54 results
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18ms
·
Sources: EU EUDAMED, US FDA
RELAXU-1
FDA 510(k)
FDA Class 1
·Physical Medicine
SpiritMB
FDA UDI
ORMCO CORPORATION·00889989007398·ID U - Twin - Lower-Left Cuspid - Purple
ZIMMER A.T.S. 3000 AUTOMATIC TOURNIQUET SYSTEM
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
DANNIK® Laparoscopic Single-Use Poly Specimen Retrieval System
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
FLOGARD
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·February 8, 2013
ILLUMENA-SYR-W/HF-150ML BX50
FDA Adverse Event
Malfunction
·COVIDIEN·Product code DXT·December 14, 2010
PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)
FDA Adverse Event
Malfunction
·INVACARE FLORIDA OPERATIONS·Product code CAW·July 22, 2014
Optical Access System; 5mm x 100mm and 12mm x 100mm; Model #: CTR03 and CTR73. Indicated for use to establish a port of entry fro endoscopic instruments in patients requiring minimally invasive surgical procedures including thoracic, gynecologic laparoscopy and other abdominal procedures.
FDA Enforcement
Class II
·Terminated·Stryker Sustainability Solutions·July 1, 2015
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