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PXI URCD

FDA 510(k)
FDA Class 2 ·Radiology

PXI PNEUMATIC COMPRESSION PADDLE

FDA 510(k)
FDA Class 2 ·Radiology

PXI (PERSONAL X-RAY IMAGER) 512

FDA 510(k)
FDA Class 2 ·Radiology

SHOCKPULSE-SE LITHOTRIPSY SYSTEM

FDA Adverse Event
Malfunction ·GYRUS ACMI, INC.·Product code FEO·April 24, 2025

SAFE-T PLUS THORACENTESIS/PARACENTESIS

FDA Adverse Event
Malfunction ·CAREFUSION, INC·Product code PXI·June 16, 2022

SAFE-T-CENTESIS KIT 6FR X 16CM

FDA Adverse Event
Malfunction ·CAREFUSION, INC·Product code PXI·May 13, 2022

SAFE-T-CENTESIS

FDA Adverse Event
Malfunction ·CAREFUSION 2200, INC·Product code PXI·June 6, 2022

SAFE-T-CENTESIS

FDA Adverse Event
Malfunction ·CAREFUSION 2200, INC·Product code PXI·October 22, 2021

THORA-PARA 5 FRENCH NON-VALVED CATHETER DRAINAGE TRAY

FDA Adverse Event
Injury ·CAREFUSION 2200, INC.·Product code PXI·December 23, 2021

SAFE-T-CENTESIS KIT 6FR X 16CM- PIG1260K

FDA Adverse Event
Malfunction ·CAREFUSION, INC·Product code PXI·June 23, 2021

SAFE-T PLUS THORACENTESIS/PARACENTESIS

FDA Adverse Event
Malfunction ·CAREFUSION, INC·Product code PXI·July 9, 2024

IMPELLA RP

FDA Adverse Event
Injury ·ABIOMED. INC.·Product code PXY·September 15, 2024

SAFE-T PLUS THORACENTESIS/PARACENTESIS

FDA Adverse Event
Malfunction ·CAREFUSION, INC·Product code PXI·July 18, 2024

SAFE-T-CENTESIS KIT 6FR X 16CM

FDA Adverse Event
Malfunction ·CAREFUSION, INC·Product code PXI·September 26, 2024

SAFE-T-CENTESIS 8 FR CATHETER DRAINAGE TRAY

FDA Adverse Event
Malfunction ·UNK·Product code PXI·July 8, 2024

SAFE-T-CENTESIS

FDA Adverse Event
Malfunction ·CAREFUSION 2200, INC·Product code PXI·July 1, 2024

SAFE-T-CENTESIS TRAY 6FR X 16CM

FDA Adverse Event
Malfunction ·CAREFUSION, INC·Product code PXI·August 15, 2024

THORA/PARA TRAY, 5FR, NON-VALVED

FDA Adverse Event
Malfunction ·CAREFUSION, INC·Product code PXI·August 23, 2024

THORA/PARA TRAY, 5FR, NON-VALVED

FDA Adverse Event
Injury ·CAREFUSION, INC·Product code PXI·May 12, 2022

SAFE-T-CENTESIS KIT 8FR X 16CM- PIG1280K

FDA Adverse Event
Malfunction ·CAREFUSION, INC·Product code PXI·June 14, 2022