10 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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ENDO GIA RELOAD
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
KONICA MINOLTA XPRESS DIGITAL MAMMOGRAPHY SYSTEM
FDA 510(k)
FDA Class 2
·Radiology
SYNTHES VARIABLE ANGLE LCP ELBOW SYSTEM (MEDICAL AND POSTEROLATERAL DISTAL HUMERUS PLATES)
FDA 510(k)
FDA Class 2
·Orthopedic
MINICAP
FDA Adverse Event
Injury
·BAXTER HEALTHCARE - CLEVELAND·Product code KDI·May 24, 2013
FOLFUSOR
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - IRVINE·Product code MEB·September 30, 2014
SPRINT QUATTRO SECURE
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO, INC.·Product code LWS·June 16, 2011
VENTED HUMIDIFICATION CHAMBER
FDA Adverse Event
Malfunction
·FISHER & PAYKEL HEALTHCARE LTD·Product code BTT·July 24, 2014
THERAKOS CELLEX Photopheresis Procedural Kit PRODUCT CODE: CLXUSA
FDA Enforcement
Class II
·Ongoing·Therakos, Inc.·November 17, 2021
HANDLE CEV669B DIA 5MM ANG BIPOLAR
FDA Adverse Event
Malfunction
·XOMED MICROFRANCE MFG·Product code GEI·May 30, 2014
Eversense CGM SENSOR (FG-4200-00-301)-Continuous Glucose Monitor
FDA Enforcement
Class II
·Terminated·Senseonics, Inc.·November 6, 2019