9 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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LIFEPAK® ECG Cables
FDA 510(k)
FDA Class 2
·Cardiovascular
MEDI
FDA UDI
MEDI MANUFACTURING, INC.·00636257130094·30-40 MV FOR MEN CLSC EW STD NAVY VII
ESR-Vacuum tubes
FDA UDI
STRECK, INC.·00844509000044·Safety-coated tri-sodium citrate blood collecti...
XTAG GASTROINTESTINAL PATHOGEN PANEL (GPP)/XTAG DATA ANALYSIS SOFTWARE FOR GPP (TDAS GPP)
FDA 510(k)
FDA Class 2
·Microbiology
RII INFRARED EAR THERMOMETER, MODELS THXXN SERIES
FDA 510(k)
FDA Class 2
·General Hospital
COLLEAGUE 3CX VOLUMETRIC INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE PTE.LTD.·Product code FRN·November 25, 2008
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Injury
·ANIMAS CORPORATION·Product code LZG·September 9, 2011
DUROM ACETABULAR COMPONENT 50/44 CODE J
FDA Adverse Event
Injury
·ZIMMER GMBH·Product code KWA·July 18, 2013
BioGX SARS-CoV-2 Reagents for BD MAX System-IVD PCR test intended for the qualitative detection of nucleic acid from the SARS-CoV-2 in nasopharyngeal specimens Catalog Number: 444213
FDA Enforcement
Class II
·Terminated·Becton Dickinson & Co.·April 21, 2021