11 results
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21ms
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Sources: EU EUDAMED, US FDA
BD Intelliport System; BD Intelliport Reader (516230); BD Intelliport Sensor (516229); BD Intelliport Gateway (516232); BD Intelliport Mount (516233); BD Intelliport Charger (516231)
FDA 510(k)
FDA Class 2
·General Hospital
MSI Precision Specialty Instruments
FDA UDI
Med Saver, Inc.·00194613018009·K-Wire, Single Ended, Trocar Point, Diameter Si...
Oph. Cystotomes
FDA UDI
KATENA PRODUCTS, INC.·00841668113684·CYSTOTOME FORMED 27GA
MODEL SR-130-D PORTABLE DIGITAL X-RAY SYSTEM
FDA 510(k)
FDA Class 2
·Radiology
Optiflux Series of Dialyzers F160NR, F180NR, F200NR
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
DRILL BIT Ø4.2 CALIBR L145 3FLUTE W/COUP
FDA Adverse Event
Malfunction
·SYNTHES SELZACH·Product code HTW·October 25, 2017
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·September 2, 2025
UNKNOWN DEPUY KNEE
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS, INC.·Product code JWH·November 21, 2008
UNIFY CRT-D
FDA Adverse Event
Injury
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code NIK·September 11, 2011
UV FLASH TRANSFER SET
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code KDJ·July 23, 2013
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