10 results
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19ms
·
Sources: EU EUDAMED, US FDA
CHERMEL BONE CHISELS
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
KMEDIC
FDA UDI
TELEFLEX INCORPORATED·14026704920607·
KMEDIC
FDA UDI
TELEFLEX INCORPORATED·24026704266443·FRAZIER TUBE 7 FRENCH
Cortex Screw, 3.5mm x 24mm, T15, Flex-Thread™
FDA UDI
FLOWER ORTHOPEDICS CORPORATION·00840118117173·Intramedullary fixation screw
FREQUENCY 38 AND SILVER 07 (POLYMACON) SOFT (HYDROPHILIC) CONTACT LENS
FDA 510(k)
FDA Class 2
·Ophthalmic
LX-100 Hair Growth Stimulation System
FDA 510(k)
FDA Class 2
·Physical Medicine
GYNECARE TVT SECUR SYSTEM
FDA Adverse Event
Injury
·ETHICON INC.·Product code PAH·June 2, 2014
PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE
FDA Adverse Event
Death
·MPRI·Product code LWP·November 21, 2012
ACCU CHECK SPIRIT
FDA Adverse Event
Injury
·ROCHE INSULIN DELIVERY SYSTEMS INC.·Product code LZG·September 15, 2010
Fortify Assura, Sterile EO, Model #/ Part #: CD1257-40/100042322, 100059623; CD1257-40Q/100042341, 100059535; CD1259-40/100041914, 100042338, 100059536, 100059646, 100081567; CD1259-40Q/100041931, 100042339, 100059537, 100059620, 100059626, 100078685; CD1263-40/100042948; CD1263-40Q/100042949; CD1357-40C/100080365, 100080377, 100083441; CD1357-40Q/100080389, 100080390, 100083388; CD1359-40/100078740, 100083267, 100096839; CD1359-40C/100078500, 100078969, 100079372, 100079373, 100083442, 100083443, 100117545; CD1359-40Q/100078804, 100079155, 100079413, 100083445, 100096884; CD1359-40QC/100078603, 100079145, 100079146, 100079239, 100083405, 100083444, 100117632, 100127000, 100127065; CD1363-40C/100080349; CD1363-40Q/100080317; CD1391-40C/100080756; CD1391-40QC/100080783; CD2257-40/100042337, 100059839; CD2257-40Q/100042342, 100059842; CD2259-40/100041893, 100042308, 100059794, 100059907, 100082567; CD2259-40Q/100041894, 100042309, 100059845, 100059873, 100078610; CD2263-40/100042950; CD2263-40Q/100043201; CD2357-40C/100080404, 100080413, 100083490; CD2357-40Q/100080319, 100080412, 100083492; CD2359-40/100078750, 100083466; CD2359-40C/100078651, 100079201, 100079240, 100079442, 100083501, 100083502, 100117546; CD2359-40Q/100078841, 100079109, 100083472; CD2359-40QC/100078652, 100079156, 100079157, 100079337, 100083407, 100083465, 100117580, 100127092, 100127103; CD2363-40C/100080416; CD2363-40Q/100080407; CD2391-40C/100080784; CD2391-40QC/100080744
FDA Enforcement
Class II
·Terminated·St Jude Medical Inc.·July 4, 2018