27 results
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31ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Double Flexible Tipped Wire Guides
FDA 510(k)
FDA Class 2
·Cardiovascular
ZenFlex
FDA UDI
Kerr Corporation·00195062029653·Rotary Files
NON-STERILE POWDER- FREE PEACH COLOR, NITRILE EXAMINATION GLOVES WITH LANO-E AND PEPPERMINT CITRUS SCENT
FDA 510(k)
FDA Class 1
·General Hospital
MODIFICATION TO JOURNEY UNICONDYLAR FEMORAL IMPLANT
FDA 510(k)
FDA Class 2
·Orthopedic
RESOLUTE INTEGRITY RX
FDA Adverse Event
Injury
·MEDTRONIC IRELAND·Product code NIQ·October 15, 2018
RESOLUTE INTEGRITY RX
FDA Adverse Event
Death
·MEDTRONIC IRELAND·Product code NIQ·October 15, 2018
DR FOG TREATED SPONGE, STERILE
FDA Adverse Event
Malfunction
·ASPEN SURGICAL PRODUCTS, CALEDONIA·Product code OCT·August 6, 2019
OSSEOTITE TAPERED IMPLANT 4 X 8.5MM
FDA Adverse Event
Injury
·BIOMET 3I·Product code DZE·October 18, 2024
OSSEOTITE TAPERED IMPLANT 4 X 8.5MM
FDA Adverse Event
Injury
·BIOMET 3I·Product code DZE·October 18, 2024
PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)
FDA Adverse Event
Malfunction
·INVACARE FLORIDA OPERATIONS·Product code CAW·October 17, 2014
LAMITRODE 44 60-CM LENGTH PADDLE LEAD
FDA Adverse Event
Injury
·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·July 21, 2011
HOMECHOICE AUTOMATED PD SET WITH CASSETTE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·June 21, 2013
IMPEDE-FX EMBOLIZATION PLUG
FDA Adverse Event
Malfunction
·SHAPE MEMORY MEDICAL INC.·Product code KRD·February 28, 2023
IMPEDE-FX EMBOLIZATION PLUG
FDA Adverse Event
Malfunction
·SHAPE MEMORY MEDICAL INC.·Product code KRD·May 7, 2024
IMPEDE-FX EMBOLIZATION PLUG
FDA Adverse Event
Malfunction
·SHAPE MEMORY MEDICAL INC.·Product code KRD·August 21, 2023
IMPEDE-FX EMBOLIZATION PLUG
FDA Adverse Event
Malfunction
·SHAPE MEMORY MEDICAL, INC.·Product code KRD·November 19, 2021
IMPEDE-FX EMBOLIZATION PLUG
FDA Adverse Event
Malfunction
·SHAPE MEMORY MEDICAL INC.·Product code KRD·February 16, 2024
IMPEDE-FX EMBOLIZATION PLUG
FDA Adverse Event
Malfunction
·SHAPE MEMORY MEDICAL INC.·Product code KRD·November 27, 2024
IMPEDE-FX EMBOLIZATION PLUG
FDA Adverse Event
Malfunction
·SHAPE MEMORY MEDICAL·Product code KRD·October 1, 2024
IMPEDE-FX EMBOLIZATION PLUG
FDA Adverse Event
Malfunction
·SHAPE MEMORY MEDICAL, INC.·Product code KRD·June 19, 2025