14 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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REHASTIM 2, ERIGOPRO (FES)
FDA 510(k)
FDA Class 2
·Neurology
Oticon
FDA UDI
Oticon A/S·05707131257109·H16, BTE 13 WL 85 CNB
BD GENEOHM VANR ASSAY
FDA 510(k)
FDA Class 2
·Microbiology
VINTAGE PRESS, VINTAGE LF, VINTAGE LF STAIN
FDA 510(k)
FDA Class 2
·Dental
MAXZERO NEEDLELESS CONNECTOR
FDA Adverse Event
Malfunction
·CAREFUSION·Product code FPA·January 6, 2020
LANCET DEVICE SNSRTR CMFRT EN
FDA Adverse Event
Injury
·MEDTRONIC MINIMED·Product code OZO·October 1, 2014
RESTORE ADVANCED
FDA Adverse Event
Injury
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·May 29, 2013
TRANSTAR STRETCHER
FDA Adverse Event
Malfunction
·HILL-ROM, INC.·Product code FPO·June 14, 2011
MAXZERO NEEDLELESS CONNECTOR
FDA Adverse Event
Malfunction
·CAREFUSION·Product code FPA·September 2, 2020
DISCARDIT¿ II SYRINGE W/O NEEDLE
FDA Adverse Event
Malfunction
·BECTON DICKINSON, S.A.·Product code FMF·December 7, 2017
20ML DISCARDIT¿ II SYRINGE W/O NEEDLE
FDA Adverse Event
Malfunction
·BECTON DICKINSON, S.A.·Product code FMF·December 4, 2017
MAXZERO NEEDLELESS CONNECTOR
FDA Adverse Event
Malfunction
·CAREFUSION·Product code FPA·May 8, 2020
MAXZERO NEEDLELESS CONNECTOR
FDA Adverse Event
Malfunction
·CAREFUSION·Product code FPA·May 8, 2020
Brand Name: Optisite Arterial Cannula Product Name: Optisite Arterial Cannula Model/Catalog Number: OPTI18 Software Version: N/A Product Description: Cardiac cannula. The Edwards OptiSite Arterial Perfusion Cannluae provides or establishes arterial perfusion in the extracorporeal circuit for d 6 hours. Component: No
FDA Enforcement
Class I
·Ongoing·Edwards Lifesciences, LLC·July 16, 2025