106 results
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20ms
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Sources: EU EUDAMED, US FDA
System, Test, Carcinoembryonic Antigen
FDA Pre-Market Approval
FDA Class 2
·ABBOTT CEA-RIA MONOCLONAL
System, Test, Carcinoembryonic Antigen
FDA Pre-Market Approval
FDA Class 2
·ABBOTT CEA-EIA KIT
System, Test, Carcinoembryonic Antigen
FDA Pre-Market Approval
FDA Class 2
·CEA-RIA MONOCLONAL
System, Test, Carcinoembryonic Antigen
FDA Pre-Market Approval
FDA Class 2
·ABBOTT CEA-EIA
System, Test, Carcinoembryonic Antigen
FDA Pre-Market Approval
FDA Class 2
·ABBOTT CEA-EIA ONE-STEP
System, Test, Carcinoembryonic Antigen
FDA Pre-Market Approval
FDA Class 2
·ABBOTT CEA-EIA
System, Test, Carcinoembryonic Antigen
FDA Pre-Market Approval
FDA Class 2
·ABBOTT CEA-EIA
System, Test, Carcinoembryonic Antigen
FDA Pre-Market Approval
FDA Class 2
·ABBOTT IMX-CEA (LIST 3A33)
System, Test, Carcinoembryonic Antigen
FDA Pre-Market Approval
FDA Class 2
·ABBOTT CEA-EIA KIT
System, Test, Carcinoembryonic Antigen
FDA Pre-Market Approval
FDA Class 2
·ABBOTT AXSYM CEA (LIST 7A47)
ECG Cable Adaptor-for use with V10-0017 (Model TS3)
FDA UDI
VASOMEDICAL, INC.·00817980020900·ECG Cable Adaptor (Model TS3 – for use with V1...
iNSitu™ Hip System
FDA UDI
NEXTSTEP ARTHROPEDIX, LLC·00816127020797·Full Hemisphere Reamer Size 66
SABOURAND DEXTROSE AGAR
FDA 510(k)
FDA Class 1
·Microbiology
Implantable Pulse Generator, Pacemaker (Non-Crt)
FDA Pre-Market Approval
FDA Class 3
·COSMOS(TM) SYSTEM
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·May 23, 2014
INFUSE BONE GRAFT
FDA Adverse Event
Injury
·MEDTRONIC SOFAMOR DANEK USA, INC·Product code NEK·November 13, 2012
FLUOROSCOPY STRETCHER
FDA Adverse Event
Malfunction
·STRYKER CORP., MEDICAL DIV.·Product code FPO·September 7, 2010
Respirator Crash Cart Kit
FDA Enforcement
Class II
·Terminated·ROi CPS LLC·July 8, 2020
Implantable Pulse Generator, Pacemaker (Non-Crt)
FDA Pre-Market Approval
FDA Class 3
·NOVA II MODEL 282-04Y PULSE GENERATOR
Implantable Pulse Generator, Pacemaker (Non-Crt)
FDA Pre-Market Approval
FDA Class 3
·IMPLANTABLE PACEMAKER