10,000 results
·
30ms
·
Sources: EU EUDAMED, US FDA
Filters
Classification: FDA Class 3
×
Excimer Laser System
FDA Pre-Market Approval
FDA Class 3
·LASERVISION/VISX EXCIMER LASER FOR PRK AND PTK (MOBILEXCIMER)
Implant, Cochlear
FDA Pre-Market Approval
FDA Class 3
·NUCLEUS 22 COCHLEAR IMPLANT SYSTEM FOR ADULTS/ESPRIT 22
Stimulator, Electrical, Implantable, For Incontinence
FDA Pre-Market Approval
FDA Class 3
·INTERSTIM SACRAL NERVE STIMULATION (SNS) THERAPY FOR URINARY CONTROL
Lenses, Soft Contact, Extended Wear
FDA Pre-Market Approval
FDA Class 3
·PURE VISION VISIBILITY TINTED CONTACT LENS FOR EXTENDED WEAR
Lenses, Soft Contact, Extended Wear
FDA Pre-Market Approval
FDA Class 3
·Precision7 , Precision7 for Astigmatism, Precision7 Multifocal, Precision7 Multifocal Toric
Lens, Contact, Orthokeratology, Overnight
FDA Pre-Market Approval
FDA Class 3
·JSZ ORTHOKERATOLOGY (OPRIFOCON A) CONTACT LENSES FOR OVERNIGHT WEAR
Stimulator, Electrical, Implantable, For Incontinence
FDA Pre-Market Approval
FDA Class 3
·MEDTRONIC INTERSTIM THERAPY FOR URINARY CONTROL STIMULATON DESKTOP SOFTWARE
Implant, Cochlear
FDA Pre-Market Approval
FDA Class 3
·NUCLEUS 24 COCHLEAR IMPLANT SYSTEM FOR ADULTS AND CHILDREN
Implant, Cochlear
FDA Pre-Market Approval
FDA Class 3
·RONDO 2 Audio Processor & WaterWear for RONDO 2
Material, Dressing, Surgical, Polylactic Acid
FDA Pre-Market Approval
FDA Class 3
·CollaTape® Absorbable Collagen Wound Dressings for Dental Surgery
Test, Prostate Specific Antigen, Free, (Noncomplexed) To Distinguish Prostate Cancer From Benign Conditions
FDA Pre-Market Approval
FDA Class 3
·DIMENSION FPSA FLEX REAGENT CARTRIDGE
Test, Prostate Specific Antigen, Free, (Noncomplexed) To Distinguish Prostate Cancer From Benign Conditions
FDA Pre-Market Approval
FDA Class 3
·Dimension Vista FPSA Flex reagent cartridge (K6452)
Test, Prostate Specific Antigen, Free, (Noncomplexed) To Distinguish Prostate Cancer From Benign Conditions
FDA Pre-Market Approval
FDA Class 3
·Dimension FPSA Flex Reagent Cartridge
Test, Prostate Specific Antigen, Free, (Noncomplexed) To Distinguish Prostate Cancer From Benign Conditions
FDA Pre-Market Approval
FDA Class 3
·DIMENSION FPSA FLEX REAGENT CARTRIDGE AND DIMENSION VISTA FPSA FLEX REAGENT CARTRIDGE
Test, Prostate Specific Antigen, Free, (Noncomplexed) To Distinguish Prostate Cancer From Benign Conditions
FDA Pre-Market Approval
FDA Class 3
·DIMENSION FPSA FLEX REAGENT CARTRIDGE
Test, Prostate Specific Antigen, Free, (Noncomplexed) To Distinguish Prostate Cancer From Benign Conditions
FDA Pre-Market Approval
FDA Class 3
·Dimension FPSA Flex reagent cartridge (RF451)
Test, Prostate Specific Antigen, Free, (Noncomplexed) To Distinguish Prostate Cancer From Benign Conditions
FDA Pre-Market Approval
FDA Class 3
·DIMENSION FPSA FLEX REAGENT CARTRIDGE
Test, Prostate Specific Antigen, Free, (Noncomplexed) To Distinguish Prostate Cancer From Benign Conditions
FDA Pre-Market Approval
FDA Class 3
·DIMENSION FPSA FLEX REAGENT CATRIDGE
Test, Prostate Specific Antigen, Free, (Noncomplexed) To Distinguish Prostate Cancer From Benign Conditions
FDA Pre-Market Approval
FDA Class 3
·DIMENSION VISTA FPSA FLEX REAGENT CARTRIDGE FOR USE ON THE DIMENSION VISTA 500 SYSTEM
Test, Prostate Specific Antigen, Free, (Noncomplexed) To Distinguish Prostate Cancer From Benign Conditions
FDA Pre-Market Approval
FDA Class 3
·DIMENSION FPSA FLEX REAGENT CARTRIDGE