14 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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YOUNG AGAIN
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
NOVO Health Services, LLC
FDA UDI
NOVO HEALTH SERVICES, LLC·00812564033512·Bariatric, Lap Chole
Logical C-Series
FDA UDI
SIGNATURE ORTHOPAEDICS PTY LTD·09348215005009·
POLARIS DS
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
TEST, BLOOD GLUCOSE SYSTEM
FDA 510(k)
FDA Class 2
·Clinical Chemistry
MECTALIF ANTERIOR STAND-ALONE PLATE FLUSH H.12 MM
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code OVD·March 29, 2018
ALARIS SYSTEM
FDA Adverse Event
Malfunction
·CAREFUSION SD·Product code FRN·April 6, 2022
MESH-COMPOSIX KUGEL
FDA Adverse Event
Injury
·DAVOL INC., SUB. C.R. BARD, INC.·Product code FTL·May 16, 2013
CONSULTA CRT-D
FDA Adverse Event
Malfunction
·MEDTRONIC S.A.·Product code NIK·June 14, 2011
SUREFIRE SCORPION
FDA Adverse Event
Malfunction
·ARTHREX ARTHROSCOPY INSTRUMENTS, INC.·Product code MFJ·August 8, 2008
ALIF SCREWDRIVER UNIVERSAL JOINT
FDA Adverse Event
Malfunction
·MEDACTA INTERNATIONAL SA·Product code LXH·January 15, 2016
MECTALIF ANTERIOR SYSTEM
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code OVD·May 6, 2025
MECTALIF ANTERIOR TI-PEEK CAGE
FDA Adverse Event
Malfunction
·MEDACTA INTERNATIONAL SA·Product code OVD·January 4, 2018
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