72 results
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17ms
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Sources: EU EUDAMED, US FDA
Filters
Classification: FDA Class 3
×
Next Generation Sequencing Oncology Panel, Somatic Or Germline Variant Detection System
FDA Pre-Market Approval
FDA Class 3
·FoundationOne CDx
Next Generation Sequencing Oncology Panel, Somatic Or Germline Variant Detection System
FDA Pre-Market Approval
FDA Class 3
·FoundationOne CDx
Implanted Brain Stimulator For Epilepsy
FDA Pre-Market Approval
FDA Class 3
·NEUROPACE RNS SYSTEM
Prosthesis, Penis, Inflatable
FDA Pre-Market Approval
FDA Class 3
·AMS 700 Inflatable Penile Prosthesis
Prosthesis, Penis, Inflatable
FDA Pre-Market Approval
FDA Class 3
·AMS 700 Series Product Line/ Implantable Penile Prosthesis (IPP) with and without Inhibizone Treatment
Lenses, Soft Contact, Extended Wear
FDA Pre-Market Approval
FDA Class 3
·Biofinity (comfilcon A) XR Toric and Toric Multifocal Soft (Hydrophilic) Contact Lenses for Extended Wear
Drug Coated Prostatic Dilation Catheter For Benign Prostatic Hyperplasia
FDA Pre-Market Approval
FDA Class 3
·Optilume BPH Catheter System
Drug Coated Prostatic Dilation Catheter For Benign Prostatic Hyperplasia
FDA Pre-Market Approval
FDA Class 3
·Optilume BPH Catheter System
Drug Coated Prostatic Dilation Catheter For Benign Prostatic Hyperplasia
FDA Pre-Market Approval
FDA Class 3
·Optilume BPH Catheter System
Lenses, Soft Contact, Extended Wear
FDA Pre-Market Approval
FDA Class 3
·BIOFINITY XR TORIC AND BIOFINITY XR MULTIFOCAL
Lenses, Soft Contact, Extended Wear
FDA Pre-Market Approval
FDA Class 3
·BIOFINITY XR
Lenses, Soft Contact, Extended Wear
FDA Pre-Market Approval
FDA Class 3
·BIOFINITY ENERGYS ASPHERE, BIOFINITY XR TORIC, BIOFINITY XR MULTIFOCAL
Lenses, Soft Contact, Extended Wear
FDA Pre-Market Approval
FDA Class 3
·Ethos AquaTech Monthly XR, Ethos AquaTech Monthly XR for Astigmatism
Lenses, Soft Contact, Extended Wear
FDA Pre-Market Approval
FDA Class 3
·BIOFINITY XR TORIC
Lenses, Soft Contact, Extended Wear
FDA Pre-Market Approval
FDA Class 3
·Biofinity XR Toric
Lenses, Soft Contact, Extended Wear
FDA Pre-Market Approval
FDA Class 3
·BIOFINITY XR TORIC
Lenses, Soft Contact, Extended Wear
FDA Pre-Market Approval
FDA Class 3
·BIOFINITY XR Toric
Lenses, Soft Contact, Extended Wear
FDA Pre-Market Approval
FDA Class 3
·BIOFINITY XR TORIC
Lenses, Soft Contact, Extended Wear
FDA Pre-Market Approval
FDA Class 3
·Biofinity XR Toric
Lenses, Soft Contact, Extended Wear
FDA Pre-Market Approval
FDA Class 3
·FREQUENCY XCEL TORIC XR