450 results · 32ms · Sources: EU EUDAMED, US FDA

CYFRA 21-1 EIA MODEL 211-10

FDA 510(k)
FDA Class 2 ·Immunology

Elecsys CYFRA 21-1, Elecsys CYFRA 21-1 CalSet, PreciControl Tumor Marker

FDA 510(k)
FDA Class 2 ·Immunology

Kit, Test,Alpha-Fetoprotein For Testicular Cancer

FDA Pre-Market Approval
FDA Class 2 ·ABBOTT AFP-EIA DIAGNOSTIC KIT FOR NTDS

Kit, Test,Alpha-Fetoprotein For Testicular Cancer

FDA Pre-Market Approval
FDA Class 2 ·ABBOTT AFP-EIA DIAGNOSTIC KIT FOR CANCER

Kit, Test,Alpha-Fetoprotein For Testicular Cancer

FDA Pre-Market Approval
FDA Class 2 ·ABBOTT AFP-EIA DIAGNOSTIC KIT FOR CANCER

Kit, Test,Alpha-Fetoprotein For Testicular Cancer

FDA Pre-Market Approval
FDA Class 2 ·ABBOTT AFP-EIA DIAGNOSTIC KIT FOR CANCER

Maxcon Sharps Container

FDA 510(k)
FDA Class 2 ·General Hospital

Maxcon Two Gallon Chemotherapy Container

FDA 510(k)
FDA Class 2 ·General Hospital

Handheld VitalSigns Monitoring System

FDA 510(k)
FDA Class 2 ·Cardiovascular

Infrared Thermometer (Model: LX-26E, LX-260TE, PRO LX-261E, LX-360, LX-361T, BW-CX10)

FDA 510(k)
FDA Class 2 ·General Hospital

Hepatitis A Test (Antibody And Igm Antibody)

FDA Pre-Market Approval
FDA Class 2 ·ABBOTT HAVAB-M/HAVAB-M EIA/IMX HAVAB-M

LUNAR IDXA

FDA 510(k)
FDA Class 2 ·Radiology

GE LOGIQ E9 DIAGNOSTIC ULTRASOUND SYSTEM, MODELS 5205000, 5205000-2

FDA 510(k)
FDA Class 2 ·Radiology

GE LOGIQ 7 ULTRASOUND BT04

FDA 510(k)
FDA Class 2 ·Radiology

GE LUNAR DPX & PRODIGY SERIES DEXA BONE DENSITOMETERS WITH MOBILE KIT

FDA 510(k)
FDA Class 2 ·Radiology

GE LUNAR VISCERAL FAT SOFTWARE

FDA 510(k)
FDA Class 2 ·Radiology

GE LUNAR FEMUR STRENGTH SOFTWARE

FDA 510(k)
FDA Class 2 ·Radiology

GE LOGIQ BT08 DIAGNOSTIC ULTRASOUND SYSTEM

FDA 510(k)
FDA Class 2 ·Radiology

Hepatitis A Test (Antibody And Igm Antibody)

FDA Pre-Market Approval
FDA Class 2 ·ABBOTT IMX(R) HAVAB(R)-M

GALEMED PEAK FLOW METER, MODELS 3751/3752

FDA 510(k)
FDA Class 2 ·Anesthesiology