17 results
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35ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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PreludeEASE Hydrophilic Sheath Introducer
FDA 510(k)
FDA Class 2
·Cardiovascular
Oticon
FDA UDI
Oticon A/S·05707131287274·RIA2 PRO, MINIRITE 312 WL TC
APEX Revision Knee
FDA UDI
Omni Life Science, Inc.·00841690122807·Modular Stem 25mm x 75mm
IRIS Anterior Cervical Plate System
FDA UDI
Life Spine, Inc.·00190837060794·Iris Fixation Pin
LIN/LIOU ORTHODONTIC MINI ANCHOR SYSTEM (LOMAS) (STERILE)
FDA 510(k)
FDA Class 2
·Dental
VLOC9ABSORBABLE WOUND CLOSURE DEVICE
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
IHEARTEST
FDA Adverse Event
Malfunction
·IHEAR MEDICAL, INC.·Product code EWO·August 17, 2022
KYPHON BONE CEMENT
FDA Adverse Event
Injury
·MEDTRONIC SOFAMOR DANEK USA, INC.·Product code NDN·April 23, 2019
1030489-2019-01423
FDA Adverse Event
Injury
·MEDTRONIC SOFAMOR DANEK·Product code NDN·December 13, 2019
OMNIPOD INSULIN PUMP
FDA Adverse Event
Malfunction
·INSULET CORPORATION·Product code LZG·May 29, 2013
ACCU-CHEK SPIRIT
FDA Adverse Event
Malfunction
·ROCHE INSULIN DELIVERY SYSTEMS INC.·Product code LZG·June 10, 2011
FLEXIMA BILIARY STENT
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC CORPORATION·Product code FGE·September 3, 2008
UNKNOWN VLOC PRODUCT
FDA Adverse Event
Injury
·COVIDIEN, FORMERLY US SURGICAL A DIVISON·Product code GAM·September 29, 2015
UNKNOWN VLOC PRODUCT
FDA Adverse Event
Injury
·COVIDIEN, FORMERLY US SURGICAL A DIVISON·Product code GAM·September 29, 2015
UNKNOWN VLOC PRODUCT
FDA Adverse Event
Injury
·COVIDIEN, FORMERLY US SURGICAL A DIVISON·Product code GAM·September 29, 2015
Micro Screen 6 Panel Cup with Adult (AU), Item No. MSCA-6MBAU
FDA Enforcement
Class III
·Terminated·Ameditech Inc·December 30, 2015
OSTEOCOOL RF ABLATION SYSTEM
FDA Adverse Event
Malfunction
·MEDTRONIC SOFAMOR DANEK USA, INC·Product code GEI·October 21, 2020