158 results
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18ms
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Sources: EU EUDAMED, US FDA
Filters
Classification: FDA Class 3
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Sealant, Dural
FDA Pre-Market Approval
FDA Class 3
·DURASEAL DURAL SEALANT SYSTEM
Light Adjustable Lens (Lal) And Light Delivery Device (Ldd)
FDA Pre-Market Approval
FDA Class 3
·Light Adjustable Lens and Light Delivery Device
Prosthesis, Breast, Inflatable, Internal, Saline
FDA Pre-Market Approval
FDA Class 3
·SALINE FILLED BREAST IMPLANT
Device, Hemostasis, Vascular
FDA Pre-Market Approval
FDA Class 3
·MYNX VASCULAR CLOSURE DEVICE
Transcatheter Septal Occluder
FDA Pre-Market Approval
FDA Class 3
·AMPLATZER MUSCULAR VSD OCCLUDER
Occluder, Patent Ductus, Arteriosus
FDA Pre-Market Approval
FDA Class 3
·AMPLATZER SEPTAL OCCLUDER AND MULTI-FENESTRATED SEPTAL OCCLUDER
Occluder, Patent Ductus, Arteriosus
FDA Pre-Market Approval
FDA Class 3
·DUCT OCCLUDER
Light Adjustable Lens (Lal) And Light Delivery Device (Ldd)
FDA Pre-Market Approval
FDA Class 3
·Light Adjustable Lens, Light Delivery Device
Device, Hemostasis, Vascular
FDA Pre-Market Approval
FDA Class 3
·MynxGrip Vascular Closure Device (5F, 6F/7F), Mynx Control Vascular Closure Device (5F, 6F/7F)
System, Endovascular Graft, Aortic Aneurysm Treatment
FDA Pre-Market Approval
FDA Class 3
·TALENT THORACIC STENT GRAFT WITH XCELERANT DELIVERY SYSTEM
System, Endovascular Graft, Aortic Aneurysm Treatment
FDA Pre-Market Approval
FDA Class 3
·ANEURX AAADVANTAGE STENT GRAFT DELIVERY SYSTEM
System, Endovascular Graft, Aortic Aneurysm Treatment
FDA Pre-Market Approval
FDA Class 3
·TALENT ABDOMINAL STENT GRAFT WITH XCELERANT DELIVERY SYSTEM
Device, Hemostasis, Vascular
FDA Pre-Market Approval
FDA Class 3
·DUETT PROSEALING DEVICE (MODEL 1010), DIAGNOSTIC DUETT PRO SEALING DEVICE (MODEL 2210), AND D-STAT FLOWABLE HEMOSTAT...
Absorbable Collagen Hemostatic Agent With Thrombin
FDA Pre-Market Approval
FDA Class 3
·FLOSEAL Hemostatic Matrix/ Floseal Special Applicator Tips
Sealant, Polymerizing
FDA Pre-Market Approval
FDA Class 3
·Coseal Surgical Sealant
Lipoprotein, Low Density, Removal
FDA Pre-Market Approval
FDA Class 3
·LIPOSORBER(R) LA-15 SYSTEM ADSORPTION COLUMN, SULFUX(R) FS-05 PLASMA SEPARATOR, AND TUB. SYST. FOR PLASMAPHER. (LT-MA2).
Acid, Hyaluronic, Intraarticular
FDA Pre-Market Approval
FDA Class 3
·HYALGAN
Ventricular (Assist) Bypass
FDA Pre-Market Approval
FDA Class 3
·HEARTWARE LEFT VENTRICULAR ASSIST DEVICE SYSTEM
Transcatheter Septal Occluder
FDA Pre-Market Approval
FDA Class 3
·GORE Cardioform Septal Occluder and GORE Cardioform ASD Occluder
Glue, Surgical, Arteries
FDA Pre-Market Approval
FDA Class 3
·BioGlue Surgical Adhesive