4,594 results
·
40ms
·
Sources: EU EUDAMED, US FDA
Attune Medical
Manufacturer
🇺🇸 United States·4 Basic UDI-DIs·4 Devices·2 Importers·DEKRA Certification B.V.
ensoETM
Device
EU MDD
·
Eu Md Class 2a
·Attune Medical·On the market·32 countries
ensoETM
Device
EU MDD
·
Eu Md Class 2a
·Attune Medical·On the market·32 countries
ensoETM
Device
EU MDD
·
Eu Md Class 2a
·Attune Medical·On the market·32 countries
ensoETM
Device
EU MDD
·
Eu Md Class 2a
·Attune Medical·On the market·32 countries
ENSOETM
FDA Adverse Event
Malfunction
·ATTUNE MEDICAL·Product code PLA·April 4, 2023
DEPUY ATTUNE KNEE SYSTEM
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS, INC.·Product code JWH·November 1, 2018
ENSOETM
FDA Adverse Event
Injury
·ADVANCED COOLING THERAPY INC. D/B/A ATTUNE MEDICAL·Product code PLA·October 10, 2018
ensoETM
Basic UDI-DI
EU MDD
·
Eu Md Class 2a
·Attune Medical·1 device
ensoETM
Basic UDI-DI
EU MDD
·
Eu Md Class 2a
·Attune Medical·1 device
ensoETM
Basic UDI-DI
EU MDD
·
Eu Md Class 2a
·Attune Medical·1 device
ensoETM
Basic UDI-DI
EU MDD
·
Eu Md Class 2a
·Attune Medical·1 device
ENSO ETM UNIVERSAL BITEBLOCK
FDA Adverse Event
Injury
·ATTUNE MEDICAL / ADVANCED COOLING THERAPY, INC.·Product code PLA·June 4, 2024
PALACOS R+G
FDA Adverse Event
Injury
·HERAEUS MEDICAL GMBH·Product code MBB·March 10, 2025
PALACOS R+G
FDA Adverse Event
Injury
·HERAEUS MEDICAL GMBH·Product code MBB·March 10, 2025
ATTUNE CRS FEMORAL LT SZ 7 CEM
FDA Adverse Event
Injury
·DEPUY IRELAND - 9616671·Product code JWH·January 13, 2026
ATTUNE RP TIB BASE SZ 7 POR
FDA Adverse Event
Injury
·DEPUY IRELAND - 961667·Product code NJL·October 9, 2018
ATTUNE RP TIB BASE SZ 5 CEM
FDA Adverse Event
Injury
·DEPUY IRELAND - 9616671·Product code NJL·February 14, 2018
The ATTUNE Rotating Platform (RP) Total Knee System - Product Usage: consists of multiple components intended to replace the femoral, tibial, and patellar articular surfaces of the knee joint.
FDA Recall
Terminated
·DePuy Orthopaedics, Inc.·Product code NJL·February 22, 2021
ATTUNE CR RP INSRT SZ 6 5MM
FDA Adverse Event
Injury
·DEPUY IRELAND 9616671·Product code JWH·September 17, 2018