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

FDA Pre-Market Approval

FDA Class 3 ·VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBC REAGENT PACK/CALIBRATOR

BYTECH

FDA 510(k)

FDA Class 1 ·General Hospital

Dental Components Sebastian Gałat

Importer

🇵🇱 Poland·1 Manufacturer

D3 Ultra Duet DFA Respiratory Virus

FDA registration

Ortho-Clinical Diagnostics, Inc.·5 products·🇺🇸 United States

Test, Alpha Fetoprotein L3 Subfraction (Afp-L3%), For Hepatocellular Carcinoma Risk Assessment

FDA classification

FDA Class 2 ·Test, Alpha Fetoprotein L3 Subfraction (Afp-L3%), For Hepatocellular Carcinoma Risk Assessment

MULTI-STIM TENS, AP-101081T

FDA 510(k)

FDA Class 2 ·Neurology

BIOSCOPE SD TENS, ARISTA SD PLUS, AP-102080T

FDA 510(k)

FDA Class 2 ·Neurology

AEMS V, EMS-1000, MODEL TS-140500 AND AEMS VI, EMS-1000 PLUS, MODEL TS-140600

FDA 510(k)

FDA Class 2 ·Physical Medicine

APEX MEDICAL LCD TENS-VII

FDA 510(k)

FDA Class 2 ·Neurology

ACU-STIM TENS, AP-101082T

FDA 510(k)

FDA Class 2 ·Neurology

BESTNEB PORTABLE AEROSOL THERAPY UNIT, AP-100100

FDA 510(k)

FDA Class 2 ·Anesthesiology

MODIFICATION TO:APEX MEDICAL IF-4100

FDA 510(k)

FDA Class 2 ·Neurology

COM-PATCH

FDA 510(k)

FDA Class 2 ·Neurology

MS104A, NEWMINI II (EMS-II), MODEL AP-101050T AND MEDTRIM (EMS-V), MODEL AP-102050T

FDA 510(k)

FDA Class 2 ·Physical Medicine

Geonic Nasal Aspirator, Geonic Nasal Cleaner

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

APEX MEDICAL DIGITAL TENS TS1211, TS1212

FDA 510(k)

FDA Class 2 ·Neurology

APEX MEDICAL DIGITAL EMS TS1311, TS1312

FDA 510(k)

FDA Class 2 ·Physical Medicine

MICRO II MICROCURRENT TENS

FDA 510(k)

FDA Class 2 ·Neurology

Disposable Pen Injector

Basic UDI-DI

EU MDR · Eu Md Class 2b ·Jiangsu Wan Hai Medical Instruments Co., Ltd·1 device

Pen Injector

Basic UDI-DI

EU MDR · Eu Md Class 2b ·Jiangsu Wan Hai Medical Instruments Co., Ltd·1 device