5,912 results
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30ms
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Sources: EU EUDAMED, US FDA
Filters
Classification: FDA Class 3
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Immunohistochemistry Antibody Assay, C-Kit
FDA Pre-Market Approval
FDA Class 3
·PATHWAY ANTI-C-KIT (9.7) RABBIT MONOCLONAL PRIMARY ANTIBODY
Aid, Surgical, Viscoelastic
FDA Pre-Market Approval
FDA Class 3
·AMVISC 0.8 ML SYRINGE AND AMVISC PLUS, O.8 ML SYRINGE
Somatic Gene Mutation Detection System
FDA Pre-Market Approval
FDA Class 3
·COBAS KRAS MUTATION TEST
Intraocular Lens
FDA Pre-Market Approval
FDA Class 3
·ONE PIECE POSTERIOR CHAMBER IOL
Immunohistochemistry Assay, Antibody, Programmed Death-Ligand 1
FDA Pre-Market Approval
FDA Class 3
·PD-L1 IHC 22C3 pharmDx
Intraocular Lens
FDA Pre-Market Approval
FDA Class 3
·ACRYSOF POSTERIOR CHAMBER INTRAOCULAR LENSES
Lens, Contact (Rigid Gas Permeable), Extended Wear
FDA Pre-Market Approval
FDA Class 3
·FluoroPerm30 (paflufocon C), FluoroPerm60 (paflufocon B), FluoroPerm92 (paflufocon A), Paragon HDS (paflufocon B) Rigid
Lenses, Soft Contact, Extended Wear
FDA Pre-Market Approval
FDA Class 3
·LOTRAFILCON A & LOTRAFILCON B SOFT CONTACT LENSES FOR EXTENDED WEAR
Lenses, Soft Contact, Extended Wear
FDA Pre-Market Approval
FDA Class 3
·VISTAKON (ETAFILCON A) BRAND CONTACT LENSES
Aid, Surgical, Viscoelastic
FDA Pre-Market Approval
FDA Class 3
·VISCOAT Ophthalmic Viscosurgical Device, DUOVISC Ophthalmic Viscoelastic System, and DISCOVISC Ophthalmic Viscosurgic
Intraocular Lens
FDA Pre-Market Approval
FDA Class 3
·MODEL SI-11NB UV ABSORBING SILICONE POSTERIOR IOL
Intraocular Lens
FDA Pre-Market Approval
FDA Class 3
·ZIRCONIA SILICATE BEAD IOL TUMBLE POLISHING
Lenses, Soft Contact, Extended Wear
FDA Pre-Market Approval
FDA Class 3
·DURASOFT(R) 3 FOR EXT WEAR
System, Colorectal Neoplasia, Dna Methylation And Hemoglobin Detection
FDA Pre-Market Approval
FDA Class 3
·COLOGUARD
Intraocular Lens
FDA Pre-Market Approval
FDA Class 3
·CT LUCIA Intraocular Lens (IOL)
Lenses, Soft Contact, Extended Wear
FDA Pre-Market Approval
FDA Class 3
·VISTAKON (senofilcon A) Brand Contact Lenses
Next Generation Sequencing Oncology Panel, Somatic Or Germline Variant Detection System
FDA Pre-Market Approval
FDA Class 3
·FoundationOne Liquid CDx (F1 Liquid CDx)
Intraocular Lens
FDA Pre-Market Approval
FDA Class 3
·CHAMBER LENS MODELS 101, 101B, 101T
Intraocular Lens
FDA Pre-Market Approval
FDA Class 3
·ANTERIOR CHAMBER INTRAOCULAR LENS
Laser, Neodymium:Yag, Ophthalmic For Uses Other Than Posterior Capsulotomy & Cutting Pupillary
FDA Pre-Market Approval
FDA Class 3
·VISULAS ND:YAG LASER