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

T2Candida 1.1 Panel

FDA 510(k)
FDA Class 2 ·Microbiology

T2CANDIDA AND T2DX INSTRUMENT

FDA 510(k)
FDA Class 2 ·Microbiology

T2Candida 1.1 Panel

FDA 510(k)
FDA Class 2 ·Microbiology

Candida Species Nucleic Acid Detection System

FDA classification
FDA Class 2 ·Candida Species Nucleic Acid Detection System

ELECSYSCA 15-3 II ASSAY

FDA 510(k)
FDA Class 2 ·Immunology

Elecsys CA 15-3 II

FDA 510(k)
FDA Class 2 ·Immunology

Elecsys CA 15-3 II

FDA 510(k)
FDA Class 2 ·Immunology

EQUIDOSE SOLID STATE DIODE DETECTORS

FDA 510(k)
FDA Class 2 ·Radiology

SONICEYE ULTRASOUND TRANSDUCER

FDA 510(k)
FDA Class 2 ·Radiology

SUCTION LIPOLASTY ACCESSORIES

FDA 510(k)
FDA Class 2 ·General, Plastic Surgery

FLEXSURE OBT

FDA 510(k)
FDA Class 2 ·Hematology

GAMBRO MULTIPURPOSE SYSTEM MPS-10

FDA 510(k)
FDA Class 2 ·Gastroenterology, Urology

HEMOFILTRATION SYSTEM 10

FDA 510(k)
FDA Class 2 ·Gastroenterology, Urology

COTRAL I W/4.5 L/HR. ULTRAFILTRAT. CAPA

FDA 510(k)
FDA Class 2 ·Gastroenterology, Urology

HEMODIALYSIS (SPS), MODEL 550, CODE 5M1309

FDA 510(k)
FDA Class 2 ·Gastroenterology, Urology

NXSTAGE SYSTEM ONE

FDA 510(k)
FDA Class 2 ·Gastroenterology, Urology

MiiS Horus Eye Anterior Camera

FDA 510(k)
FDA Class 2 ·Ophthalmic

VersaVue Single-Use Flexible Cystoscope, VersaVue Tablet, and VersaVue Video Box

FDA 510(k)
FDA Class 2 ·Gastroenterology, Urology

MiiS Horus Scope DPT 100

FDA 510(k)
FDA Class 2 ·Ophthalmic

ENT Nasopharyngoscope and Accessories

FDA 510(k)
FDA Class 2 ·Ear, Nose, Throat