10 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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IMPRESSION MATERIAL, RUBBER
FDA 510(k)
FDA Class 2
·Dental
YelloPort Elite Port Access System
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
MINICON CONCENTRATOR
FDA 510(k)
FDA Class 1
·Clinical Chemistry
G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code MDS·May 5, 2014
CAPSUREFIX NOVUS
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO, INC.·Product code DTB·October 15, 2012
UNK CLOSUREFAST CATHETER
FDA Adverse Event
Other
·COVIDIEN·Product code GEI·August 2, 2010
UNSPECIFIED BD ALARIS INFUSION SET
FDA Adverse Event
Malfunction
·BECTON DICKINSON·Product code FPA·May 28, 2021
BD ALARIS¿ SECONDARY SET
FDA Adverse Event
Malfunction
·SISTEMAS MEDICOS ALARIS, S.A. DE C.V.·Product code FPA·March 24, 2023
UNSPECIFIED BD ALARIS¿ INFUSION SET
FDA Adverse Event
Malfunction
·SISTEMAS MEDICOS ALARIS, S.A. DE C.V.·Product code FPA·December 29, 2022
Promote Quadra, Sterile EO, Model # / Part #: CD3221-36/100025054, 60019195; CD3223-36P/100013763; CD3239-40/100029115, 100029254, 100037181; CD3239-40Q/100029116, 100029244, 100037115
FDA Enforcement
Class II
·Terminated·St Jude Medical Inc.·July 4, 2018