24 results
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25ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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VALORY
FDA 510(k)
FDA Class 2
·Radiology
Deltec
FDA UDI
ICU MEDICAL, INC.·10610586033087·
EYE-Q (XYLOFILCON A) SOFT (HYDROPHILIC) MULTIFOCAL CONTACT LENS FOR DAILY WEAR
FDA 510(k)
FDA Class 2
·Ophthalmic
NIPRO HUBER INFUSION, EXCEL HUBER NEEDLE
FDA 510(k)
FDA Class 2
·General Hospital
SJM TRIFECTA VALVE
FDA Adverse Event
Injury
·ST. JUDE MEDICAL CANADA, INC.·Product code LWR·October 30, 2014
CONSULTA CRT-D
FDA Adverse Event
Death
·MEDTRONIC MED REL, INC.·Product code NIK·August 16, 2011
PULSE GEN MODEL UNK
FDA Adverse Event
Injury
·CYBERONICS INC·Product code LYJ·July 9, 2013
SHOULDER SYSTEM
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code PHX·October 7, 2025
SHOULDER SYSTEM
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code PHX·May 5, 2026
COBAS® MPX - 96T
FDA Adverse Event
Malfunction
·ROCHE MOLECULAR SYSTEMS, INC. - BRANCHBURG·Product code QHO·September 26, 2025
GLENOID RECONSTRUCTION SYSTEM
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code PHX·October 15, 2025
SHOULDER SYSTEM
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code PHX·December 20, 2025
SHOULDER SYSTEM
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code PHX·October 22, 2025
GLENOID RECONSTRUCTION SYSTEM
FDA Adverse Event
Malfunction
·MEDACTA INTERNATIONAL SA·Product code PHX·May 26, 2026
SHOULDER SYSTEM
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code PHX·October 29, 2024
GLENOID RECONSTRUCTION SYSTEM
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code PHX·April 14, 2026
ACL ELITE PRO Refurbished)-Analyzer designed specifically for clinical use in the hemostasis laboratory, for coagulation and/or fibrinolysis testing. Part Number: 0001000311R
FDA Recall
Open, Classified
·Instrumentation Laboratory·Product code KFF·February 3, 2023
ACL ELITE PRO-Analyzer designed specifically for clinical use in the hemostasis laboratory, for coagulation and/or fibrinolysis testing. Part Number: 0001000311
FDA Recall
Open, Classified
·Instrumentation Laboratory·Product code KFF·February 3, 2023
ACL ELITE Refurbished-Analyzer designed specifically for clinical use in the hemostasis laboratory, for coagulation and/or fibrinolysis testing. Part Number: 0000880311R
FDA Recall
Open, Classified
·Instrumentation Laboratory·Product code KFF·February 3, 2023
ACL ELITE- Analyzer designed specifically for clinical use in the hemostasis laboratory, for coagulation and/or fibrinolysis testing. Part Number: 0000880311
FDA Recall
Open, Classified
·Instrumentation Laboratory·Product code KFF·February 3, 2023