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

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Sterisheet Sterilization Wrap

FDA 510(k)
FDA Class 2 ·General Hospital

AP-1000 BLOOD GLUCOSE MONITORING SYSTEM, MODEL AP-1000, MAJOR GLUCOSE CONTROL SOLUTION

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

PRO-DENSE BONE VOID FILLER

FDA 510(k)
FDA Class 2 ·Orthopedic

PLEURX LOCKABLE DRAINAGE LINE SET

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

GLIDEWIRE GT

FDA Adverse Event
Injury ·TERUMO CORPORATION, ASHITAKA·Product code DQX·March 30, 2026

530G INSULIN PUMP

FDA Adverse Event
Injury ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OZO·October 14, 2014

COLLEAGUE PRE P1.7

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·July 21, 2011

LIFEVEST WCD 4000 SYSTEM

FDA Adverse Event
Malfunction ·ZOLL LIFECOR CORPORATION·Product code MVK·May 24, 2013

GLIDEWIRE GT

FDA Adverse Event
Injury ·TERUMO CORPORATION, ASHITAKA·Product code DQX·May 29, 2026

PERITX DRAINAGE BAG

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

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

RADIFOCUS GLIDEWIRE

FDA Adverse Event
Injury ·TERUMO CORPORATION, ASHITAKA·Product code DQX·November 26, 2025

PLEURX DRAINAGE KIT 1000ML

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

PERITX DRAINAGE BAG KIT

FDA Adverse Event
Malfunction ·CAREFUSION, INC·Product code PNG·December 18, 2025

TERUMO RADIFOCUS GUIDE WIRE

FDA Adverse Event
Malfunction ·TERUMO CORPORATION, ASHITAKA·Product code DQX·July 3, 2025

PLEURX DRAINAGE KIT 1000ML

FDA Adverse Event
Malfunction ·CAREFUSION, INC·Product code DWM·September 18, 2025

PERITX DRAINAGE BAG

FDA Adverse Event
Malfunction ·CAREFUSION, INC·Product code PNG·April 11, 2026

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