14 results
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24ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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S1
FDA 510(k)
FDA Class 2
·Dental
BD BBL™ Sensi-Disc™ Ofloxacin 5 µg
FDA UDI
BECTON, DICKINSON AND COMPANY·30382902316726·BD BBL™ Sensi-Disc™ Ofloxacin 5 µg
MICROCYN SCAR MANAGEMENT HYDROGEL
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
SPINAL CONCEPTS, INC. INFIX SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
CONTOUR® PLUS BLUE
FDA Adverse Event
Malfunction
·ASCENSIA DIABETES CARE US INC.·Product code NBW·March 13, 2025
BD BBL Sensi Disc Ofloxacin- 5 ug, used for semi-quantitative in vitro susceptibility testing. Catalog Number 231672¿
FDA Enforcement
Class II
·Ongoing·Becton Dickinson & Co.·February 14, 2024
GRANUFLO
FDA Adverse Event
Death
·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code KPO·November 4, 2014
MINICAP
FDA Adverse Event
Injury
·BAXTER HEALTHCARE - CLEVELAND·Product code KDI·September 1, 2011
PELVILACE TO BIOURETHRAL SUPPORT SYSTEM
FDA Adverse Event
Injury
·TISSUE SCIENCE LABORATORIES·Product code FTL·July 12, 2013
CONTOUR® PLUS BLUE
FDA Adverse Event
Malfunction
·ASCENSIA DIABETES CARE US INC.·Product code NBW·February 11, 2025
CONTOUR® CARE
FDA Adverse Event
Malfunction
·ASCENSIA DIABETES CARE US INC.·Product code NBW·June 13, 2025
BD BBL Sensi Disc Ofloxacin- 5 ug, used for semi-quantitative in vitro susceptibility testing. Catalog Number 231672
FDA Recall
Open, Classified
·Becton Dickinson & Co.·Product code JTN·January 8, 2024
KIDS OXYGENATOR D101
FDA Adverse Event
Malfunction
·SORIN GROUP ITALIA SRL·Product code DTZ·April 4, 2025
CONTOUR® CARE
FDA Adverse Event
Malfunction
·ASCENSIA DIABETES CARE US INC.·Product code NBW·March 7, 2025