1,430 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Classification: FDA Class 3
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System, Test, Tumor Marker, For Detection Of Bladder Cancer
FDA Pre-Market Approval
FDA Class 3
·ALERE NMP22 URINE COLLECTION KIT
System, Test, Tumor Marker, For Detection Of Bladder Cancer
FDA Pre-Market Approval
FDA Class 3
·Alere NMP22 BladderChek Test
System, Test, Tumor Marker, For Detection Of Bladder Cancer
FDA Pre-Market Approval
FDA Class 3
·ALERE NMP22 TEST
System, Test, Tumor Marker, For Detection Of Bladder Cancer
FDA Pre-Market Approval
FDA Class 3
·MATRITECH NMP22 TEST KIT
Kit, Test, Alpha-Fetoprotein For Neural Tube Defects
FDA Pre-Market Approval
FDA Class 3
·AFP RIA KIT
System, Test, Tumor Marker, For Detection Of Bladder Cancer
FDA Pre-Market Approval
FDA Class 3
·NMP22 BLADDERCHEK TEST KIT
System, Test, Tumor Marker, For Detection Of Bladder Cancer
FDA Pre-Market Approval
FDA Class 3
·NMP22 BLADDERCHEK TEST KIT
System, Test, Tumor Marker, For Detection Of Bladder Cancer
FDA Pre-Market Approval
FDA Class 3
·NMP22 BladderChek Test
Lenses, Soft Contact, Extended Wear
FDA Pre-Market Approval
FDA Class 3
·BIOMEDICS UV ASPHERE (OCUFILCON D) CONTACT LENSES FOR EXTENDED WEAR (UP TO 7 DAYS/6 NIGHTS OF EXTENDED WEAR)
Lens, Intraocular, Toric Optics
FDA Pre-Market Approval
FDA Class 3
·enVista One-Piece Hydrophobic Acrylic Toric Intraocular Lens (Model MX60T)
Excimer Laser System
FDA Pre-Market Approval
FDA Class 3
·TECHNOLAS TENEO 317 (MODEL 2) Excimer Laser System
Lenses, Soft Contact, Extended Wear
FDA Pre-Market Approval
FDA Class 3
·O2 OPTIX (LOTRAFILCON B) AND NIGHT AND DAY (LOTRAFILCON A) SOFT CONTACT LENSES FOR EXTENDED WEAR
Intraocular Lens
FDA Pre-Market Approval
FDA Class 3
·Clareon Aspheric Hydrophobic Acrylic Intraocular Lens (IOL), Clareon Toric Aspheric Hydrophobic Acrylic Intraocular Lens
Lenses, Soft Contact, Extended Wear
FDA Pre-Market Approval
FDA Class 3
·CLEAR SOFT (METHAFILCON A) SOFT (HYDROPHILIC) CONTACT LENSES FOR EXTENDED WEAR
Stimulator, Spinal-Cord, Totally Implanted For Pain Relief
FDA Pre-Market Approval
FDA Class 3
·Precision Novi Spinal Cord Stimulator (SCS) System Flash Memory Component Update
Stimulator, Electrical, Implanted, For Parkinsonian Symptoms
FDA Pre-Market Approval
FDA Class 3
·Vercise Deep Brain Stimulation (DBS) System, Vercise PC Deep Brain Stimulation (DBS) System, and Vercise Gevia Deep Brai
Stimulator, Spinal-Cord, Totally Implanted For Pain Relief
FDA Pre-Market Approval
FDA Class 3
·Precision Spinal Cord Stimulator {SCS) Systems
Stimulator, Spinal-Cord, Totally Implanted For Pain Relief
FDA Pre-Market Approval
FDA Class 3
·Precision Spinal Cord Stimulator (SCS) Systems
Stimulator, Spinal-Cord, Totally Implanted For Pain Relief
FDA Pre-Market Approval
FDA Class 3
·PRECISION SPINAL CORD STIMULATOR (SCS) SYSTEM
Stimulator, Electrical, Implanted, For Parkinsonian Symptoms
FDA Pre-Market Approval
FDA Class 3
·Implantable Pluse Generator (IPG): Vercise PC and Vercise Gevia Deep Brain Stimulation (DBS) Systems