76 results
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28ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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Prosomnus [CA] Sleep and Snore Device and Prosomnus [CA] Sleep and Snore Device with Micro-recorder
FDA 510(k)
FDA Class 2
·Dental
UniTip High Resolution Catheter
FDA UDI
Unisensor AG·07640172970546·
UniTip High Resolution Catheter
FDA UDI
Unisensor AG·07640172970553·
UniTip High Resolution Catheter
FDA UDI
Unisensor AG·07640172970836·
UniTip High Resolution Catheter
FDA UDI
Unisensor AG·07640172970843·
ATRAMAT PGLA90 POLY(GLYCOLIDE-CO-L-LACTIDE) SURGICAL SUTURES
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
RETCAM 3 OPTHALMIC IMAGING SYSTEM
FDA 510(k)
FDA Class 2
·Ophthalmic
BD HYPODERMIC NEEDLE PRECISIONGLIDE¿ WITHOUT SAFETY
FDA Adverse Event
Malfunction
·BD MEDICAL (BD WEST) MEDICAL SURGICAL·Product code FMI·August 14, 2019
TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT
FDA Adverse Event
Death
·BOSTON SCIENTIFIC CORP.·Product code NIQ·September 8, 2006
TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT
FDA Adverse Event
Death
·BOSTON SCIENTIFIC CORP.·Product code NIQ·September 8, 2006
PIPELINE
FDA Adverse Event
Injury
·COVIDIEN (IRVINE)·Product code OUT·July 11, 2017
PIPELINE
FDA Adverse Event
Injury
·COVIDIEN (IRVINE)·Product code OUT·July 11, 2017
PIPELINE
FDA Adverse Event
Injury
·COVIDIEN (IRVINE)·Product code OUT·July 11, 2017
PULSE GEN MODEL 102
FDA Adverse Event
Injury
·CYBERONICS INC·Product code LYJ·June 17, 2013
CONTAK RENEWAL
FDA Adverse Event
Malfunction
·GUIDANT CRM CLONMEL IRELAND·Product code NIK·July 22, 2011
IAB: 8 FR - 30 CC
FDA Adverse Event
Malfunction
·ARROW INTERNATIONAL INC.·Product code DSP·September 19, 2008
TAXUS EXPRESS2 PACLITAXEL - ELUTING CORONARY S
FDA Adverse Event
Death
·BOSTON SCIENTIFIC CORP.·Product code NIQ·August 1, 2006
Allura Xper FD10C; Model Number: 722001; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563;
FDA Recall
Open, Classified
·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Veenpluis 4-6 Best Netherlands·Product code OWB·September 3, 2025
Allura Xper CV20; Model Numbers: 722031; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563;
FDA Recall
Open, Classified
·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Veenpluis 4-6 Best Netherlands·Product code OWB·September 3, 2025
Allura Xper FD20/20; Model Numbers: 722038; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563;
FDA Recall
Open, Classified
·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Veenpluis 4-6 Best Netherlands·Product code OWB·September 3, 2025