54 results
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24ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Merit 20 mL Syringe
FDA 510(k)
FDA Class 2
·General Hospital
MODIFICATION TO: IQ GUIDE WIRE, MODELS 38950-XX. 38951-XX
FDA 510(k)
FDA Class 2
·Cardiovascular
HINSON & HALE MEDICAL TECHNOLOGIES INFUSED (R) POLYESTER WRAPPERS
FDA 510(k)
FDA Class 2
·General Hospital
BINAXNOW COVID-19 AG CARD
FDA Adverse Event
Malfunction
·ABBOTT DIAGNOSTICS SCARBOROUGH, INC.·Product code QKP·October 7, 2021
CARELINK
FDA Adverse Event
Malfunction
·MEDTRONIC, INC.·Product code DXY·June 8, 2013
AUTOCAT2
FDA Adverse Event
Malfunction
·ARROW INTERNATIONAL, INC.·Product code DSP·July 3, 2011
AXSYM AUSAB
FDA Adverse Event
Malfunction
·ABBOTT LABORATORIES·Product code LOM·September 10, 2008
SENRI
FDA Adverse Event
Injury
·KANEKA CORPORATION·Product code LIT·April 2, 2021
SENRI
FDA Adverse Event
Injury
·KANEKA CORPORATION·Product code LIT·July 9, 2019
Certain EP Healing Abutment 4.1mm(D) x 5mm(P) x 2mm(H) Item: ITHA52 Dental implants
FDA Enforcement
Class II
·Terminated·Biomet 3i, LLC·August 24, 2016
SENRI
FDA Adverse Event
Injury
·KANEKA CORPORATION·Product code LIT·July 11, 2024
SENRI
FDA Adverse Event
Injury
·KANEKA CORPORATION·Product code LIT·February 20, 2020
SENRI
FDA Adverse Event
Injury
·KANEKA·Product code LIT·March 12, 2019
SENRI
FDA Adverse Event
Injury
·KANEKA CORPORATION·Product code LIT·May 6, 2025
SENRI
FDA Adverse Event
Injury
·KANEKA CORPORATION·Product code LIT·December 24, 2025
DIVA
FDA Adverse Event
Injury
·KANEKA CORPORATION·Product code LIT·July 7, 2020
DIVA
FDA Adverse Event
Injury
·KANEKA CORPORATION·Product code LIT·July 7, 2020
SHIRANUI EX
FDA Adverse Event
Injury
·KANEKA CORPORATION·Product code LIT·August 12, 2020
18 SHIDEN HP
FDA Adverse Event
Injury
·KANEKA CORPORATION·Product code LIT·August 19, 2025
SENRI
FDA Adverse Event
Injury
·KANEKA CORPORATION·Product code LIT·August 12, 2025