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

FDA Pre-Market Approval
FDA Class 3 ·Elecsys Anti-HBe, PreciControl Anti-HBe

QEF Sunglasses

FDA registration
QEF DESIGN CORPORATION·1 product·🇹🇼 Taiwan

Magnifying Spectacles

FDA registration
QEF DESIGN CORPORATION·1 product·🇹🇼 Taiwan

Dimension Vista IGE Flex

FDA registration
Siemens Healthcare Diagnostics Products GmbH·3 products·🇩🇪 Germany

CORONET Forceps

FDA registration
NETWORK MEDICAL PRODUCTS, LTD.·1 product·🇬🇧 United Kingdom

Cellulose Point

FDA registration
NETWORK MEDICAL PRODUCTS, LTD.·1 product·🇬🇧 United Kingdom

PVA Point

FDA registration
NETWORK MEDICAL PRODUCTS, LTD.·1 product·🇬🇧 United Kingdom

Endoglide Ultrathin

FDA registration
NETWORK MEDICAL PRODUCTS, LTD.·1 product·🇬🇧 United Kingdom

Donor Trephine Punch

FDA registration
NETWORK MEDICAL PRODUCTS, LTD.·1 product·🇬🇧 United Kingdom

Aspiration Cannulas

FDA registration
NETWORK MEDICAL PRODUCTS, LTD.·1 product·🇬🇧 United Kingdom

Guarded Trephine (400 Micron)

FDA registration
NETWORK MEDICAL PRODUCTS, LTD.·1 product·🇬🇧 United Kingdom

Single Use Suction Tubes

FDA registration
NETWORK MEDICAL PRODUCTS, LTD.·1 product·🇬🇧 United Kingdom

Gutta Percha Points

FDA registration
SHANGHAI XING YU MEDICAL EQUIPMENT CO., LTD.·1 product·🇨🇳 China

Absorbent Paper Points

FDA registration
SHANGHAI XING YU MEDICAL EQUIPMENT CO., LTD.·1 product·🇨🇳 China

Dental Files

FDA registration
SHANGHAI XING YU MEDICAL EQUIPMENT CO., LTD.·1 product·🇨🇳 China

AGE Automatic Wrist Blood Pressure Monitor

FDA 510(k)
FDA Class 2 ·Cardiovascular

ANTI-WRINKLE (AGING) LIGHT, MODEL AAL

FDA 510(k)
FDA Class 2 ·General, Plastic Surgery

NAVIAID BGE DEVICE, MODEL 21-001

FDA 510(k)
FDA Class 2 ·Gastroenterology, Urology

AGE Automatic Wrist Blood Pressure Monitor

FDA 510(k)
FDA Class 2 ·Cardiovascular

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

FDA Pre-Market Approval
FDA Class 3 ·VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBE REAGENT PACK/ANTI-HBE CALIBRATOR/ANTI HBE CONTROLS