96 results · 20ms · Sources: EU EUDAMED, US FDA

COSMED K4

FDA 510(k)
FDA Class 2 ·Anesthesiology

Gynethotics™ Pessary

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

COSMED QUARK

FDA 510(k)
FDA Class 2 ·Anesthesiology

QUARK SERIES

FDA 510(k)
FDA Class 2 ·Anesthesiology

VIDAS LYME IGG

FDA 510(k)
FDA Class 2 ·Microbiology

VIDAS LYME IGM

FDA 510(k)
FDA Class 2 ·Microbiology

VIDAS NEPHROCHECK

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

ETEST Fosfomycin (FO) (0.032-512 µg/mL)

FDA 510(k)
FDA Class 2 ·Microbiology

ETEST Eravacycline (ERV) (0.002 – 32 µg/mL)

FDA 510(k)
FDA Class 2 ·Microbiology

Avicenna Roboflex

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

NICU V'02

FDA 510(k)
FDA Class 2 ·Anesthesiology

COOMASSIE BLUE TOTAL PROTEIN ASSAY KIT

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

Precision Flow® HVNI

FDA 510(k)
FDA Class 2 ·Anesthesiology

HEMOGLOBIN A2 MICRO COLUMN TEST

FDA 510(k)
FDA Class 2 ·Hematology

TISSUELINK AQUAMANTYS MALLEABLE BIPOLAR SEALER WITH LIGHT

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

APOLONIA LASER IMPLANT SYSTEM

FDA 510(k)
FDA Class 2 ·Dental

QMAPP Amplifier; QMAPP Hemodynamic Monitoring System; QMAPP PCM; QMAPP GO; QMAPP EP

FDA 510(k)
FDA Class 2 ·Cardiovascular

CERVEX-BRUSH COMBI

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

Catheter, Electrode Recording, Or Probe, Electrode Recording

FDA Pre-Market Approval
FDA Class 2 ·NAVISTAR DEFLECTABLE TIP DIAGNOSTIC/ABLATION CATHETER

Catheter, Electrode Recording, Or Probe, Electrode Recording

FDA Pre-Market Approval
FDA Class 2 ·NAVISTAR DEFLECTABLE TIP DIAGNOSTIC/ABLATION CATHETER