55 results
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26ms
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Sources: EU EUDAMED, US FDA
ANTI-GBM ANTIBODIES QUANTITATIVE KIT
FDA 510(k)
FDA Class 2
·Immunology
RP UCLA Abutment Waxing Sleeve, Hexed
FDA UDI
STERNGOLD DENTAL LLC·00841549110580·The UCLA-Type Abutment is attached directly to ...
IV SET AN115 23G 1IN BP
FDA Adverse Event
Malfunction
·BECTON DICKINSON·Product code FOZ·August 2, 2019
MICRO-VENT ENDOSSEOUS IMPLANT ABUTMENTS
FDA 510(k)
FDA Class 2
·Dental
CATHETER CARE TRAY
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
SLEEK
FDA Adverse Event
Injury
·CLEARSTREAM TECHNOLOGIES, LTD.·Product code LIT·May 26, 2014
ANIMAS INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·ANIMAS CORP.·Product code LZG·November 15, 2010
VISI-PRO BALLOON EXPANDABLE BILIARY STENT SYSTEM
FDA Adverse Event
Injury
·EV3 INC.·Product code FGE·January 9, 2013
N-terminal pro-B-type Natriuretic Peptide &Cardiac Troponin I Combo Test Kit (Fluorescence Immunochromatographic Assay)
Basic UDI-DI
EU IVDD
·
Eu Ivd General
·SHENZHEN REETOO BIOTECHNOLOGY CO., LTD·1 device
Beta 2 microglobulin (β2-MG) Test Kit (Fluorescence Immunochromatographic Assay)
Basic UDI-DI
EU IVDD
·
Eu Ivd General
·SHENZHEN REETOO BIOTECHNOLOGY CO., LTD·1 device
Serum Amyloid A (SAA) & Full C-reactive protein (CRP) Combo Test Kit (Fluorescence Immunochromatographic Assay)
Basic UDI-DI
EU IVDD
·
Eu Ivd General
·SHENZHEN REETOO BIOTECHNOLOGY CO., LTD·1 device
Procalcitonin (PCT) & Full C-reactive protein (CRP) Combo Test Kit (Fluorescence Immunochromatographic Assay)
Basic UDI-DI
EU IVDD
·
Eu Ivd General
·SHENZHEN REETOO BIOTECHNOLOGY CO., LTD·1 device
Thyroid Stimulating Hormone(TSH) Test Kit (Fluorescence Immunochromatographic Assay)
Basic UDI-DI
EU IVDD
·
Eu Ivd General
·SHENZHEN REETOO BIOTECHNOLOGY CO., LTD·1 device
Total Thyroxine(T4) Test Kit (Fluorescence Immunochromatographic Assay)
Basic UDI-DI
EU IVDD
·
Eu Ivd General
·SHENZHEN REETOO BIOTECHNOLOGY CO., LTD·1 device
Total Triiodothyronine(T3) Test Kit (Fluorescence Immunochromatographic Assay)
Basic UDI-DI
EU IVDD
·
Eu Ivd General
·SHENZHEN REETOO BIOTECHNOLOGY CO., LTD·1 device
Myoglobin (Myo) Test Kit (Fluorescence Immunochromatographic Assay)
Basic UDI-DI
EU IVDD
·
Eu Ivd General
·SHENZHEN REETOO BIOTECHNOLOGY CO., LTD·1 device
Cardiac Troponin I (cTnI) Test Kit (Fluorescence Immunochromatographic Assay)
Basic UDI-DI
EU IVDD
·
Eu Ivd General
·SHENZHEN REETOO BIOTECHNOLOGY CO., LTD·1 device
Full C-reactive protein (CRP) Test Kit (Fluorescence Immunochromatographic Assay)
Basic UDI-DI
EU IVDD
·
Eu Ivd General
·SHENZHEN REETOO BIOTECHNOLOGY CO., LTD·1 device
Creatine kinase Isoenzyme MB(CK-MB) Test Kit (Fluorescence Immunochromatographic Assay)
Basic UDI-DI
EU IVDD
·
Eu Ivd General
·SHENZHEN REETOO BIOTECHNOLOGY CO., LTD·1 device
Serum Amyloid A (SAA) Test Kit (Fluorescence Immunochromatographic Assay)
Basic UDI-DI
EU IVDD
·
Eu Ivd General
·SHENZHEN REETOO BIOTECHNOLOGY CO., LTD·1 device