25 results · 23ms · Sources: EU EUDAMED, US FDA

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THE CMV-IGM TEST

FDA 510(k)
FDA Class 2 ·Microbiology

Kalitec Universal Instruments

FDA UDI
Kalitec Direct LLC·B07301K0604500·Tray, Base, 4.5"

UniTip Catheter

FDA UDI
Unisensor AG·07640172971833·

GEMENI IGM ASSAY

FDA 510(k)
FDA Class 2 ·Immunology

Pleurx Pleural Catheter System

FDA 510(k)
FDA Class 2 ·Cardiovascular

PLEURX LOCKABLE DRAINAGE LINE SET

FDA Adverse Event
Malfunction ·CAREFUSION, INC·Product code DWM·April 2, 2026

2800

FDA Adverse Event
Malfunction ·GE OEC MEDICAL SYSTEMS·Product code JAA·April 15, 2014

ALTRUA

FDA Adverse Event
Injury ·GUIDANT CRM CLONMEL IRELAND·Product code NVZ·October 7, 2010

LIFEVEST WCD 3000 SYSTEM

FDA Adverse Event
Malfunction ·ZOLL LIFECOR CORPORATION·Product code MVK·November 5, 2012

PLEURX DRAINAGE KIT 500ML 10/CS

FDA Adverse Event
Malfunction ·CAREFUSION, INC·Product code DWM·July 25, 2025

PLEURX

FDA Adverse Event
Malfunction ·CAREFUSION, INC·Product code DWM·September 26, 2025

PLEURX DRAINAGE KIT 1000ML

FDA Adverse Event
Malfunction ·CAREFUSION, INC·Product code DWM·January 20, 2026

PLEURX DRAINAGE KIT 1000ML

FDA Adverse Event
Malfunction ·CAREFUSION, INC·Product code DWM·October 15, 2025

VALVE CAP

FDA Adverse Event
Malfunction ·CAREFUSION, INC·Product code DWM·November 5, 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

FDA Adverse Event
Malfunction ·CAREFUSION, INC·Product code DWM·June 2, 2025

PLEURX DRAINAGE KIT 1000ML

FDA Adverse Event
Injury ·CAREFUSION, INC·Product code DWM·February 18, 2025

PLEURX LOCKABLE DRAINAGE LINE KIT

FDA Adverse Event
Injury ·CAREFUSION, INC·Product code DWM·January 5, 2026