985 results
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17ms
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Sources: EU EUDAMED, US FDA
Filters
Classification: FDA Class 3
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Total, Prostate Specific Antigen (Noncomplexed & Complexed) For Detection Of Prostate Cancer
FDA Pre-Market Approval
FDA Class 3
·Elecsys total PSA (100/200 tests) Immunoassay
Test, Prostate Specific Antigen, Free, (Noncomplexed) To Distinguish Prostate Cancer From Benign Conditions
FDA Pre-Market Approval
FDA Class 3
·IMMULITE/IMMULITE 1000/IMMULITE 2000 Free PSA
Antigen(Complexed),Prostate Specific,(Cpsa)
FDA Pre-Market Approval
FDA Class 3
·ADVIA IMS PROSTATE SPECIFIC ANTIGEN ASSAY (PSA)
Test, Prostate Specific Antigen, Free, (Noncomplexed) To Distinguish Prostate Cancer From Benign Conditions
FDA Pre-Market Approval
FDA Class 3
·ACCESS HYBRITECH FREE PSA REAGENT/CALIBRATOR KIT
Test, Prostate Specific Antigen, Free, (Noncomplexed) To Distinguish Prostate Cancer From Benign Conditions
FDA Pre-Market Approval
FDA Class 3
·ACCESS HYBRITECH FREE PSA REAGENT/CALIBRATOR KIT
Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D)
FDA Pre-Market Approval
FDA Class 3
·ST JUDE MEDICAL, MERLIN PSA EX3100 SYSTEM
Test, Prostate Specific Antigen, Free, (Noncomplexed) To Distinguish Prostate Cancer From Benign Conditions
FDA Pre-Market Approval
FDA Class 3
·Atellica IM Prostate-Specific Antigen (PSA) Assay
Total, Prostate Specific Antigen (Noncomplexed & Complexed) For Detection Of Prostate Cancer
FDA Pre-Market Approval
FDA Class 3
·IMMULITE® 2000 Prostate-Specific Antigen (PSA)
Excimer Laser System
FDA Pre-Market Approval
FDA Class 3
·ALLEGRETTO WAVE EYE-Q EXCIMER LASER SYSTEM
Excimer Laser System
FDA Pre-Market Approval
FDA Class 3
·ALLEGRETTO WAVE EYE-Q EXCIMER LASER SYSTEM
Implanted Phrenic Nerve Stimulator For Central Sleep Apnea
FDA Pre-Market Approval
FDA Class 3
·remede® System
Implanted Phrenic Nerve Stimulator For Central Sleep Apnea
FDA Pre-Market Approval
FDA Class 3
·Remede® System
Implanted Phrenic Nerve Stimulator For Central Sleep Apnea
FDA Pre-Market Approval
FDA Class 3
·remede System IPG
Implanted Phrenic Nerve Stimulator For Central Sleep Apnea
FDA Pre-Market Approval
FDA Class 3
·remede System
Implanted Phrenic Nerve Stimulator For Central Sleep Apnea
FDA Pre-Market Approval
FDA Class 3
·remede System
Implanted Phrenic Nerve Stimulator For Central Sleep Apnea
FDA Pre-Market Approval
FDA Class 3
·remede® System
Implanted Phrenic Nerve Stimulator For Central Sleep Apnea
FDA Pre-Market Approval
FDA Class 3
·remede® System
Implanted Phrenic Nerve Stimulator For Central Sleep Apnea
FDA Pre-Market Approval
FDA Class 3
·remede® System
Implanted Phrenic Nerve Stimulator For Central Sleep Apnea
FDA Pre-Market Approval
FDA Class 3
·Remede® System
Implanted Phrenic Nerve Stimulator For Central Sleep Apnea
FDA Pre-Market Approval
FDA Class 3
·remede® System