GR100F URINE FLOWMETER

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

ENDOFLIP

FDA 510(k)

FDA Class 2 ·Orthopedic

ACPlus Respiratory Assessment

FDA UDI

ACCELERATED CARE PLUS CORP·00858703006344·Software and sensor to provide assessment of re...

ONE STEP Malaria (P.F) Rapid Test (Colloidal Gold)

Device

EU IVDD · Eu Ivd General ·Shenzhen Superbio Technology Co.,Ltd.·On the market

ONE STEP Malaria (P.F) Rapid Test (Colloidal Gold)

Device

EU IVDD · Eu Ivd General ·Shenzhen Superbio Technology Co.,Ltd.·On the market

RapidFor™ Malaria P.f. / P.v. Rapid Test Kit

Device

EU IVDD · Eu Ivd General ·Vitrosens Biyoteknoloji Anonim Şirketi·On the market

RapidFor™ Malaria P.f. (pLDH) Rapid Test Kit

Device

EU IVDD · Eu Ivd General ·Vitrosens Biyoteknoloji Anonim Şirketi·On the market

RapidFor™ Malaria P.f. / Pan Rapid Test Kit

Device

EU IVDD · Eu Ivd General ·Vitrosens Biyoteknoloji Anonim Şirketi·On the market

RapidFor™ Malaria P.f. (HRP2) Rapid Test Kit

Device

EU IVDD · Eu Ivd General ·Vitrosens Biyoteknoloji Anonim Şirketi·On the market

Compact

FDA UDI

VITALOGRAPH (IRELAND) LIMITED·05099169414846·GENERIC CLINICAL TRIAL CASE - MIP MEP COMPACT(1)

Malaria Ag P.f (HRP-Ⅱ) Assay Reagent Kit (CMIA)

Device

EU IVDD · Eu Ivd General ·Hangzhou Realy Tech Co.,Ltd.·On the market

Malaria Ag P.f (HRP-Ⅱ) Assay Reagent Kit (CMIA)

Device

EU IVDD · Eu Ivd General ·Hangzhou Cybereagen Biotech Co., Ltd.·On the market

RapidFor™ Malaria P.f. / P.v. Rapid Test Kit (FIA)

Device

EU IVDD · Eu Ivd General ·Vitrosens Biyoteknoloji Anonim Şirketi·On the market

RapidFor™ Malaria P.f. / Pan Rapid Test Kit (FIA)

Device

EU IVDD · Eu Ivd General ·Vitrosens Biyoteknoloji Anonim Şirketi·On the market

CapMedic®

FDA UDI

Cognita Labs, LLC·00860003953709·CapMedic is an interactive smart inhaler add-on...

Immunohistochemistry Assay, Antibody, Epidermal Growth Factor Receptor

FDA Pre-Market Approval

FDA Class 3 ·DAKOCYTOMATION EGFR PHARMDX

Laser, Ophthalmic

FDA Pre-Market Approval

FDA Class 2 ·SUNRISE TECHNOLOGIES HYPERION(TM) HOLMIUM LASER SYSTEM FOR LASER THERMAL KERATOPLASTY (LTK)

Immunohistochemistry Assay, Antibody, Epidermal Growth Factor Receptor

FDA Pre-Market Approval

FDA Class 3 ·EGFR pharmDx

Immunohistochemistry Assay, Antibody, Epidermal Growth Factor Receptor

FDA Pre-Market Approval

FDA Class 3 ·EGFR pharmDx

Immunohistochemistry Assay, Antibody, Epidermal Growth Factor Receptor

FDA Pre-Market Approval

FDA Class 3 ·EGFR pharmDx