11 results · 21ms · Sources: EU EUDAMED, US FDA

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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