11 results
·
55ms
·
Sources: EU EUDAMED, US FDA
IMPLANT RESOURCE, INC.
FDA registration
IMPLANT RESOURCE, INC.·5 products·🇺🇸 United States
MPR Slotted Mallet, labeling etched onto devices as follows: Medical Products Resource 800.524.5194 www.m-p-r.com MPR-1120-1000 (01)00840001405868
FDA Recall
Open, Classified
·Implant Resource Inc·Product code HXL·July 21, 2021
MPR Slotted Mallet, labeling etched onto devices as follows: Medical Products Resource 800.524.5194 www.m-p-r.com MPR-1120-1000 (01)00840001405868
FDA Enforcement
Class II
·Ongoing·Implant Resource Inc·October 27, 2021
ENDOWRIST
FDA Adverse Event
Injury
·INTUITIVE SURGICAL, INC·Product code NAY·January 18, 2022
Medtronic Synchromed II Programmable Pump , Medtronic Inc., Minneapolis, MN 55432-5604 40 ml Pumps Model 8637-40 The implantable Medtronic SynchroMed II Programmable Pump is part of the SynchroMed II Infusion System designed to contain and administer prescribed drugs to a specific site. The implantable components of the SynchroMed II Infusion System include the pump, catheter, and catheter accessories.
FDA Recall
Terminated
·Medtronic Neuromodulation·Product code LKK·May 1, 2008
Medtronic Synchromed II Programmable Pump , Medtronic Inc., Minneapolis, MN 55432-5604 20 ml Pumps Model 8637-20 The implantable Medtronic SynchroMed II Programmable Pump is part of the SynchroMed II Infusion System designed to contain and administer prescribed drugs to a specific site. The implantable components of the SynchroMed II Infusion System include the pump, catheter, and catheter accessories.
FDA Recall
Terminated
·Medtronic Neuromodulation·Product code LKK·May 1, 2008
GORE® EXCLUDER® AAA ENDOPROSTHESIS
FDA Adverse Event
Malfunction
·W. L. GORE & ASSOCIATES, INC.·Product code MIH·May 3, 2024
mdi Europa GmbH
Authorized representative
🇩🇪 Germany·132 Manufacturers·4741 Devices
MDSS GmbH
Authorized representative
🇩🇪 Germany·388 Manufacturers·16562 Devices
Obelis s.a.
Authorized representative
🇧🇪 Belgium·546 Manufacturers·18515 Devices
Emergo Europe B.V.
Authorized representative
🇳🇱 Netherlands·900 Manufacturers·22100 Devices