392 results · 23ms · Sources: EU EUDAMED, 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