9 results
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26ms
·
Sources: EU EUDAMED, US FDA
IURA UNIVERSAL HOSPITAL STRETCHER-HS-13
FDA 510(k)
FDA Class 2
·General Hospital
MONDEAL
FDA UDI
MONDEAL Medical Systems GmbH·04050435063541·MCD Screw 4.0 x 24 mm M3
lockin...
S9 ELOUERA
FDA 510(k)
FDA Class 2
·Anesthesiology
BioSieve Fentanyl FIA Test Kit; BioSieve ToxiSmart FIA Reader
FDA 510(k)
FDA Class 2
·Clinical Toxicology
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·May 30, 2014
NBCA LIQUID EMBOLIC SYSTEM 2
FDA Adverse Event
Injury
·CORDIS NEUROVASCULAR, INC.·Product code KGG·November 20, 2012
TANDEM T:SLIM INSULIN DELIVERY SYSTEM
FDA Adverse Event
Injury
·TANDEM DIABETES CARE INC.·Product code LZG·June 11, 2015
BD SMARTSITE¿ NEEDLE-FREE VALVE
FDA Adverse Event
Malfunction
·SISTEMAS MEDICOS ALARIS, S.A. DE C.V.·Product code FPA·September 25, 2023
Fortify, Sterile EO, Model #/ Part #: CD1231-40/100029238,100030095, 100041981; CD1231-40Q/100029229, 100030087, 100041982; CD1233-40/100029230, 100029250, 100029259,100031058, 100059778, 100070017; CD1233-40Q/100029260, 100029271, 100029277, 100031104, 100070089; CD1235-40/100029272, 100029282, 100029311, 100031039, 100059779; CD1235-40Q/100029273, 100029295, 100029312, 100030840; CD1241-40/100046351; CD1241-40Q/100046167; CD2231-40/100029274, 100030110, 100041922; CD2231-40Q/100029275, 100030089, 100041923; CD2233-40/100029147, 100029276, 100029313, 100031066, 100037043, 100048759, 100070007; CD2233-40Q/100029148, 100029263, 100029314, 100031067, 100037044, 100059770, 100070068; CD2235-40/100029149, 100029265, 100029283, 100031029, 100059837; CD2235-40Q/100029239, 100029258, 100029284, 100031030, 100066504; CD2241-40/100046148; CD2241-40Q/100046149; CD2299-40/100056952
FDA Enforcement
Class II
·Terminated·St Jude Medical Inc.·July 4, 2018