 US

FDA 510(k)
FDA Class 2 ·Immunology

FUJIREBIO DIAGNOSTICS TUMOR MARKER CONTROL

FDA 510(k)
FDA Class 2 ·Immunology

Lumipulse G HE4 Immunoreaction Cartridges, Lumipulse G HE4 Calibrators

FDA 510(k)
FDA Class 2 ·Immunology

Test, Epithelial Ovarian Tumor Associated Antigen (He4)

FDA classification
FDA Class 2 ·Test, Epithelial Ovarian Tumor Associated Antigen (He4)

AXSYM BARBITURATES II U

FDA 510(k)
FDA Class 2 ·Clinical Toxicology

WACKERS-LIU CQ SOFTWARE

FDA 510(k)
FDA Class 2 ·Radiology

MODIFICARION TO WACKERS-LIU CQ SOFTWARE

FDA 510(k)
FDA Class 2 ·Radiology

DBEST HCG 2 IU/ML TEST KIT

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

Lenses, Soft Contact, Daily Wear

FDA Pre-Market Approval
FDA Class 2 ·OCU-FLEX

Lenses, Soft Contact, Daily Wear

FDA Pre-Market Approval
FDA Class 2 ·OCU-FLEX

CLINICAL ELECTRONIC THERMOMETER

FDA 510(k)
FDA Class 2 ·General Hospital

KAISHOU VAGINAL SPECULUM

FDA 510(k)
FDA Class 2 ·Obstetrics/Gynecology

Pressure Therapy System

FDA 510(k)
FDA Class 2 ·Physical Medicine

Pressure Therapy System PT1003

FDA 510(k)
FDA Class 2 ·Physical Medicine

Pressure Therapy System PT1003

FDA 510(k)
FDA Class 2 ·Physical Medicine

Lenses, Soft Contact, Daily Wear

FDA Pre-Market Approval
FDA Class 2 ·OCU-FLEX-53 SOFT CONTACT LENSES

WAKO LBA DCP TEST SYSTEM, MODEL 993-05301; DCP CONTROL SET, MODEL 995-0551; DCP CALIBRATOR SET, LIBASYS, MODEL 999-05401

FDA 510(k)
FDA Class 2 ·Immunology

OCU-FLEX 55 SPHERICAL, TORIC,THIN ZONE TORIC,ASPHERICAL,TORIC ASPHERICAL AND THIN ZONE TORIC ASPHERICAL (METHAFILCON A)S

FDA 510(k)
FDA Class 2 ·Ophthalmic