29 results · 30ms · Sources: EU EUDAMED, US FDA

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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