1,224 results · 25ms · Sources: EU EUDAMED, US FDA

PROADENO+ ASSAY

FDA 510(k)
FDA Class 2 ·Microbiology

PROGASTRO SSCS ASSAY

FDA 510(k)
FDA Class 2 ·Microbiology

INSTANT-X, MODELS 1713 & 128

FDA 510(k)
FDA Class 2 ·Radiology

PROPARAFLU+ ASSAY

FDA 510(k)
FDA Class 2 ·Microbiology

LIF-O-GEN #3000 OXYGEN CONCENTRATOR

FDA 510(k)
FDA Class 2 ·Anesthesiology

PRO HMPV+ ASSAY

FDA 510(k)
FDA Class 2 ·Microbiology

System, Nucleic Acid Amplification, Mycobacterium Tuberculosis Complex

FDA Pre-Market Approval
FDA Class 2 ·GEN-PROBE ABPLIFIED MYCOBACTERIUM TUBERCULOSIS DIRECT TEST

System, Nucleic Acid Amplification, Mycobacterium Tuberculosis Complex

FDA Pre-Market Approval
FDA Class 2 ·GEN-PROBE AMPLIFIED MYCOBACTERIUM TUBERCULOSIS DIRECT TEST

GEN. DIAG. CHROMOSTRATE REF. PLASMA

FDA 510(k)
FDA Class 2 ·Hematology

ONLINE TDM Vancomycin Gen.3

FDA 510(k)
FDA Class 2 ·Clinical Toxicology

TINA-QUANT FERRITIN GEN. 4

FDA 510(k)
FDA Class 2 ·Immunology

GEN-X 800/6/50

FDA 510(k)
FDA Class 2 ·Radiology

BEL-GEN Cold Storage Solution

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

PERF-GEN Pulsatile Perfusion Solution

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

GEN. DIAGNOSTICS LOW FIBRINOGEN CONTROL

FDA 510(k)
FDA Class 2 ·Hematology

TINA-QUANT IGG GEN.2

FDA 510(k)
FDA Class 2 ·Immunology

TINA-QUANT ALBUMIN GEN.2

FDA 510(k)
FDA Class 2 ·Immunology

PERF-GEN PULSATILE PERFUSION SOLUTION

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

Elecsys Troponin T Gen 5

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

GEN-X 800-400 -- MODIFICATION

FDA 510(k)
FDA Class 2 ·Radiology