753 results
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40ms
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Sources: EU EUDAMED, US FDA
Implantable Cardioverter Defibrillator (Non-Crt)
FDA Pre-Market Approval
FDA Class 3
·Avant, Neutrino NxT, Gallant, and Entrant (NGQ) ICDs and CRT-Ds DF-1 Model Expansion
Implantable Cardioverter Defibrillator (Non-Crt)
FDA Pre-Market Approval
FDA Class 3
·Avant, Neutrino NxT, Gallant, and Entrant (NGQ) ICDs and CRT-Ds DF-1 Model Expansion
Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D)
FDA Pre-Market Approval
FDA Class 3
·Avant, Neutrino NxT, Gallant, and Entrant (NGQ) ICDs and CRT-Ds DF-1 Model Expansion
CLEARVIEW HCG
FDA 510(k)
FDA Class 2
·Clinical Chemistry
ALPHA-1-ACID GLYCOPROTEIN (OROSOMUCOID)
FDA 510(k)
FDA Class 1
·Immunology
CLEARBLUE PREGNANCY TESTING KIT (MODIFICATION)
FDA 510(k)
FDA Class 2
·Clinical Chemistry
TURBOX FIBRINOGEN
FDA 510(k)
FDA Class 2
·Hematology
IMMUNOGLOBULINS G
FDA 510(k)
FDA Class 2
·Immunology
CLEARVIEW STREP A
FDA 510(k)
FDA Class 1
·Microbiology
TURBOX
FDA 510(k)
FDA Class 1
·Immunology
STAPHYTECT-OD
FDA 510(k)
FDA Class 1
·Microbiology
CLEARPLAN
FDA 510(k)
FDA Class 1
·Clinical Chemistry
CLEARVIEW HCG
FDA 510(k)
FDA Class 2
·Clinical Chemistry
APOLIPOPROTEIN A1
FDA 510(k)
FDA Class 1
·Clinical Chemistry
CLEARVIEW POSITIVE AND NEGATIVE HCG URINE CONTROL SET
FDA 510(k)
FDA Class 1
·Clinical Chemistry
CLEARVIEW CHLAMYDIA
FDA 510(k)
FDA Class 1
·Microbiology
CLEARBLUE EASY
FDA 510(k)
FDA Class 2
·Clinical Chemistry
CLEARVIEW HCG SERUM/URINE
FDA 510(k)
FDA Class 2
·Clinical Chemistry
TURBOX ANTITHROMBIN III
FDA 510(k)
FDA Class 2
·Hematology
CLEARVIEW HCG
FDA 510(k)
FDA Class 2
·Clinical Chemistry