2,325 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Classification: FDA Class 3
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P2psa
FDA Pre-Market Approval
FDA Class 3
·ACCESS HYBRITECH P2PSA REAGENTS ON THE ACCESS IMMUNOASSAY SYSTEMS
Analyzer, Diagnostic, Fiber Optic (Colon)
FDA Pre-Market Approval
FDA Class 3
·OPTICAL BIOPSY(TM) SYSTEM
P2psa
FDA Pre-Market Approval
FDA Class 3
·Access Hybritech p2PSA Reagents on the Access Immunoassay Systems
P2psa
FDA Pre-Market Approval
FDA Class 3
·ACCESS HYBRITECH P2PSA REAGENTS ON THE ACCESS IMMUNOASSAY SYSTEM
P2psa
FDA Pre-Market Approval
FDA Class 3
·ACCESS HYBRITECH P2PSA REAGENTS ON THE ACCESS IMMUNOASSAY SYSTEMS
P2psa
FDA Pre-Market Approval
FDA Class 3
·ACCESS HYBRITECH P2PSA REAGENTS ON THE ACCESS IMMUNOASSAY SYSTEMS
Oximeter, Fetal Pulse
FDA Pre-Market Approval
FDA Class 3
·OXIFIRST FETAL OXYGEN SATURATION MONITORING SYSTEM
Oximeter, Fetal Pulse
FDA Pre-Market Approval
FDA Class 3
·OXIFIRST FETAL OXYGEN SATURATION MONITORING SYSTEM
Analyzer, Diagnostic, Fiber Optic (Colon)
FDA Pre-Market Approval
FDA Class 3
·WAVSTAT OPTICAL BIOPSY SYSTEM
P2psa
FDA Pre-Market Approval
FDA Class 3
·Access Hybritech p2PSA Reagents on the Access Immunoassay Systems
P2psa
FDA Pre-Market Approval
FDA Class 3
·Access Hybritech p2PSA
Temporary Non-Roller Type Right Heart Support Blood Pump
FDA Pre-Market Approval
FDA Class 3
·Impella RP System
Acid, Hyaluronic, Intraarticular
FDA Pre-Market Approval
FDA Class 3
·Monovisc High Molecular Weight Hyaluronan
Temporary Non-Roller Type Right Heart Support Blood Pump
FDA Pre-Market Approval
FDA Class 3
·Impella RP and Impella RP with SmartAssist
Pump, Infusion, Implanted, Programmable
FDA Pre-Market Approval
FDA Class 3
·MEDSTREAM PROGRAMMABLE INFUSION SYSTEM
Implanted Fecal Incontinence Device
FDA Pre-Market Approval
FDA Class 3
·AMS ACTICON NEOSPHINCTER-ARTIFICIAL BOWL SPHINCTER (ABS)
Prosthesis, Penis, Inflatable
FDA Pre-Market Approval
FDA Class 3
·AMS 700 AND AMBICOR INFLATABLE PENILE PROSTHESIS (IPP)
Prosthesis, Penis, Inflatable
FDA Pre-Market Approval
FDA Class 3
·AMS 700 Inflatable Penile Prosthesis, AMS 700 Inflatable Penile Prosthesis with InhibiZone
Antigen(Complexed),Prostate Specific,(Cpsa)
FDA Pre-Market Approval
FDA Class 3
·ADVIA Centaur® and Atellica® IM AFP, ADVIA Centaur® and Atellica® IM PSA, ADVIA Centaur® and Atellica® IM cPSA
Device, Thermal Ablation, Endometrial
FDA Pre-Market Approval
FDA Class 3
·NovaSure Impedance Controlled Endometrial Ablation System