547 results · 23ms · Sources: EU EUDAMED, US FDA

QAB2A IGM ELISA KIT

FDA 510(k)
FDA Class 2 ·Immunology

RETINA TOMOGRAPH AND FLOWMETER

FDA 510(k)
FDA Class 2 ·Ophthalmic

RETINA FLOWMETER

FDA 510(k)
FDA Class 2 ·Ophthalmic

RETINA ANGIOGRAPH

FDA 510(k)
FDA Class 2 ·Ophthalmic

System, Nucleic Acid Amplification, Mycobacterium Tuberculosis Complex

FDA Pre-Market Approval
FDA Class 2 ·AMPLICOR MYCOBACTERIUM TUBERCULOSIS (MTB) TEST

System, Nucleic Acid Amplification, Mycobacterium Tuberculosis Complex

FDA Pre-Market Approval
FDA Class 2 ·AMPLICOR MYCOBACTERIUM TUBERCULOSIS (MTB) TEST

System, Nucleic Acid Amplification, Mycobacterium Tuberculosis Complex

FDA Pre-Market Approval
FDA Class 2 ·AMPLICOR MYCOBACTERIUM TUBERCULOSIS (MTB) TEST

MBI CO-AXIAL ILLUMINATED RETINAL PICK

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

MBI ILLUMINATED RETINAL PICK

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

MBI FIBEROPTIC ENDO-ILLUMINATOR

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

TSH MAB IRMA

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

Optional Screen Display for HeartSee Cardiac P.E.T. Processing Software - HeartSee version 3

FDA 510(k)
FDA Class 2 ·Radiology

Optional Screen Displays for HeartSee Cardiac P.E.T. Processing Software - HeartSee version 4

FDA 510(k)
FDA Class 2 ·Radiology

Rover

FDA 510(k)
FDA Class 2 ·Radiology

AMERLITE MAB FT4 ASSAY

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

CEDIA T4 MAB ASSAY

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

CEDIA T4 MAB ASSAY

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

COBAS INTEGRA AMIKACIN MAB

FDA 510(k)
FDA Class 2 ·Clinical Toxicology

CEDIA T4 MAB ASSAY

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

AMERLITE MAB FT4 ASSAY

FDA 510(k)
FDA Class 2 ·Clinical Chemistry