20 results
·
51ms
·
Sources: EU EUDAMED, US FDA
REGENT LABS, INC.
FDA registration
REGENT LABS, INC.·1 product·🇺🇸 United States
STAIN AWAY PLUS, 8.1 OZ
FDA Adverse Event
Malfunction
·REGENT LABS, INC.·Product code EFT·April 4, 2012
DENTURE CLEANSERS
FDA Adverse Event
Other
·Product code KOL·November 15, 2010
STAIN AWAY PLUS
FDA Adverse Event
REGENT LABS INC.·Product code EFT·March 22, 2012
STAIN AWAY FOR PARTIALS
FDA Adverse Event
Malfunction
·REGENT LABS INC.·Product code EFT·April 21, 2005
KLEENITE
FDA Adverse Event
Injury
·REGENT LABS, INC.·Product code EFT·May 28, 1999
CUSIL
FDA Adverse Event
Injury
·REGENT LABS, INC.·Product code EFT·January 12, 2001
STAIN AWAY PLUS DENTURE CLEANER
FDA Adverse Event
Injury
·REGENT LABS, INC.·Product code EFT·March 9, 2017
SYNCHRON LX20 PRO CLINICAL SYSTEM
FDA Adverse Event
Malfunction
·BECKMAN COULTER, INC.·Product code JJE·December 19, 2008
UNICEL DXC 800 SYNCHRON CLINICAL SYSTEM
FDA Adverse Event
Malfunction
·BECKMAN COULTER, INC.·Product code JJE·September 2, 2011
UNICEL DXC 600I SYNCHRON ACCESS CLINICAL SYSTEM
FDA Adverse Event
Malfunction
·BECKMAN COULTER, INC.·Product code MMI·January 23, 2009
UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM
FDA Adverse Event
Malfunction
·BECKMAN COULTER INC.·Product code JJE·June 20, 2011
UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM
FDA Adverse Event
Malfunction
·BECKMAN COULTER INC.·Product code JJE·June 20, 2011
VITROS Chemistry Product AMYL Slides Reagent, AMYLASE/5 PACK/90 SLDS, Product Code 8112724, UDI # 10758750004393 - Product Usage: For in vitro diagnostic use only to quantitatively measure amylase activity in serum, plasma, and urine using VITROS 250/350/5, 1 FS/4600/XT 3400 Chemistry Systems and VITROS 5600/XT 7600 Integrated Systems.
FDA Recall
Terminated
·Ortho-Clinical Diagnostics·Product code CIW·May 11, 2020
VITROS Chemistry Product AMYL Slides Reagent, AMYLASE/5 PACK/300 SLDS, Product Code 1202670, UDI # 10758750008513 - Product Usage: For in vitro diagnostic use only to quantitatively measure amylase activity in serum, plasma, and urine using VITROS 250/350/5, 1 FS/4600/XT 3400 Chemistry Systems and VITROS 5600/XT 7600 Integrated Systems.
FDA Recall
Terminated
·Ortho-Clinical Diagnostics·Product code CIW·May 11, 2020
SUNGO Europe B.V.
Authorized representative
🇳🇱 Netherlands·1571 Manufacturers·20390 Devices
Intermedical Srl
Importer
🇮🇹 Italy·14 Manufacturers
CEpartner4U
Authorized representative
🇳🇱 Netherlands·160 Manufacturers·5787 Devices
MedNet EC-REP GmbH
Authorized representative
🇩🇪 Germany·464 Manufacturers·5263 Devices
CMC Medical Devices & Drugs SL
Authorized representative
🇪🇸 Spain·698 Manufacturers·11260 Devices