5,908 results · 46ms · Sources: EU EUDAMED, US FDA

STANDARD LipidoCare Home System

FDA registration
SD Biosensor, Inc.·4 products·🇰🇷 South Korea

CardioChek PA

FDA registration
Polymer Technology Systems·4 products·🇺🇸 United States

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval
FDA Class 3 ·SPRINT QUATTRO SECURE S SINGLE COIL IS-1/DF-1, ACTIVE FIX LEAD MODEL 6935

Alere Cholestech LDX®

FDA UDI
ALERE SAN DIEGO, INC.·00899722002337·Alere Cholestech LDX® Lipid Profile

Piccolo Lipid Panel

FDA UDI
ABAXIS, INC.·EABA40000251·The Piccolo® Lipid Panel reagent disc, used wit...

MAGNETIC HDL CHOLESTEROL TEST

FDA 510(k)
FDA Class 1 ·Clinical Chemistry

ICA PLASMA HDL AND LDL MEASUREMENT SYSTEM

FDA 510(k)
FDA Class 1 ·Clinical Chemistry

HDL CHOLESTEROL PRECIPITATING REAGENT

FDA 510(k)
FDA Class 1 ·Clinical Chemistry

HDL PRECIPITATING REAGENT

FDA 510(k)
FDA Class 1 ·Clinical Chemistry

HDL CHOLESTEROL REAGENT SET

FDA 510(k)
FDA Class 1 ·Clinical Chemistry

STAT TEST HDL/CHOLESTEROL TEST KIT

FDA 510(k)
FDA Class 1 ·Clinical Chemistry

COULTER HDL - CHOLESTEROL REAGENT

FDA 510(k)
FDA Class 1 ·Clinical Chemistry

HDL EX-SEP PRECIPITATING REAGENT

FDA 510(k)
FDA Class 1 ·Clinical Chemistry

ROCHE SEPARATING REAGENT FOR HDL CHOLESTEROL

FDA 510(k)
FDA Class 1 ·Clinical Chemistry

MTM BIOSCANNER HDL, MODEL # BSA450, BSA460, BSA470

FDA 510(k)
FDA Class 1 ·Clinical Chemistry

HDL CHOLESTEROL PRETREATMENT

FDA 510(k)
FDA Class 1 ·Clinical Chemistry

DIRECT HDL CHOLESTEROL AND DIRECT HDL/LDL CALIBRATOR

FDA 510(k)
FDA Class 1 ·Clinical Chemistry

ROCHE UNIMATE HDL DIRECT REAGEN (WITH POL CLAIM)

FDA 510(k)
FDA Class 1 ·Clinical Chemistry

HDL PRECIPITATING REAGENT (DEXTRAN SULFATE)

FDA 510(k)
FDA Class 1 ·Clinical Chemistry

HDL UNI-PAKS (PTA), CATALOGUE NUMBER 215-51

FDA 510(k)
FDA Class 1 ·Clinical Chemistry