23 results
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41ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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ANNE Chest
FDA 510(k)
FDA Class 2
·Cardiovascular
GE LOGIQ 9 DIAGNOSTIC ULTRASOUND SYSTEM, MODEL 2404587
FDA 510(k)
FDA Class 2
·Radiology
UNIVERSAL DIGITAL INTERFACE 2, UDI 2
FDA 510(k)
FDA Class 2
·Radiology
BD PARADIGM LINK BLOOD GLUCOSE MONITOR
FDA Adverse Event
Other
·BECTON DICKINSON·Product code NBW·February 10, 2005
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·August 28, 2025
BD SYRINGE 50ML LL TIP 1ML
FDA Adverse Event
Malfunction
·BD MEDICAL (BD WEST) MEDICAL SURGICAL·Product code FMF·February 26, 2020
FLO-GARD 6301 VOLUMETRIC INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE·Product code FPA·November 24, 2008
COLLEAGUE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·September 9, 2011
INTERSTIM II
FDA Adverse Event
Malfunction
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code EZW·July 22, 2013
Injection needle, bayonet, Luer-Lock, 1. Model no. 50-353-23, working length 25 cm, total length 31cm, nonsterile; 2. Model no. 50-345-23, working length 24 cm, total length 31 cm, non-sterile
FDA Enforcement
Class II
·Ongoing·Spiggle & Theis Mt Gmbh·August 27, 2025
DENALI JUGULAR SYSTEM
FDA Adverse Event
Malfunction
·BARD PERIPHERAL VASCULAR, INC.·Product code DTK·December 27, 2023
THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER
FDA Adverse Event
Injury
·BIOSENSE WEBSTER INC·Product code LPB·March 18, 2024
DENALI JUGULAR SYSTEM
FDA Adverse Event
Malfunction
·BARD PERIPHERAL VASCULAR, INC.·Product code DTK·November 21, 2023
DENALI FEMORAL SYSTEM
FDA Adverse Event
Malfunction
·BARD PERIPHERAL VASCULAR, INC.·Product code DTK·December 10, 2023
DENALI FEMORAL SYSTEM
FDA Adverse Event
Injury
·BARD PERIPHERAL VASCULAR, INC.·Product code DTK·December 20, 2023
DENALI JUGULAR SYSTEM
FDA Adverse Event
Malfunction
·BARD PERIPHERAL VASCULAR, INC.·Product code DTK·October 26, 2023
DENALI FEMORAL SYSTEM
FDA Adverse Event
Malfunction
·BARD PERIPHERAL VASCULAR, INC.·Product code DTK·December 6, 2023
DENALI FEMORAL SYSTEM
FDA Adverse Event
Malfunction
·BARD PERIPHERAL VASCULAR, INC.·Product code DTK·December 20, 2023
DENALI FEMORAL SYSTEM
FDA Adverse Event
Injury
·BARD PERIPHERAL VASCULAR, INC.·Product code DTK·December 11, 2023
DENALI FEMORAL SYSTEM
FDA Adverse Event
Malfunction
·BARD PERIPHERAL VASCULAR, INC.·Product code DTK·November 7, 2023