3,616 results
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19ms
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Sources: EU EUDAMED, US FDA
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Classification: FDA Class 3
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Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D)
FDA Pre-Market Approval
FDA Class 3
·INSYNC FAMILIES OF CRT-ICD'S, INSYNC MAXIMO, INSYNC SENTRY FAMILY, INSYNC II PROTECT, INSYNC III MARQUIS FAMILY, INSYNC
Pulse Generator, Permanent, Implantable
FDA Pre-Market Approval
FDA Class 3
·C/T SERIES/SELECTION/DIAMOND II/JADE II/RUBY II/TOPAZ II/VITA/VITA II/DEMA FAMILY OF IPG
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)
Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Metal/Polymer, Mobile Bearing
FDA Pre-Market Approval
FDA Class 3
·LCS TOTAL KNEE SYSTEM - ADDITION OF POSTERIOR STABILIZED FEMORAL AND BEARING COMPONENTS & RPII TIBIAL TRAYS & BEARING CO
Intraocular Lens
FDA Pre-Market Approval
FDA Class 3
·Sensar/Tecnis 1-Piece IOL, Tecnis Toric IOL, Tecnis Symfony Extended Range of Vision IOL, Tecnis Symfony Toric Extended
Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Metal/Polymer, Mobile Bearing
FDA Pre-Market Approval
FDA Class 3
·LCS TOTAL KNEE SYSTEM - ADDITION OF POSTERIOR STABILIZED FEMORAL AND BEARING COMPONENTS & RPII TIBIAL TRAYS & BEARING CO
Intraocular Lens
FDA Pre-Market Approval
FDA Class 3
·TECNIS Symfony OptiBlue® Extended Range of Vision (ERV) IOL with TECNIS Simplicity® Delivery System, Model DXR00V; TECN
Implantable Cardioverter Defibrillator (Non-Crt)
FDA Pre-Market Approval
FDA Class 3
·CONCERTA, CONSULTA/CONSULTA DF4, & VARIOUS INSYNC FAMILIES OF ICD'S; CONCERTO II, MAXIMO II,PROTECTA,PROTECTA XT CRT-D'S
Lenses, Soft Contact, Extended Wear
FDA Pre-Market Approval
FDA Class 3
·METHAFILCON A AND METHAFILCON B SOFT HYDROPHILIC WEAR CONTACT LENSES INSTALLATION AND VALIDATION OF A NEW 3M ATTEST 290
Implantable Cardioverter Defibrillator (Non-Crt)
FDA Pre-Market Approval
FDA Class 3
·SELECTED FAMILIES OF ICD'S, ENTRUST FAMILY,INTRINSIC FAMILY,ONYX, MAXIMO FAMILY, MARQUIS FAMILY,GEM III FAMILY,GEM II FA
Implant, Dermal, For Aesthetic Use
FDA Pre-Market Approval
FDA Class 3
·RADIESSE INJECTABLE IMPLANT FOR SUB-DERMAL IMPLANTATION FOR RESTORATION AND OR CORRECTION FOR THE SIGNS OF FACIAL FAT LO
Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Metal/Polymer, Mobile Bearing
FDA Pre-Market Approval
FDA Class 3
·LCS TOTAL KNEE SYSTEM - ADDITION OF POSTERIOR STABILIZED FEMORAL AND BEARING COMPONENTS & RPII TIBIAL TRAYS & BEARING CO
Daily Wear Soft Contact Lens To Reduce The Progression Of Myopia
FDA Pre-Market Approval
FDA Class 3
·MiSight 1 Day (omafilcon A) Soft (Hydrophilic) Contact Lenses for Daily Wear
Daily Wear Soft Contact Lens To Reduce The Progression Of Myopia
FDA Pre-Market Approval
FDA Class 3
·MiSight 1 Day (omafilcon A) Soft (Hydrophilic) Contact Lenses for Daily Wear
Daily Wear Soft Contact Lens To Reduce The Progression Of Myopia
FDA Pre-Market Approval
FDA Class 3
·MiSight 1 Day (omafilcon A) Soft (Hydrophilic) Contact Lenses for Daily Wear
Daily Wear Soft Contact Lens To Reduce The Progression Of Myopia
FDA Pre-Market Approval
FDA Class 3
·MiSight 1 Day (omafilcon A)
Daily Wear Soft Contact Lens To Reduce The Progression Of Myopia
FDA Pre-Market Approval
FDA Class 3
·MiSight 1 Day (omafilcon A) Soft (Hydrophilic) Contact Lenses for Daily Wear
Daily Wear Soft Contact Lens To Reduce The Progression Of Myopia
FDA Pre-Market Approval
FDA Class 3
·MiSight 1 Day (omafilcon A) Soft (Hydrophilic) Contact Lenses for Daily Wear
Daily Wear Soft Contact Lens To Reduce The Progression Of Myopia
FDA Pre-Market Approval
FDA Class 3
·MiSight 1 Day (omafilcon A)
Daily Wear Soft Contact Lens To Reduce The Progression Of Myopia
FDA Pre-Market Approval
FDA Class 3
·MiSight 1 Day (omafilcon A) Soft (Hydrophilic) Contact Lenses for Daily Wear