484 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Classification: FDA Class 2
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VIDAS D-DIMER NEW (DD2) ASSAY, MODEL 30 442
FDA 510(k)
FDA Class 2
·Hematology
VORTRAN Manometer
FDA 510(k)
FDA Class 2
·Anesthesiology
PORTA-RESP MONITOR
FDA 510(k)
FDA Class 2
·Anesthesiology
SIGMA DIAGNOSTICS AUTO D-DIMER CALIBRATOR, MODEL A7971
FDA 510(k)
FDA Class 2
·Hematology
1ST RESPONSE DISPOSABLE MANOMETER
FDA 510(k)
FDA Class 2
·Anesthesiology
STRATUS CS ACUTE CARE D-DIMER
FDA 510(k)
FDA Class 2
·Hematology
Kit, Test,Alpha-Fetoprotein For Testicular Cancer
FDA Pre-Market Approval
FDA Class 2
·ABBOTT AXSYM AFP (LIST 7A48)
Kit, Test,Alpha-Fetoprotein For Testicular Cancer
FDA Pre-Market Approval
FDA Class 2
·ABBOTT AFP-EIA LABELING CHANGE
Kit, Test,Alpha-Fetoprotein For Testicular Cancer
FDA Pre-Market Approval
FDA Class 2
·ABBOTT AXSYM AFP (LIST 7A48)
Kit, Test,Alpha-Fetoprotein For Testicular Cancer
FDA Pre-Market Approval
FDA Class 2
·ABBOTT AXSYM AFP (LIST 7A48)
Assay, Hybridization And/Or Nucleic Acid Amplification For Detection Of Hepatitis C Rna,Hepatitis C Virus
FDA Pre-Market Approval
FDA Class 2
·COBAS AMPLIPREP/COBAS TAQMAN HCV TEST
Assay, Genotyping, Hepatitis C Virus
FDA Pre-Market Approval
FDA Class 2
·ABBOTT REAL TIME HCV GENOTYPE II, GENOTYPE II CONTROL KIT, ABBOTT MSAMPLE PREPARATION SYSTEM
Assay, Hybridization And/Or Nucleic Acid Amplification For Detection Of Hepatitis C Rna,Hepatitis C Virus
FDA Pre-Market Approval
FDA Class 2
·ABBOTT REAL TIME HCV ASSAY, ABBOTT REAL TIME HCV CALIBRATOR KIT AND CONTROL KIT, ABBOTT MSAMPLE PREPARATION SYSTEM
Assay, Hybridization And/Or Nucleic Acid Amplification For Detection Of Hepatitis C Rna,Hepatitis C Virus
FDA Pre-Market Approval
FDA Class 2
·ABBOTT REALTIME HCV ASSAY
Assay, Genotyping, Hepatitis C Virus
FDA Pre-Market Approval
FDA Class 2
·REALTIME HCV GENOTYPE II
Kit, Test,Alpha-Fetoprotein For Testicular Cancer
FDA Pre-Market Approval
FDA Class 2
·ABBOTT COMMANDER(R) PPC AFP-EIA
Kit, Test,Alpha-Fetoprotein For Testicular Cancer
FDA Pre-Market Approval
FDA Class 2
·ABBOTT IMX AFP ADDITIONAL PURIFICATION STEP
Monitor, Airway Pressure (Includes Gauge And/Or Alarm)
FDA Pre-Market Approval
FDA Class 2
·NON-ABSORBABLE BLACK SILK SUTURE
Suture, Nonabsorbable, Silk
FDA Pre-Market Approval
FDA Class 2
·SILK NONABSORBABLE SUTURES, USP
Suture, Nonabsorbable, Silk
FDA Pre-Market Approval
FDA Class 2
·SILK SUTURE, NONABSORBABLE SURG. SUTURE, USP