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

FDA Pre-Market Approval

FDA Class 3 ·VITROS IMMUNODIAGNOSTIC PRODUCTS HBSAG REAGENT PACK, CALIBRATOR, CONFIRMATORY KIT

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

FDA Pre-Market Approval

FDA Class 3 ·AXSYM CORE 2.0 (LN 8B88)

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

FDA Pre-Market Approval

FDA Class 3 ·VITROS ANTI-HBE ASSAY

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval

FDA Class 3 ·VISTAKON SENOFILCON A BRAND CONTACT LENSES

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval

FDA Class 3 ·VISTAKON (SENOFILCON A) CONTACT LENSES

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

FDA Pre-Market Approval

FDA Class 3 ·VITROS Immunodiagnostic Products Anti-HBs Quantitative Reagent Pack and Calibrator

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

FDA Pre-Market Approval

FDA Class 3 ·Elecsys HBeAg

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

FDA Pre-Market Approval

FDA Class 3 ·Elecsys HBcAg

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval

FDA Class 3 ·VISTAKON (senofilcon A) Brand Contact Lenses

Agent, Bulking, Injectable For Gastro-Urology Use

FDA Pre-Market Approval

FDA Class 3 ·Deflux Injectable Gel

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval

FDA Class 3 ·PERMALENS EXTENDED WEAR CONTACT LENS

Over-The-Counter Automated External Defibrillator

FDA classification

FDA Class 3 ·Over-The-Counter Automated External Defibrillator

XPA-12B-4XL

FDA registration

U.S. ORTHOTICS, INC.·1 product·🇺🇸 United States

PHICOGIS EUROPE SARL

Importer

🇫🇷 France·4 Manufacturers

Arthrone Oy

Importer

🇫🇮 Finland·7 Manufacturers

Arseus Medical Group BV

Importer

🇳🇱 Netherlands·13 Manufacturers

International Associates Auditing & Certification Limited

Authorized representative

🇮🇪 Ireland·46 Manufacturers·161 Devices

Med Consulting Srl

Importer

🇮🇹 Italy·12 Manufacturers

Urology

FDA registration

Sklar Corporation - Warehouse·23 products·🇺🇸 United States

Urology

FDA registration

Sklar Corporation·23 products·🇺🇸 United States