5,908 results
·
41ms
·
Sources: EU EUDAMED, US FDA
ASTRA SYSTEMS MULTIPLE CHEMISTRY MODULE
FDA 510(k)
FDA Class 1
·Clinical Chemistry
HDL-ADVANCE ASSAY, CAT. NO. 278-20, 278-50A, 278-50B
FDA 510(k)
FDA Class 1
·Clinical Chemistry
HDL CHOLESTEROL, PRODUCT NO'S 124-01, CH102-01
FDA 510(k)
FDA Class 1
·Clinical Chemistry
WAKO HDL CHOLESTEROL TEST
FDA 510(k)
FDA Class 1
·Clinical Chemistry
GERMAINE LABORATORIES, INC.
FDA registration
GERMAINE LABORATORIES, INC.·6 products·🇺🇸 United States
LipidPlus Professional Lipid Profile and Glucose Measuring System
FDA registration
JANT PHARMACAL CORP.·6 products·🇺🇸 United States
LipidPro
FDA registration
OSANG Healthcare CO., LTD.·6 products·🇰🇷 South Korea
LipidPlus Cholesterol & Glucose Measuring System
FDA registration
JANT PHARMACAL CORP.·6 products·🇺🇸 United States
Vantera Clinical Analyzer
FDA UDI
Labcorp of America·B3959900300·Clinical Analyzer
NMR Reference Standard
FDA UDI
Labcorp of America·B3959930030·NMR Reference Standard used for the Vantera Cli...
NMR WASH Solution
FDA UDI
Labcorp of America·B3959910030·WASH Solution used for the Vantera Clinical Ana...
NMR Diluent 1
FDA UDI
Labcorp of America·B3959920030·Sample Diluent 1 used for the Vantera Clinical ...
Implantable Cardioverter Defibrillator (Non-Crt)
FDA Pre-Market Approval
FDA Class 3
·EVERA MRI DF-1/ DF-1 ICD/MRI ICD/ EVERA XT DR ICD/ VR ICD; PROTECTA XT ICD; SECURA ICD; VIRTUOSO II DR/VR ICD; VISIA AF
Surgical Instrument
Basic UDI-DI
EU MDD
·
Eu Md Class 2a
·SWEDEN & MARTINA S.P.A.·1 device
ASAHI Hyperion Coronary Guide Catheter
Basic UDI-DI
EU MDD
·
Eu Md Class 3
·ASAHI INTECC CO., LTD.·1 device
Asqelio Pluris Preloaded IOL Delivery System
Basic UDI-DI
EU MDD
·
Eu Md Class 2b
·AST VisionCare Inc.·1 device
Asqelio Toric Preloaded IOL Delivery System
Basic UDI-DI
EU MDD
·
Eu Md Class 2b
·AST VisionCare Inc.·1 device
Prosthetic Component
Basic UDI-DI
EU MDD
·
Eu Md Class 2a
·SWEDEN & MARTINA S.P.A.·1 device
0.40*25
Basic UDI-DI
EU MDR
·
Eu Md Class 2a
·Gushi County Zhenzheng Medical Device Co.,Ltd·2 devices
Accufuser Omnibus
Basic UDI-DI
EU MDD
·
Eu Md Class 2b
·Woo Young Medical Co., Ltd.·1 device