Meijer

FDA UDI

MEIJER, INC.·00713733189989·Infinity II Power Toothbrush with 2 EF RBH

EVIS EXERA III BRONCHOVIDEOSCOPE

FDA UDI

OLYMPUS MEDICAL SYSTEMS CORP.·04953170335174·BF-H190 EEIII HIGH DEF DIAGNOS IC BRONCH

560P

FDA UDI

Smith & Nephew, Inc.·03596010609786·SVCE REPL CAM CONTROL UNT HIGH DEF 560P

RETINA TOMOGRAPH AND FLOWMETER

FDA 510(k)

FDA Class 2 ·Ophthalmic

RETINA FLOWMETER

FDA 510(k)

FDA Class 2 ·Ophthalmic

RETINA ANGIOGRAPH

FDA 510(k)

FDA Class 2 ·Ophthalmic

BIOFIRE FILMARRAY Pneumonia Panel

FDA registration

BioFire Diagnostics, LLC·2 products·🇺🇸 United States

AEF POSIDYNE I.V. FILTER/AIR ELIMINATOR

FDA 510(k)

FDA Class 2 ·General Hospital

Immunohistochemistry Assay, Antibody, Met

FDA Pre-Market Approval

FDA Class 3 ·VENTANA MET (SP44) RxDx Assay

Immunohistochemistry Assay, Antibody, Met

FDA Pre-Market Approval

FDA Class 3 ·VENTANA MET (SP44) RxDx Assay

Immunohistochemistry Assay, Antibody, Met

FDA Pre-Market Approval

FDA Class 3 ·VENTANA MET (SP44) RxDx Assay

GELBISH VASCULAR DILATOR

FDA 510(k)

FDA Class 2 ·Cardiovascular

Aditus

Device

EU MDD · Eu Md Class 3 ·Bonegraft Biomaterials Co.·On the market·32 countries

PHOTOTHERAPY EQUIPMENT

Device

EU MDD · Eu Md Class 2a ·Zero-Plus International Limited·On the market·1 country

Nutrient Agar (8 ml)

Device

EU IVDR · Eu Ivd Class A ·Biolab Zrt·On the market·1 country

Nutrient Agar (6 ml)

Device

EU IVDR · Eu Ivd Class A ·Biolab Zrt·On the market·1 country

Nutrient Agar (4 ml)

Device

EU IVDR · Eu Ivd Class A ·Biolab Zrt·On the market·1 country

Dental Zirconia Block

Device

EU MDD · Eu Md Class 2a ·Shenzhen Yurucheng Dental Materials Co., Ltd.·On the market·2 countries

JADE PTA

Device

EU MDD · Eu Md Class 2a ·OrbusNeich Medical (Shenzhen) Co.,Ltd·On the market·1 country

Disposable Subdermal Needle Electrode, twisted

Device

EU MDD · Eu Md Class 2a ·Technomed Europe·On the market·32 countries