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

FDA Pre-Market Approval

FDA Class 3 ·ETI-MAK-2 PLUS, HBsAg Confirmatory Test Assays

Digital Thermometer, Models: AOJ-25A, AOJ-25B, AOJ-25C, AOJ-25D and AOJ-25E

FDA 510(k)

FDA Class 2 ·General Hospital

SUNGLASSES

FDA 510(k)

FDA Class 1 ·Ophthalmic

Forehead Thermometer, models AOJ-F101, AOJ-F102, AOJ-F103, AOJ-F104 AOJ-F105, AOJ-F106, AOJ-F107

FDA 510(k)

FDA Class 2 ·General Hospital

SunStim Peripheral Nerve Stimulator/Sunstim Plus Peripheral Nerve Stimulator

FDA 510(k)

FDA Class 2 ·Anesthesiology

Infrared Thermometer (AOJ-20A); Infrared Thermometer (AOJ-20Y)

FDA 510(k)

FDA Class 2 ·General Hospital

GaiaBone Bioabsorbable Bone Graft

FDA 510(k)

FDA Class 2 ·Orthopedic

Arm Blood Pressure Monitor, models AOJ-30A, AOJ-30B, AOJ-30C, AOJ-30D, AOJ-30E, AOJ-30F and AOJ-30G

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 ·ETI-MAK-2 PLUS and HBsAg Confirmatory Test Assays

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

FDA Pre-Market Approval

FDA Class 3 ·ETI MAK-2 PLUS and HBsAg Confirmatory Test assays

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

FDA Pre-Market Approval

FDA Class 3 ·ETI-MAK-2 PLUS and HBsAg Confirmatory Test Assays

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

FDA Pre-Market Approval

FDA Class 3 ·ETI MAK-2 PLUS and HBsAg Confirmatory Test assays

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

FDA Pre-Market Approval

FDA Class 3 ·ETI-MAK-2 PLUS and HBsAg Confirmatory Test assay

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

FDA Pre-Market Approval

FDA Class 3 ·ETI MAK-2 PLUS Assay and HBsAg Confirmatory Test

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

FDA Pre-Market Approval

FDA Class 3 ·ETI-MAK-2 PLUS and HBsAg Confirmatory Test assays

LUBRICARE MAINTENANCE SYSTEM

FDA UDI

Bien-Air Dental SA·J00716009150011·Lubricare is intended for lubricating and clean...

Lubricare Maintenance System

FDA UDI

Bien-Air Dental SA·J0071600915011·Device used to maintain optimum performance and...

LUBRICARE MAINTENANCE SYSTEM 2

FDA UDI

Bien-Air Dental SA·J00716011560011·Lubricare 2 is intended for lubricating and cle...

Primado

FDA UDI

NAKANISHI INC.·04560224991080·

Wrist Blood Pressure Monitor, models AOJ-35A, AOJ-35B, AOJ-35C, AOJ-35D, AOJ-35E

FDA 510(k)

FDA Class 2 ·Cardiovascular