52 results
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25ms
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Sources: EU EUDAMED, US FDA
HTR POLYMER, HTR-MX
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
NUDA (CURRENTLY CALLED ULTRA SENSITIVE)
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
KEELER KONAN SPECULAR MICROSCOPE SP3300
FDA 510(k)
FDA Class 2
·Ophthalmic
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·July 9, 2015
QUATTRODE LEAD
FDA Adverse Event
Injury
·ADVANCED NEUROMODULATION SYSTEMS·Product code LGW·October 28, 2010
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·July 1, 2014
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
Glycated Hemoglobin A1c (HbA1c) Test Kit (Fluorescence Immunochromatographic Assay)
Basic UDI-DI
EU IVDD
·
Eu Ivd General
·SHENZHEN REETOO BIOTECHNOLOGY CO., LTD·1 device
D-Dimer Test Kit (Fluorescence Immunochromatographic Assay)
Basic UDI-DI
EU IVDD
·
Eu Ivd General
·SHENZHEN REETOO BIOTECHNOLOGY CO., LTD·1 device