44 results
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24ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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CONSENSUS BIOLOX DELTA CERAMIC FEMORAL HEAD
FDA 510(k)
FDA Class 2
·Orthopedic
Fletcher CT/MR Applicator
FDA UDI
Nucletron B.V.·08717213035218·Micro Ovoid (left) 15mm, R7.5
MYSTIQUE® MB
FDA UDI
DENTSPLY SIRONA ORTHODONTICS INC.·D807K110532101·MYSTIQUE® MB RT RX 022 U 5-5/L3-3 CS HK
SNN SYSTEM INCLUDING THE TOMOGUIDE OPTION
FDA 510(k)
FDA Class 2
·Neurology
CONSENSUS REVISION KNEE SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
TELAMON FUSION DEVICE
FDA Adverse Event
Injury
·MEDTRONIC SOFAMOR DANEK·Product code MAX·August 5, 2016
LIGACLIP*MCA LARGE APPLIER
FDA Adverse Event
Death
·ETHICON ENDO-SURGERY, LLC.·Product code GDO·July 7, 2022
TELAMON® FUSION DEVICE
FDA Adverse Event
Injury
·MDT SOFAMOR DANEK PUERTO RICO MFG·Product code MAX·August 3, 2012
TELAMON® FUSION DEVICE
FDA Adverse Event
Injury
·MSD DEGGENDORF MFG·Product code MAX·August 3, 2012
CONCERTO + BASIC
FDA Adverse Event
Malfunction
·Product code ILJ·April 4, 2013
INTER-CRANIAL PRESSURE AND TEMPERATURE MONITOR
FDA Adverse Event
Malfunction
·INTEGRA LIFESCIENCES (IRELAND) LIMITED·Product code GWM·September 16, 2014
VOYAGER NC CORONARY DILATATION CATHETER
FDA Adverse Event
Injury
·AV-TEMECULA-CT·Product code LOX·June 1, 2011
SPECIFIC DEVICE NOT REPORTED
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code JWH·October 22, 2024
LOGIC TIBIA IMPLANT PSC INSERT, SZ 5, 13MM
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code JWH·April 13, 2023
SPECIFIC DEVICE NOT REPORTED
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code JWH·December 17, 2024
LOGIC FEMORAL PS CEM LEFT SZ 3.5
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code JWH·March 5, 2025
LOGIC TIBIA IMPLANT PSC INSERT, SZ 4, 9MM
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code JWH·June 30, 2022
LOGIC TIBIA IMPLANT PSC INSERT, SZ 3.5, 11MM
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code JWH·September 5, 2024
LOGIC TIBIA IMPLANT PSC INSERT, SZ 1, 13MM
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code JWH·September 11, 2024
SPECIFIC DEVICE NOT REPORTED
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code JWH·October 22, 2024