115 results
·
29ms
·
Sources: EU EUDAMED, US FDA
System, Test, Carcinoembryonic Antigen
FDA Pre-Market Approval
FDA Class 2
·CEA-ROCHE(R) EIA
System, Test, Carcinoembryonic Antigen
FDA Pre-Market Approval
FDA Class 2
·CEA-ROCHE(R) EIA
System, Test, Carcinoembryonic Antigen
FDA Pre-Market Approval
FDA Class 2
·CEA-ROCHE(R) EIA
System, Test, Carcinoembryonic Antigen
FDA Pre-Market Approval
FDA Class 2
·CEA-ROCHE(R) EIA
System, Test, Carcinoembryonic Antigen
FDA Pre-Market Approval
FDA Class 2
·CEA-ROCHE(R) EIA
System, Test, Carcinoembryonic Antigen
FDA Pre-Market Approval
FDA Class 2
·CEA-ROCHE(R) EIA
System, Test, Carcinoembryonic Antigen
FDA Pre-Market Approval
FDA Class 2
·CEA-ROCHE(R) EIA
NUCLEUS 22
FDA Adverse Event
Injury
·COCHLEAR LIMITED·Product code MCM·May 18, 2025
NA
FDA UDI
Richard Wolf GmbH·04055207043585·TEM OBTURATOR Ø 36MM WL 175MM WL 175mm, reusable
NAR
FDA UDI
NORTH AMERICAN RESCUE, LLC·10842209121820·
NUCLEUS 22 CHANNEL COCHLEAR IMPLANT SYSTEM
FDA Adverse Event
Malfunction
·COCHLEAR LTD.·Product code MCM·August 23, 2016
OPERATING ROOM STAND
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
Sealant, Dural
FDA Pre-Market Approval
FDA Class 3
·SpineSeal Spine Sealant
Shunt, Portosystemic, Endoprosthesis
FDA Pre-Market Approval
FDA Class 3
·GORE VIATORR TIPS
COULTER LH 500 HEMATOLOGY ANALYZER
FDA Adverse Event
Malfunction
·BECKMAN COULTER·Product code GKZ·May 30, 2014
INFUSE BONE GRAFT
FDA Adverse Event
Injury
·MEDTRONIC SOFAMOR DANEK USA, INC·Product code NEK·November 20, 2012
ENDOPATH** XCEL* STABILITY SLEEVE FOR BLADELESS TROCAR
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, LLC.·Product code GCJ·September 21, 2010
Shunt, Portosystemic, Endoprosthesis
FDA Pre-Market Approval
FDA Class 3
·GORE VIATORR TIPS ENDOPROSTHESIS
Shunt, Portosystemic, Endoprosthesis
FDA Pre-Market Approval
FDA Class 3
·GORE VIATORR TIPS ENDOPROSTHESIS
Shunt, Portosystemic, Endoprosthesis
FDA Pre-Market Approval
FDA Class 3
·GORE VIATORR TIPS ENDOPROSTHESIS