10 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Spectra Q
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
VIDAS® HCG
FDA Adverse Event
Injury
·BIOMERIEUX,SA·Product code JHI·June 17, 2019
ARSENAL PETITE LAPIDUS PLATE, R
FDA Adverse Event
Injury
·TRILLIANT SURGICAL·Product code HRS·April 3, 2020
VIVATRAK
FDA 510(k)
FDA Class 1
·General Hospital
XPERT C. DIFFICILE
FDA 510(k)
FDA Class 1
·Microbiology
NEOCONNECT, Enteral Extension with ENFit connector, REF EXT-60NC The NeoMed NeoConnect Enteral Only Extension Set is intended for use as an extension set for nasogastric/oralgastric or gastric tube enteral feeding tubes, incorporating safety connectors which help mitigate the risk of accidental connection of an I.V. system to the enteral system or the enteral system to an I.V. system. This device is indicated for use in neonatal and pediatric patients in connection with an enteral feeding tube to provide nutrition via nasal or oral gastric placements.
FDA Enforcement
Class III
·Terminated·Neomed Inc·December 12, 2018
INTERSTIM
FDA Adverse Event
Malfunction
·IPG MFG SWITZERLAND·Product code EZW·June 26, 2013
PULSE GEN MODEL 104
FDA Adverse Event
Injury
·CYBERONICS, INC.·Product code LYJ·July 29, 2011
CAROTID WALLSTENT MONORAIL
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC·Product code NIM·September 26, 2008
FLEXCATH ADVANCE STEERABLE SHEATH
FDA Adverse Event
Injury
·MEDTRONIC CRYOCATH LP·Product code DRA·September 15, 2017