8 results
·
21ms
·
Sources: EU EUDAMED, US FDA
KODAK AMERLITE MAB FT3 ASSAY
FDA 510(k)
FDA Class 2
·Clinical Chemistry
DFA RESPIRATORY VIRUS SCREENING & ID KIT
FDA 510(k)
FDA Class 1
·Microbiology
White Nitrile Powder Free Patient Examination Glove, Non Sterile
FDA 510(k)
FDA Class 1
·General Hospital
FEMORAL IMPACTOR EXTRACTOR
FDA Adverse Event
Malfunction
·STRYKER ORTHOPAEDICS MAHWAH·Product code HWA·December 28, 2012
LEAD MODEL 302
FDA Adverse Event
Malfunction
·CYBERONICS, INC.·Product code LYJ·November 12, 2010
SPECTRUM INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HLTHCARE CORP·Product code FRN·January 14, 2014
ACCESS HIGH SENSITIVITY TROPONIN I
FDA Adverse Event
Injury
·BECKMAN COULTER·Product code MMI·September 6, 2021
Access hsTnI High Sensitivity Troponin I, REF B52699 Access Immunoassay System REAGENT PACK
FDA Enforcement
Class II
·Ongoing·Beckman Coulter Inc.·October 13, 2021