16 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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ELEKTA NEUROMAG WITH MAXWELL FILTER
FDA 510(k)
FDA Class 2
·Neurology
xMAP® Sheath Fluid PLUS
FDA UDI
LUMINEX CORPORATION·00840487101803·Sheath Fluid PLUS is the delivery medium of the...
OptiLIF Endo, Direct Visualization System
FDA UDI
SPINEOLOGY INC.·M7401050035·TF Endo Tubular Retractor, 6.6mm x 163mm x 30° ...
Humelock II Cemented Shoulder System
FDA UDI
FX SOLUTIONS·03701037306383·STOP DRILL BIT Ø7.5mm L.150
Imaging (ZEOS)
FDA UDI
SANTA BARBARA IMAGING SYSTEMS, INC.·00853460007177·WOLF ADAPTER
NA
FDA UDI
ZIMMER TRABECULAR METAL TECHNOLOGY INC.·00889024311428·
OMNICARE DENTAL IMPLANT SYSTEM
FDA 510(k)
FDA Class 2
·Dental
IVS TUNNELLER
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
BD VACUTAINER® SST¿ II ADVANCE PLUS BLOOD COLLECTION TUBES
FDA Adverse Event
Malfunction
·BECTON, DICKINSON AND COMPANY (BD)·Product code JKA·July 10, 2019
INCEPTA
FDA Adverse Event
Injury
·GUIDANT CRM CLONMEL IRELAND·Product code LWS·April 10, 2013
SPRINT FIDELIS
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO, INC.·Product code LWS·May 8, 2008
M SERIES
FDA Adverse Event
Malfunction
·ZOLL MEDICAL CORP·Product code MKJ·April 1, 2011
SureT G29 6mm, 18", Paradigm; SureT G29 6mm 23"; SureT G29 6mm, 23", Paradigm; SureT G29 6mm 32"' SureT G29 6mm, 32", Paradigm; SureT G29 8mm, 23"; SureT G29 8mm, 23", Paradigm; SureT G29 8mm, 32"; SureT G29 8mm, 32", Paradigm; SureT G29 10mm, 32", Paradigm The products are used in combination with insulin infusion pumps for continuous subcutaneous infusion of insulin
FDA Enforcement
Class II
·Terminated·Unomedical As·November 9, 2016
Belmont Rapid Infuser, a Fluid Management System, Model FMS2000.
FDA Enforcement
Class II
·Terminated·Belmont Instrument Corporation·October 24, 2012
Sure T, contact, contact detach, neria, neria detach, neria multi and thalaset Used in combination with infusion pumps for continuous subcutaneous infusion of medication.
FDA Enforcement
Class II
·Terminated·Unomedical As·July 1, 2015
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