11 results
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38ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Disposable Insulin Pen Needle
FDA 510(k)
FDA Class 2
·General Hospital
BSM-6300A
FDA Adverse Event
Other
·NIHON KOHDEN TOMIOKA CORPORATION·Product code MHX·May 12, 2016
BSM-6300A
FDA Adverse Event
Malfunction
·NIHON KOHDEN CORPORATION·Product code MHX·June 9, 2016
SL-PLUS LATERALIZED STEM
FDA 510(k)
FDA Class 2
·Orthopedic
TRANSCORP ACIF SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
ILAB POLARIS MULTI-MODALITY GUIDANCE SYSTEM
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code DQK·March 3, 2025
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·August 13, 2025
ILAB? POLARIS MULTI-MODALITY GUIDANCE SYSTEM
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code DQK·May 14, 2026
SENSAR
FDA Adverse Event
Injury
·ABBOTT MEDICAL OPTICS·Product code HQL·November 3, 2014
LIGASURE V SEALER/DIVIDER
FDA Adverse Event
Injury
·COVIDIEN LP (VALLEYLAB)·Product code GEI·August 16, 2011
URETEX SUPPORT PP KIT X1
FDA Adverse Event
Death
·SOFRADIM PRODUCTION·Product code OTN·July 3, 2013