13 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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3 Series NeoLux
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
ALM RETRACTOR
FDA UDI
SONTEC INSTRUMENTS, INC.·00192896077270·ALM RETRACTOR
HEARTSTRING III PROXIMAL SEAL SYSTEM
FDA 510(k)
FDA Class 2
·Cardiovascular
SELITHERM, MODEL C100
FDA 510(k)
FDA Class 2
·Physical Medicine
CADD SOLIS VIP PUMP
FDA Adverse Event
Malfunction
·SMITHS MEDICAL ASD, INC.·Product code FRN·October 21, 2019
CADD SOLIS VIP PUMP
FDA Adverse Event
Malfunction
·SMITHS MEDICAL ASD, INC.·Product code FRN·October 21, 2019
CADD SOLIS VIP PUMP
FDA Adverse Event
Malfunction
·SMITHS MEDICAL ASD, INC.·Product code FRN·October 21, 2019
CADD SOLIS VIP PUMP
FDA Adverse Event
Malfunction
·SMITHS MEDICAL ASD, INC.·Product code FRN·October 21, 2019
IAB : 8 FR - 40 CC FOS
FDA Adverse Event
Malfunction
·ARROW INTL., INC.·Product code DSP·November 7, 2008
PROLIFT MESH KIT
FDA Adverse Event
Other
·UNK·Product code FTL·August 28, 2011
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·July 16, 2013
VASO VIEW HEMOPRO
FDA Adverse Event
Malfunction
·MAQUET CARDIOVASCULAR LLC·Product code GEI·April 15, 2019
BioGX SARS-CoV-2 Reagents for BD MAX System-IVD PCR test intended for the qualitative detection of nucleic acid from the SARS-CoV-2 in nasopharyngeal specimens Catalog Number: 444213
FDA Enforcement
Class II
·Terminated·Becton Dickinson & Co.·April 21, 2021