25 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: 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