19 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Paragon Adult Maxi PMP Oxygenator (Model: XCMOP405PMP)
FDA 510(k)
FDA Class 2
·Cardiovascular
ILED 3 MOBILE (I300M), TRULIGHT 5500 MOBILE (T500M), TRULIGHT 5300 MOBILE (T300M)
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
SPIRALE DRUG DELIVERY SYSTEM
FDA 510(k)
FDA Class 2
·Anesthesiology
CONTOUR® PLUS
FDA Adverse Event
Malfunction
·ASCENSIA DIABETES CARE US INC.·Product code NBW·September 10, 2025
CONTOUR® XT
FDA Adverse Event
Malfunction
·ASCENSIA DIABETES CARE US INC.·Product code NBW·April 23, 2026
HARMONIC SCALPEL SHARP HOOK
FDA Adverse Event
Malfunction
·ETHICON ENDO SURGERY, INC. (CINCINNATI)·Product code LFL·October 9, 2008
SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE
FDA Adverse Event
Injury
·BAXTER HEALTHCARE·Product code KDJ·June 26, 2013
9600
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·July 19, 2011
CONTOUR® PLUS
FDA Adverse Event
Malfunction
·ASCENSIA DIABETES CARE US INC.·Product code NBW·May 1, 2026
CONTOUR® XT
FDA Adverse Event
Malfunction
·ASCENSIA DIABETES CARE US INC.·Product code NBW·May 15, 2025
ACCU-CHEK SPIRIT
FDA Adverse Event
Injury
·ROCHE INSULIN DELIVERY SYSTEMS INC.·Product code LZG·May 10, 2010
CONTOUR® PLUS
FDA Adverse Event
Malfunction
·ASCENSIA DIABETES CARE US INC.·Product code NBW·December 31, 2025
CONTOUR® NEXT
FDA Adverse Event
Malfunction
·ASCENSIA DIABETES CARE US INC.·Product code NBW·May 12, 2026
CONTOUR® PLUS
FDA Adverse Event
Malfunction
·ASCENSIA DIABETES CARE US INC.·Product code NBW·September 11, 2025
CONTOUR® PLUS
FDA Adverse Event
Malfunction
·ASCENSIA DIABETES CARE US INC.·Product code NBW·October 8, 2025
BIO-COMP SWIVELOCK C, CLD 5.5X19.1MM
FDA Adverse Event
Injury
·ARTHREX, INC.·Product code MAI·April 22, 2020
CONTOUR® PLUS
FDA Adverse Event
Malfunction
·ASCENSIA DIABETES CARE US INC.·Product code NBW·December 1, 2023
CONTOUR® PLUS
FDA Adverse Event
Injury
·ASCENSIA DIABETES CARE US INC.·Product code NBW·May 15, 2025
CONTOUR® PLUS
FDA Adverse Event
Malfunction
·ASCENSIA DIABETES CARE US INC.·Product code NBW·November 4, 2025