390 results
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25ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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HIGHTOP Multi-Drug Urine Test Cup, HIGHTOP Multi-Drug Urine Test Cup Rx
FDA 510(k)
FDA Class 2
·Clinical Toxicology
K-Systems
FDA UDI
Coopersurgical, Inc.·00888937025040·G73 Dry Bath Incubator
RIGEL 3DR Anterior Cervical Interbody Fusion System
FDA 510(k)
FDA Class 2
·Orthopedic
ZYNO MEDICAL ADMINISTRATION SET
FDA 510(k)
FDA Class 2
·General Hospital
7600
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS INC.·Product code JAA·October 31, 2008
LIGHTSHEER ET
FDA Adverse Event
Injury
·LUMENIS, INC.·Product code GEX·August 23, 2011
IMPAX CV REPORTING
FDA Adverse Event
Malfunction
·AGFA HEALTHCARE CORP.·Product code LLZ·July 8, 2013
Azurion R1.x and R2.x systems; Model Numbers: (1) 722063, (2) 722064, (3) 722067, (4) 722068, (5) 722078, (6) 722079, (7) 722221, (8) 722222, (9) 722223, (10) 722224, (11) 722225, (12) 722226, (13) 722227, (14) 722228, (15) 722280, (16) 722281, (17) 722282; Software Version: All software versions;
FDA Enforcement
Class II
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·June 18, 2025
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
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
HEATER-COOLER 3T SYSTEM
FDA Adverse Event
Malfunction
·LIVANOVA DEUTSCHLAND GMBH·Product code DWC·January 20, 2026
HEATER-COOLER SYSTEM 3T
FDA Adverse Event
Malfunction
·LIVANOVA DEUTSCHLAND GMBH·Product code DWC·January 23, 2026