10,000 results · 159ms · Sources: EU EUDAMED, US FDA

Hepatitis Viral B Dna Detection

FDA Pre-Market Approval
FDA Class 3 ·Roche CBAS TaqMan HBV Test, v2.0

Somatic Gene Mutation Detection System

FDA Pre-Market Approval
FDA Class 3 ·RealTime IDH1

Somatic Gene Mutation Detection System

FDA Pre-Market Approval
FDA Class 3 ·cobas BRAF V600 Mutation Test

Assay, Hybridization And/Or Nucleic Acid Amplification For Detection Of Hepatitis C Rna,Hepatitis C Virus

FDA Pre-Market Approval
FDA Class 2 ·cobas HCV

Somatic Gene Mutation Detection System

FDA Pre-Market Approval
FDA Class 3 ·RealTime IDH2

Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)

FDA Pre-Market Approval
FDA Class 3 ·ARCHITECT AUSAB

Implanted Electrical Device Intended For Treatment Of Fecal Incontinence

FDA Pre-Market Approval
FDA Class 3 ·InterStim Therapy System and Verify Evaluation System (SNS Bowel)

Hepatitis Viral B Dna Detection

FDA Pre-Market Approval
FDA Class 3 ·COBAS TaqMan HBV Test for Use with the High Pure System and COBAS AmpliPrep/COBAS TaqMan HBV Test, v2.0

INDICAID™ HCG EARLY RESULT PREGNANCY TEST STRIP

FDA registration
Phase Scientific (Shenzhen) Company Limited·2 products·🇨🇳 China

EV29L Sterile Biopsy Needle Guide

FDA registration
EXACT IMAGING, INC.·3 products·🇨🇦 Canada

FOURSTAR GROUP INC.

FDA registration
FOURSTAR GROUP INC.·2 products·🇹🇼 Taiwan

VeriClear

FDA registration
TRUE DIAGNOSTICS, INC.·2 products·🇺🇸 United States

Pregnancy Test Kit

FDA registration
DELTA INTERNATIONAL TRADE ASIA PACIFIC LTD.·2 products·🇭🇰 Hong Kong

LUMIQUICK DIAGNOSTICS, INC.

FDA registration
LUMIQUICK DIAGNOSTICS, INC.·2 products·🇺🇸 United States

E-Cath STIM Tsui

FDA registration
PAJUNK GMBH MEDIZINTECHNOLOGIE·3 products·🇩🇪 Germany

PREG-Q Pregnancy Test

FDA registration
YD DIAGNOSTICS·2 products·🇰🇷 South Korea

VeriClear

FDA registration
TRUE DIAGNOSTICS, INC.·2 products·🇺🇸 United States

HCG Home Use Pregnancy Test Strip (Colloidal Gold)

FDA registration
ANHUI DEEPBLUE MEDICAL TECHNOLOGY CO., LTD.·2 products·🇨🇳 China

Mosie Baby Pregnancy Test

FDA registration
MOSIE INC·2 products·🇺🇸 United States

Ovulation and Pregnancy Test + Track Set

FDA registration
FRIDABABY, LLC·2 products·🇺🇸 United States