11 results
·
18ms
·
Sources: EU EUDAMED, US FDA
CORNING CONFIRM BLOOD GAS QUALITY CONTRO
FDA 510(k)
FDA Class 1
·Clinical Chemistry
PLATFORM SPLINTS
FDA 510(k)
FDA Class 1
·Physical Medicine
CENTRIFICHEM SYSTEM 500
FDA 510(k)
FDA Class 1
·Clinical Chemistry
M2A 38MM MOD HD +3MM NK
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code LZO·April 4, 2018
TAPERLOC MICROP FMRL 11.0MM
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code JDI·April 4, 2018
EON MINI
FDA Adverse Event
Injury
·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·October 12, 2012
HOMECHOICE PRO
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - LARGO·Product code FKX·May 6, 2014
OT ULTRA2 METER
FDA Adverse Event
Injury
·LIFESCAN, INC.·Product code NBW·August 10, 2010
ZENITH FLEX AAA ENDOVASCULAR GRAFT BIFURCATED MAIN BODY
FDA Adverse Event
Injury
·COOK INC·Product code MIH·August 31, 2023
ZENITH FLEX WITH SPIRAL-Z TECHNOLOGY AAA ENDOVASCULAR GRAFT ILIAC LEG
FDA Adverse Event
Injury
·COOK INC·Product code MIH·August 31, 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