12 results
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19ms
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Sources: EU EUDAMED, US FDA
NEURO CUSTOM SURGICAL KIT
FDA 510(k)
FDA Class 2
·Neurology
MOBILIZATIOIN TABLE
FDA 510(k)
FDA Class 1
·Physical Medicine
TOTAL IGE FAST TEST
FDA 510(k)
FDA Class 2
·Immunology
COBAS 6000 E601 MODULE
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code JJE·October 2, 2025
COBAS E 411 ANALYZER (DISK SYSTEM)
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code JJE·October 6, 2025
COBAS E 411 ANALYZER (RACK SYSTEM)
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code JJE·October 9, 2025
COBAS E 411 ANALYZER (RACK SYSTEM)
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code JJE·June 2, 2025
INTRAMEDULLARY ARTHRODESIS IMPLANT SMART TOE II 19MM / 10° ANGLE FOR PIP ARTHRO
FDA Adverse Event
Malfunction
·STRYKER TRAUMA SELZACH·Product code HTY·June 3, 2014
LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM (UNK SIZE)
FDA Adverse Event
Injury
·ALLERGAN·Product code LTI·November 16, 2012
ENTERRA
FDA Adverse Event
Injury
·MDT PUERTO RICO OPERATIONS CO., JUNCOS·Product code LNQ·September 23, 2010
COBAS E 411 ANALYZER (DISK SYSTEM)
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code JJE·March 31, 2025
Ellipse, Sterile EO, Model #/ Part #: CD1275-36/100116115; CD1275-36Q/100116116; CD1277-36/100048388, 100048391, 100060126, 100116208, 10011636; CD1277-36Q/100048374, 100048394, 100060198, 100098497, 100116268, 100116345; CD1293-36Q/100057838; CD1309-36/100057717; CD1309-36Q/100057718; CD1311-36/100057802, 100060153; CD1311-36Q/100057803, 100060174, 100116264; CD1377-36/100078796, 100079180, 100096847; CD1377-36C/100078612, 100079197, 100079368, 100116120, 100116407, 100116447; CD1377-36Q/100078747, 100079210, 100096848, 100116385, 100116423, 100116427; CD1377-36QC/100078602, 100079199, 100079229, 100116398, 100116409, 100116466,100116485, 100127151, 100127152, 100127153; CD1393-36C/100116461; CD1393-36QC/100080656, 100116339; CD1409-36Q/100080251; CD1411-36C/100080197, 100080232, 100116411, 100116481; CD1411-36Q/100080244, 100080245, 100116338, 100116464; CD1411-36QC/100116337; CD2275-36/100116355; CD2275-36Q/100116349; CD2277-36/100048359, 100048402, 100116206, 100116207; CD2277-36Q/100048377, 100048404,100060190, 100098661, 100116342, 100116350; CD2293-36/100057765; CD2293-36Q/100057766; CD2309-36/100057804; CD2309-36Q/100057763; CD2311-36/100057679, 100060100; CD2311-36Q/100057835, 100060161, 100116351; CD2377-36/100078811, 100079226, 100096774; CD2377-36C/100078601,100079225, 100079304, 100116405, 100116424, 100116484; CD2377-36Q/100078812,100079208, 100096838, 100116406, 100116414, 100116437; CD2377-36QC/100078579, 100079176, 100079352, 100116413, 100116422, 100116436, 100116482, 100127100, 100127154, 100127181; CD2393-36C/100080653, 100116416; CD2393-36QC/100080655, 100116451; CD2409-36C/100079997; CD2409-36Q/100080149; CD2411-36C/100079986, 100080104, 100116118, 100116444; CD2411-36Q/100080180, 100080230, 100116370, 100116420
FDA Enforcement
Class II
·Terminated·St Jude Medical Inc.·July 4, 2018