3,515 results · 38ms · Sources: EU EUDAMED, US FDA

StarCeram® Z-Nature, StarCeram® Z-Smile

FDA 510(k)
FDA Class 2 ·Dental

IN THE EAR HEARING AID

FDA 510(k)
FDA Class 1 ·Ear, Nose, Throat

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

FDA Pre-Market Approval
FDA Class 3 ·ADVIA CENTAUR HBC TOTAL READYPACK REAGENTS AND ADVIA CENTAUR HBC TOTAL QUALITY CONTROL MATERIALS

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

FDA Pre-Market Approval
FDA Class 3 ·ELECSYS ANTI-HBC IGM IMMUNOASSAY & ELECSYS PREICONTROL ANTI-HBC IGM FOR USE ON THE MODULAR ANAYTICS E170 IMMUNOASSAY ANA

Wondfo Methamphetamine Urine Test (MET 300)

FDA registration
GUANGZHOU WONDFO BIOTECH CO., LTD.·2 products·🇨🇳 China

VERDICT-II

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

Accusign MET

FDA registration
PRINCETON BIOMEDITECH CORP.·2 products·🇺🇸 United States

Wondfo Methamphetamine Urine Test (MET 300)

FDA registration
GUANGZHOU WONDFO BIOTECH CO., LTD.·2 products·🇨🇳 China

VERDICT-II

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

Wondfo

FDA registration
WONDFO USA CO., LTD.·2 products·🇺🇸 United States

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

FDA Pre-Market Approval
FDA Class 3 ·LIAISON® XL MUREX HBc IgM, LIAISON® XL MUREX Control HBc IgM

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

FDA Pre-Market Approval
FDA Class 3 ·VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBC IGM REAGENT PACK AND CALIBRATOR

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

FDA Pre-Market Approval
FDA Class 3 ·AXSYM CORE-M 2.0

RizyCure

Device
EU MDR · Eu Md Class 1 ·JC ORTHOHEAL PRIVATE LIMITED·On the market

RizyCure

Device
EU MDR · Eu Md Class 1 ·JC ORTHOHEAL PRIVATE LIMITED·On the market

FlexiOH

Device
EU MDR · Eu Md Class 1 ·JC ORTHOHEAL PRIVATE LIMITED·On the market

FlexiOH

Device
EU MDR · Eu Md Class 1 ·JC ORTHOHEAL PRIVATE LIMITED·On the market

FlexiOH

Device
EU MDR · Eu Md Class 1 ·JC ORTHOHEAL PRIVATE LIMITED·On the market

FlexiOH

Device
EU MDR · Eu Md Class 1 ·JC ORTHOHEAL PRIVATE LIMITED·On the market

FlexiOH

Device
EU MDR · Eu Md Class 1 ·JC ORTHOHEAL PRIVATE LIMITED·On the market