541 results
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27ms
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Sources: EU EUDAMED, US FDA
Filters
Classification: FDA Class 3
×
Lens, Contact (Rigid Gas Permeable), Extended Wear
FDA Pre-Market Approval
FDA Class 3
·Menicon Z (tisilfocon) Rigid Gas Permeable Contact Lens and Menicon Z Night (tisilfocon A) Contact Lenses for Overnight
Lens, Contact (Rigid Gas Permeable), Extended Wear
FDA Pre-Market Approval
FDA Class 3
·MENICON SF-P RGP (MELAFOCON A) CONTACT LENS
Lens, Contact (Rigid Gas Permeable), Extended Wear
FDA Pre-Market Approval
FDA Class 3
·BOSTON ORTHOKERATOLOGY SHAPING LENS FOR OVERNIGHT WEAR
Lens, Contact (Rigid Gas Permeable), Extended Wear
FDA Pre-Market Approval
FDA Class 3
·RIGID GAS PERMEABLE CONTACT LENS
Lens, Contact (Rigid Gas Permeable), Extended Wear
FDA Pre-Market Approval
FDA Class 3
·BOSTON EQUALENS (ITAFLUOROFOCON A) RIGID GAS PERMEABLE CONTACT LENS, EQUALENS 2 (OPRIFOCON A) RIGID GAS PERMEARABLE LENS
Lens, Contact (Rigid Gas Permeable), Extended Wear
FDA Pre-Market Approval
FDA Class 3
·Paragon HDS® (paflufocon B), FluoroPerm® 151 (paflufocon D), Paragon HDS® 100 (paflufocon D) Rigid Gas Permeable Contac
Lens, Contact (Rigid Gas Permeable), Extended Wear
FDA Pre-Market Approval
FDA Class 3
·PARAPERM E.W. BLUE RIGID GAS PERMEABLE CONTACT LEN
Lens, Contact (Rigid Gas Permeable), Extended Wear
FDA Pre-Market Approval
FDA Class 3
·Paragon HDS100 and Fluoroperm 151 Rigid Gas Permeable Contact Lenses in clear and tints
Lens, Contact (Rigid Gas Permeable), Extended Wear
FDA Pre-Market Approval
FDA Class 3
·Boston Equalens (itafluorofocon A) Rigid Gas Permeable Contact Lens, Boston Equalens II (oprifocon A) Rigid Gas Permeabl
Lens, Contact (Rigid Gas Permeable), Extended Wear
FDA Pre-Market Approval
FDA Class 3
·BOSTON EQUALENS/EQUALENS II
Replacement Heart-Valve
FDA Pre-Market Approval
FDA Class 3
·CARPENTIER-EDWARDS PERIMOUNT MAGNA EASE MITRAL BIOPROSTHESES, MODELS 7100 AND 7100TFX
COAXIAL BALLOON URETHRAL DILATOR
FDA 510(k)
FDA Class 3
·Unknown
Replacement Heart-Valve
FDA Pre-Market Approval
FDA Class 3
·Carpentier-Edwards PERIMOUNT Magna Ease Pericardial Aortic Bioprosthesis with ThermaFix tissue process
Replacement Heart-Valve
FDA Pre-Market Approval
FDA Class 3
·CARPENTIER-EDWARDS PERIMOUNT MAGNA MITRAL EASE PERICARDIAL BIOPROSTHESIS WITH THERMAFIX TISSUE PROCESS
Absorbable Collagen Hemostatic Agent With Thrombin
FDA Pre-Market Approval
FDA Class 3
·Floseal Hemostatic Matrix, Floseal with Recothrom, Floseal Hemostatic Matrix, Floseal Fast Prep
Replacement Heart-Valve
FDA Pre-Market Approval
FDA Class 3
·CAPENTIER-EDWARDS PERIMOUNT THEON, THEON PSR, MAGNA, MAGNA EASE, PERICARDIAL AORTIC BIOPROSTHESIS
Replacement Heart-Valve
FDA Pre-Market Approval
FDA Class 3
·CAPENTIER-EDWARDS PERIMOUNT THEON, THEON PSR, MAGNA, MAGNA EASE, PERICARDIAL AORTIC BIOPROSTHESIS
Replacement Heart-Valve
FDA Pre-Market Approval
FDA Class 3
·Carpentier-Edwards PERIMOUNT Magna Ease Pericardial Aortic Bioprosthesis with ThermaFix tissue process
Absorbable Collagen Hemostatic Agent With Thrombin
FDA Pre-Market Approval
FDA Class 3
·Floseal Hemostatic Matrix, RT5 and RTl 0, Floseal Hemostatic Matrix, Fast Prep
Replacement Heart-Valve
FDA Pre-Market Approval
FDA Class 3
·CARPENTIER-EDWARDS PERIMOUNT MAGNA MITRAL EASE PERCARDIAL BIOPRSTHESIS MODELS 7300 AND 7300TFX