11 results
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25ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Agilon Strip
FDA 510(k)
FDA Class 2
·Orthopedic
HEMO-CATH 10F, HEMO-CATH 12.5F
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
FORA PNC100 DIGITAL PREGANCY TEST, TD-5301 PREGANCY TEST
FDA 510(k)
FDA Class 2
·Clinical Chemistry
CONTOUR PLUS ELITE
FDA Adverse Event
Malfunction
·ASCENSIA DIABETES CARE US INC.·Product code NBW·August 22, 2024
CONTOUR PLUS ELITE
FDA Adverse Event
Malfunction
·ASCENSIA DIABETES CARE US INC.·Product code NBW·July 1, 2023
NONE
FDA Adverse Event
Malfunction
·PHILIPS MEDICAL SYSTEMS·Product code MKJ·October 8, 2008
LAUREATE WORLD PHACO SYSTEM
FDA Adverse Event
Malfunction
·ALCON - IRVINE TECHNOLOGY CTR·Product code HQC·July 13, 2011
WIRECUTTER LRG W/CANTILEVER L220
FDA Adverse Event
Malfunction
·SYNTHES GMBH·Product code FZX·June 27, 2013
Illumina MiSeqDx Cystic Fibrosis Clinical Sequencing Assay in vitro diagnostic system for use on the Illumina MiSeqDx Platform.
FDA Enforcement
Class III
·Terminated·Illumina Inc·December 31, 2014
CONTOUR® NEXT
FDA Adverse Event
Malfunction
·ASCENSIA DIABETES CARE US INC.·Product code NBW·November 10, 2023
CONTOUR® NEXT
FDA Adverse Event
Malfunction
·ASCENSIA DIABETES CARE US INC.·Product code NBW·October 23, 2023