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