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

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V-PRO® 1 Plus and V-PRO® maX Low Temperature

FDA 510(k)
FDA Class 2 ·General Hospital

UniTip Catheter

FDA UDI
Unisensor AG·07640172971307·

JMS SYSLOC APHERESIS NEEDLE SET

FDA UDI
JMS SINGAPORE PTE LTD·08888483005420·SYSLOC APHERESIS 16GX11/4" BE 30CM W/CLAMP

DIGITAL RADIOGRAPHY CXDI-50C

FDA 510(k)
FDA Class 2 ·Radiology

IMMULITE 2000 CMV IGM, IMMULITE CMV IGM CONTROLS, AND IMMULITE 200 CMV IGM ADJUSTOR MODEL L2KCM2, L2KCM6, LCMC1, LCMC2,

FDA 510(k)
FDA Class 2 ·Microbiology

CAPSUREFIX NOVUS

FDA Adverse Event
Injury ·MPRI·Product code DTB·October 10, 2014

TERUMO CDI 500 BLOOD PARAMETER MONITOR

FDA Adverse Event
Malfunction ·TERUMO CARDIOVASCULAR SYSTEM CORP·Product code DRY·June 20, 2011

CONSULTA CRT-D

FDA Adverse Event
Injury ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code NIK·June 10, 2013

PLEURX LOCKABLE DRAINAGE LINE SET

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

INSPIRE 6F

FDA Adverse Event
Malfunction ·SORIN GROUP ITALIA - S.R.L.·Product code DTZ·October 28, 2025

RESERVOIR INSPIRE 8

FDA Adverse Event
Malfunction ·SORIN GROUP ITALIA SRL·Product code DTZ·May 8, 2026

CONTOUR® PLUS

FDA Adverse Event
Malfunction ·ASCENSIA DIABETES CARE US INC.·Product code NBW·February 20, 2025

PERITX DRAINAGE BAG

FDA Adverse Event
Malfunction ·CAREFUSION, INC·Product code PNG·April 3, 2026

INSPIRE HVR HARDSHELL VENOUS/CARDIOTOMY RESERVOIR

FDA Adverse Event
Injury ·SORIN GROUP ITALIA·Product code DTZ·December 18, 2025

PLEURX DRAINAGE KIT 500ML 10/CS

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

INSPIRE HARD VENOUS RESERVOIR

FDA Adverse Event
Malfunction ·SORIN GROUP ITALIA SRL·Product code DTZ·July 25, 2022

INSPIRE HVR HARDSHELL VENOUS/CARDIOTOMY RESERVOIR

FDA Adverse Event
Injury ·SORIN GROUP ITALIA SRL·Product code DTZ·January 13, 2023

INSPIRE 8 HOLLOW FIBER OXYGENATOR W/ INTEGRATED HARDSHELL VENOUS/CARDIOTOMY RES

FDA Adverse Event
SORIN GROUP ITALIA S.R.L.·Product code DTZ·December 19, 2016

PLEURX DRAINAGE KIT 1000ML

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

INSPIRE HVR

FDA Adverse Event
Malfunction ·SORIN GROUP ITALIA SRL·Product code DTZ·July 21, 2022