7 results · 24ms · Sources: EU EUDAMED, US FDA

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ERYTHROPOIETIN EIA

FDA 510(k)
FDA Class 2 ·Hematology

DISPOSABLE ADJUSTABLE PEEP VALVE MR CONDITIONAL USE

FDA 510(k)
FDA Class 2 ·Anesthesiology

INFINITY MODULAR MONITORS VF4 MODIFICATIONS WITH SCIO, MODELS DELTA, DELTA XL, KAPPA, SC 8000, SC 7000, SC 9000XL

FDA 510(k)
FDA Class 2 ·Cardiovascular

TOTAL ASR ACET IMP SIZE 60

FDA Adverse Event
Injury ·DEPUY INTERNATIONAL LTD. 8010379·Product code KWA·May 27, 2014

ACCU-CHEK SPIRIT CARTRIDGE

FDA Adverse Event
Malfunction ·ROCHE INSULIN DELIVERY SYSTEM INC.·Product code LZG·November 9, 2012

HEARTSTART MRX

FDA Adverse Event
Malfunction ·PHILIPS HEALTHCARE·Product code MKJ·August 31, 2010

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