Portex

FDA registration

ICU Medical Healthcare Manufacturing S.A. de C.V.·1 product·🇲🇽 Mexico

Portex

FDA registration

ICU Medical, Inc.·1 product·🇺🇸 United States

INCENTIVE SPIROMETER

FDA 510(k)

FDA Class 2 ·Anesthesiology

Spirometer, Therapeutic (Incentive)

FDA classification

FDA Class 2 ·Spirometer, Therapeutic (Incentive)

Diazyme Direct HbA1c Assay (Enzymatic, On-Board Lysis)

FDA registration

Diazyme Laboratories, Inc.·3 products·🇺🇸 United States

AESCULAP AG

FDA registration

AESCULAP AG·1 product·🇩🇪 Germany

Synergy Plus

FDA registration

THE PROMETHEUS GROUP·1 product·🇺🇸 United States

AESCULAP PEEK VERTEBRAL BODY REPLACEMENT SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

Diazyme Direct HbA1c Assay (Enzymatic, On-Board Lysis), Diazyme Direct HbA1c Assay Calibrator Set, Diazyme Direct HbA1c Assay Control Set

FDA 510(k)

FDA Class 2 ·Hematology

AVCOO, Tens & Ems Device, model TX6061

FDA registration

YUCHENG TECHNOLOGY (HK) LIMITED·2 products·🇭🇰 Hong Kong

AVCOO, Tens & Ems Device, model AS8019

FDA registration

YUCHENG TECHNOLOGY (HK) LIMITED·2 products·🇭🇰 Hong Kong

AVCOO, TENS & PMS, model SM9126

FDA registration

YUCHENG TECHNOLOGY (HK) LIMITED·2 products·🇭🇰 Hong Kong

AVCOO, TENS and EMS Stimulation (OTC), model TU1130

FDA registration

YUCHENG TECHNOLOGY (HK) LIMITED·2 products·🇭🇰 Hong Kong

AVCOO, OTC TENS & EMS Unit, model TA2224C

FDA registration

YUCHENG TECHNOLOGY (HK) LIMITED·2 products·🇭🇰 Hong Kong

Sunglasses (non-prescription including photosensitive)

FDA registration

OKIA VIETNAM HOLDINGS COMPANY LIMITED·1 product·🇭🇰 Hong Kong

SPECTACLE, MAGNIFYING

FDA registration

OKIA VIETNAM HOLDINGS COMPANY LIMITED·1 product·🇭🇰 Hong Kong

Shield, eye, ophthalmic (including sunlamp protective eyewear and post-mydriatic eyewear)

FDA registration

OKIA VIETNAM HOLDINGS COMPANY LIMITED·1 product·🇭🇰 Hong Kong

Frame, spectacle

FDA registration

OKIA VIETNAM HOLDINGS COMPANY LIMITED·1 product·🇭🇰 Hong Kong

Assay, Glycosylated Hemoglobin

FDA classification

FDA Class 2 ·Assay, Glycosylated Hemoglobin

Spinal Vertebral Body Replacement Device

FDA classification

FDA Class 2 ·Spinal Vertebral Body Replacement Device