29 results
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30ms
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Sources: EU EUDAMED, US FDA
FilmArray Blood Culture Identification (BCID) panel for use with FilmArray Torch
FDA 510(k)
FDA Class 2
·Microbiology
PLEURX LOCKABLE DRAINAGE LINE SET
FDA Adverse Event
Malfunction
·CAREFUSION, INC·Product code DWM·April 2, 2026
MSI Precision Specialty Instruments
FDA UDI
Med Saver, Inc.·00194613084875·K-Wire, Double Ended, Trocar Point, Diameter 0....
MSI Precision Specialty Instruments
FDA UDI
Med Saver, Inc.·00194613084882·K-Wire, Double Ended, Trocar Point, Diameter 0....
3M™ Unitek™
FDA UDI
3M UNITEK CORPORATION·00652221045362·Unitek(TM) Molar Band General Purpose Wide Regu...
PLEURX DRAINAGE KIT 500ML 10/CS
FDA Adverse Event
Malfunction
·CAREFUSION, INC·Product code DWM·July 25, 2025
PLEURX DRAINAGE KIT 1000ML
FDA Adverse Event
Malfunction
·CAREFUSION, INC·Product code DWM·January 20, 2026
MSI Precision Specialty Instruments
FDA UDI
Med Saver, Inc.·00194613084899·K-Wire, Double Ended, Trocar Point, Diameter 0....
PLEURX DRAINAGE KIT 1000ML
FDA Adverse Event
Malfunction
·CAREFUSION, INC·Product code DWM·October 15, 2025
PLEURX DRAINAGE KIT 1000ML
FDA Adverse Event
Malfunction
·CAREFUSION, INC·Product code DWM·September 18, 2025
PLEURX DRAINAGE KIT 500ML 10/CS
FDA Adverse Event
Malfunction
·CAREFUSION, INC·Product code DWM·December 24, 2024
PLEURX DRAINAGE KIT 500ML 10/CS
FDA Adverse Event
Malfunction
·CAREFUSION, INC·Product code DWM·December 24, 2024
PLEURX DRAINAGE KIT 1000ML
FDA Adverse Event
Injury
·CAREFUSION, INC·Product code DWM·February 18, 2025
PLEURX DRAINAGE KIT 1000ML
FDA Adverse Event
Malfunction
·CAREFUSION, INC·Product code PNG·February 24, 2026
PLEURX DRAINAGE KIT 1000ML
FDA Adverse Event
Malfunction
·CAREFUSION, INC·Product code DWM·January 17, 2025
OPUS SPEEDSCREW SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
QUADROSTAR 532
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEM
FDA Adverse Event
Injury
·AV-TEMECULA-CT·Product code NIQ·July 13, 2011
SPRINT QUATTRO SECURE
FDA Adverse Event
Injury
·MPRI·Product code LWS·June 10, 2013
FLO-GARD 6201 VOLUMETRIC INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE·Product code FRN·September 16, 2008