8 results · 26ms · Sources: EU EUDAMED, US FDA

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LOW PLASTICIZER ADMINISTRATION SETS

FDA 510(k)
FDA Class 2 ·General Hospital

TDS Standard Solution

FDA 510(k)
FDA Class 2 ·Gastroenterology, Urology

MEP-90 HAIR GROWTH STIMULATION SYSTEM

FDA 510(k)
FDA Class 2 ·Physical Medicine

ADVIA CENTAUR XP

FDA Adverse Event
Malfunction ·SIEMENS HEALTHCARE DIAGNOSTICS INC.·Product code NHS·May 5, 2014

ENTRUST AT

FDA Adverse Event
Injury ·MEDTRONIC S.A.·Product code LWS·October 15, 2012

ALLEGRETTO WAVE EYE-Q

FDA Adverse Event
Malfunction ·WAVELIGHT AG (PRESSATH)·Product code LZS·August 6, 2010

PROPONENT DR SL (Model L201)

FDA Enforcement
Class I ·Ongoing·Boston Scientific Corporation·October 22, 2025

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