9,270 results · 26ms · Sources: EU EUDAMED, US FDA

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval
FDA Class 3 ·HEMA FOR VISTAKON (ETAFILCON A) SOFT HYDROPHILIC CONTACT LENSES

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval
FDA Class 3 ·Comfilcon A Soft (Hydrophilic) contact lenses for extended wear

Material, Dressing, Surgical, Polylactic Acid

FDA Pre-Market Approval
FDA Class 3 ·COLLACOTE COLLATAPE ABSORBABLE COLLAGEN WOUND DRESSING FOR DENTAL SURGERY

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval
FDA Class 3 ·comfilcon A Soft (Hydrophilic) Contact Lenses for Extended Wear

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval
FDA Class 3 ·Precision7 ™, Precision7 ™ for Astigmatism, Precision7 ™ Multifocal, Precision7 ™ Multifocal Toric

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval
FDA Class 3 ·BIOFINITY (COMFILCON A) SOFT CONTACT LENS FOR EXTENDED WEAR

Implant, Cochlear

FDA Pre-Market Approval
FDA Class 3 ·NUCLEUS 22 COCHLEAR IMPLANT SYSTEM FOR CHILDREN/ESPRIT 22

Lens, Contact, Orthokeratology, Overnight

FDA Pre-Market Approval
FDA Class 3 ·BOSTON ORTHOKERATOLOGY (OPRIFOCON A)SHAPING LENS FOR OVERNIGHT WEAR

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval
FDA Class 3 ·HYDRONICS 60 UV IMT CONTACT LENS FOR EXTENDED WEAR

Aid, Surgical, Viscoelastic

FDA Pre-Market Approval
FDA Class 3 ·DUOVISC LABELING INSERT FOR PROVISC(R) SODIUM HYALURONATE PMA

Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval
FDA Class 3 ·SMARTABLATE SYSTEM (FORMERLY STOCKERT 70 SYSTEM FOR CARDIAC ABLATION)

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval
FDA Class 3 ·MEDTRONIC MODEL 6725 PIN-PLUG FOR IS-1 PORT

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