16 results · 18ms · Sources: EU EUDAMED, US FDA

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PureWay Sharps Container 1-Gal, 2-Gal, 3-Gal (800011 800012, 800013)

FDA 510(k)
FDA Class 2 ·General Hospital

GAL-1E BLOOD GLUCOSE MONITORING SYSTEM GAL-1E BLOOD GLUCOSE TEST STRIPS GAL-1E MULTI BLOOD GLUCOSE MONITORING SYSTEM GAL

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

GAL-1C BLOOD GLUCOSE MONITORING SYSTEM, GAL-1C TEST STRIPS

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

IMMUCHEM GAL-MW EA

FDA 510(k)
FDA Class 1 ·Clinical Chemistry

GAL-PUT CONTROLS, NORMAL&DEFICIENT

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

ImmunoCAP Allergen o215, Component nGal-alpha-1,3-Gal(alpha-Gal) Thyroglobulin, bovine

FDA 510(k)
FDA Class 2 ·Immunology

GAL-1F Blood Glucose Monitoring System, GAL-1F Pro Blood Glucose Monitoring System

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

EASY LOOP, MODEL EZL-01

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

QUANTASE PHE/GAL SCREENING ASSAY

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

GAL-1A BLOOD GLUCOSE MONITORING SYSTEM

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

JETSTREAM G3 L SYSTEM MODEL PV31400 (JETSTREAM G3 L CATHETER WITH CONTROL POD); PVCN100 (PV CONSOLE)

FDA 510(k)
FDA Class 2 ·Cardiovascular

GAL-1A Plus Blood Glucose Monitoring System

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

JETSTREAM G3 L SYSTEM, PV CONSOLE, MODELS PV31400, PV31300, PVCN100

FDA 510(k)
FDA Class 2 ·Cardiovascular

JETSTREAM NAVITUS SYSTEM; JETSTREAM G3 SF SYSTEM; JETSTREAM G3 SE SYSTEM; JETSTREAM G3 L SYSTEM

FDA 510(k)
FDA Class 2 ·Cardiovascular

NOVEOS Specific IgE (sIgE): Capture Reagent F013, Peanut (Arachis hypogaea); Capture Reagent F076, Bos d 4 a-lactalbumin, Milk; Capture Reagent F077, Bos d 5 ß-lactoglobulin, Milk; Capture Reagent F232, Gal d 2 Ovalbumin, Egg

FDA 510(k)
FDA Class 2 ·Immunology

NOVEOS Specific IgE (sIgE); Capture Reagent F004, Wheat (Triticum aestivum); Capture Reagent F023, Crab (Callinectes spp.); Capture Reagent F079, Gluten, Wheat; Capture Reagent F202, Cashew Nut (Anacardium occidentale); Capture Reagent F233, Gal d 1 Ovomucoid Egg

FDA 510(k)
FDA Class 2 ·Immunology