14 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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SPECTRA OPTIA APHERESIS SYSTEM, SPECTRA OPTIA SYSTEM SOFTWARE, SPECTRA OPTIA EXCHANGE DISPOSABLE SET
FDA 510(k)
FDA Unclassified
·Unknown
AGXO
FDA UDI
Oticon A/S·05707131257161·H160, BTE 13 WL 85 SGR AGXO
Aileron Posterior Fusion System
FDA UDI
Life Spine, Inc.·00190837030803·AILERON Canted Static Posterior Fusion Core, 9m...
Aileron Posterior Fusion System
FDA UDI
Life Spine, Inc.·00190837030810·AILERON Canted Static Posterior Fusion Plate, 9...
ORTHOLOC 3DI ANKLE PLATING SYSTEM, ORTHOLOC BONE SCREW
FDA 510(k)
FDA Class 2
·Orthopedic
QSC-127 SHOULDER ARRAY COIL SET
FDA 510(k)
FDA Class 2
·Radiology
O3 PEDIATRIC SENSOR
FDA Adverse Event
Malfunction
·MASIMO - 15750 ALTON PKWY·Product code MUD·August 20, 2022
O3 PEDIATRIC SENSOR
FDA Adverse Event
Malfunction
·MASIMO - 15750 ALTON PKWY·Product code MUD·August 19, 2022
IMPLANTABLE NEUROSTIMULATOR
FDA Adverse Event
Injury
·MEDTRONIC NEUROMODULATION·Product code EZW·May 29, 2013
INRATIO2
FDA Adverse Event
Malfunction
·ALERE SAN DIEGO, INC.·Product code GJS·June 13, 2011
NUCLEUS 22 CHANNEL COCHLEAR IMPLANT SYSTEM
FDA Adverse Event
Malfunction
·COCHLEAR LTD.·Product code MCM·August 22, 2008
HLM TUBING SET W/SOFTLINE COATING
FDA Adverse Event
Injury
·MAQUET CARDIOPULMONARY AG·Product code DTZ·November 18, 2015
HLM TUBING SET W/SOFTLINE COATING
FDA Adverse Event
Malfunction
·MAQUET CARDIOPULMONARY AG·Product code DTZ·June 3, 2016
HLM TUBING SET W/BIOLINE COATING
FDA Adverse Event
Malfunction
·MAQUET CARDIOPULMONARY AG·Product code DTZ·August 2, 2016