392 results
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23ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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Boss Crossing Support Catheter
FDA 510(k)
FDA Class 2
·Cardiovascular
VEO® Lateral Interbody Fusion System
FDA UDI
Choice Spine, LP·00840996134705·LATERAL,CURETTE,CUP,ANGLED,UP
OVATION®
FDA UDI
DENTSPLY SIRONA ORTHODONTICS INC.·D807032206321·OVATION® SS ACU 20X20 UP MD
AMSCO V-PRO 1 LOW/PLUS/MAX TEMPERATURE STERILIZATION SYSTEM
FDA 510(k)
FDA Class 2
·General Hospital
ENGUARD REMOTE PATIENT MONITOR
FDA 510(k)
FDA Class 2
·Cardiovascular
8800
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS INC.·Product code JAA·October 31, 2008
PELORIS TISSUE PROCESSOR
FDA Adverse Event
Malfunction
·LEICA BIOSYSTEMS MELBOURNE·Product code IEO·July 27, 2011
IMPAX CV REPORTING
FDA Adverse Event
Malfunction
·AGFA HEALTHCARE CORPORATION·Product code LLZ·July 8, 2013
Azurion 3 M12 System Model Numbers: (1) 722063, (2) 722221, (3) 722229; Software Version Number - All versions: R1.X, R2.X, R3.X
FDA Enforcement
Class II
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·February 18, 2026
3T HEATER/COOLER
FDA Adverse Event
Malfunction
·LIVANOVA DEUTSCHLAND·Product code DWC·March 19, 2026
HEATER-COOLER SYSTEM
FDA Adverse Event
Malfunction
·LIVANOVA DEUTSCHLAND·Product code DWC·October 1, 2025
MICROLET®
FDA Adverse Event
Malfunction
·ASCENSIA DIABETES CARE US INC.·Product code QRL·April 23, 2026
HEATER-COOLER SYSTEM
FDA Adverse Event
Malfunction
·LIVANOVA DEUTSCHLAND GMBH·Product code DWC·April 30, 2026
HEATER-COOLER SYSTEM 3T
FDA Adverse Event
Malfunction
·LIVANOVA DEUTSCHLAND GMBH·Product code DWC·October 10, 2025
HEATER COOLER 3T SYSTEM
FDA Adverse Event
Malfunction
·LIVANOVA DEUTSCHLAND·Product code DWC·December 3, 2025
HEATER-COOLER SYSTEM 3T
FDA Adverse Event
Malfunction
·LIVANOVA DEUTSCHLAND·Product code DWC·October 10, 2025
HEATER COOLER 3T SYSTEM
FDA Adverse Event
Malfunction
·LIVANOVA DEUTSCHLAND·Product code DTQ·April 22, 2026
HEATER COOLER 3T SYSTEM
FDA Adverse Event
Malfunction
·LIVANOVA DEUSTCHLAND·Product code DWC·April 7, 2026
HEATER-COOLER 3T SYSTEM
FDA Adverse Event
Malfunction
·LIVANOVA DEUTSCHLAND GMBH·Product code DWC·March 26, 2026
HEATER-COOLER 3T SYSTEM
FDA Adverse Event
Malfunction
·LIVANOVA DEUTSCHLAND GMBH·Product code DWC·February 10, 2026