8 results
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21ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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Access 25(OH) Vitamin D Total for Use on the UniCel Dxl Immuno. Syst. Access 25(OH) Vitamin D Total Calibrators for Use on the UniCel Dxl Immuno.
FDA 510(k)
FDA Class 2
·Clinical Chemistry
POWDER FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED)
FDA 510(k)
FDA Class 1
·General Hospital
MODIFICATION TO CARBON DIOXIDE-L3K ASSAY, CAT. NOS. 299-30, 299-17, 299-50, 299-80 AND 299-12
FDA 510(k)
FDA Class 2
·Clinical Chemistry
NUCLEUS 24 CONTOUR
FDA Adverse Event
Malfunction
·COCHLEAR LTD·Product code MCM·February 7, 2019
NOBLUS ULTRASOUND SCANNER
FDA Adverse Event
Malfunction
·Product code IYO·March 30, 2017
ROTATING MULTIPLE CLIP APPLIER
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, LLC.·Product code FZP·June 28, 2011
PELVICOL ACELLULAR COLLAGEN MATRIX
FDA Adverse Event
Injury
·TISSUE SCIENCE LABORATORIES·Product code FTL·May 22, 2013
PARADIGM REAL-TIME INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·October 5, 2014