308 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Classification: FDA Class 3
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Implantable Pacemaker Pulse-Generator
FDA Pre-Market Approval
FDA Class 3
·SYNERGYST II PMA FAMILY OF IMPLANTABLE PULSE GENERATORS
Agent, Absorbable Hemostatic, Non-Collagen Based
FDA Pre-Market Approval
FDA Class 3
·SURGICEL® Absorbable Hemostats (SURGICEL® SNOW)
Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled
FDA Pre-Market Approval
FDA Class 3
·Mentor MemoryShape® Silicone Gel-Filled Breast Implant PMA
Aid, Surgical, Viscoelastic
FDA Pre-Market Approval
FDA Class 3
·DUOVISC LABELING INSERT FOR PROVISC(R) SODIUM HYALURONATE PMA
Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled
FDA Pre-Market Approval
FDA Class 3
·Mentor MemoryGel® Silicone Gel-Filled Breast Implant PMA
Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Ceramic/Metal, Cemented Or Uncemented
FDA Pre-Market Approval
FDA Class 3
·R3 Delta Ceramic Hip System, and POLARSTEM PMA Auxiliary Products
Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled
FDA Pre-Market Approval
FDA Class 3
·MENTOR MEMORYGEL SILICONE GEL-FILLED BREAST IMPLANTS
Prosthesis, Breast, Inflatable, Internal, Saline
FDA Pre-Market Approval
FDA Class 3
·MENTOR SALINE-FILLED AND SPECTRUM BREAST IMPLANT
Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled
FDA Pre-Market Approval
FDA Class 3
·MENTOR MEMORYSHAPE BREAST IMPLANTS
Assays To Detect Pre-Existing Antibodies To Adeno-Associated Virus (Aav) Viral Vectors
FDA Pre-Market Approval
FDA Class 3
·AAV5 DetectCDx®
Assays To Detect Pre-Existing Antibodies To Adeno-Associated Virus (Aav) Viral Vectors
FDA Pre-Market Approval
FDA Class 3
·AAV5 DetectCDx
Prosthesis, Breast, Inflatable, Internal, Saline
FDA Pre-Market Approval
FDA Class 3
·MENTOR SALINE-FILLED AND SPECTRUM BREAST IMPLANTS
Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled
FDA Pre-Market Approval
FDA Class 3
·MENTOR MEMORYSHAPE BREAST IMPLANTS
Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled
FDA Pre-Market Approval
FDA Class 3
·MENTOR MEMORYGEL SILICONE GEL-FILLED BREAST IMPLANTS
Barrier, Absorbable, Adhesion
FDA Pre-Market Approval
FDA Class 3
·GYNECARE INTERCEED ABSORBABLE ADHESION BARRIER
Dorsal Root Ganglion Stimulator For Pain Relief
FDA Pre-Market Approval
FDA Class 3
·Proclaim DRG Systems
Absorbable Collagen Hemostatic Agent With Thrombin
FDA Pre-Market Approval
FDA Class 3
·HEMOBLAST Bellows
Dorsal Root Ganglion Stimulator For Pain Relief
FDA Pre-Market Approval
FDA Class 3
·Proclaim DRG IPG (Model 3664), DRG 50cm leads (models MN10450-50, MN10450-50A), port plug (Model 7108), lead anchor
Absorbable Collagen Hemostatic Agent With Thrombin
FDA Pre-Market Approval
FDA Class 3
·Floseal Hemostatic Matrix
Dorsal Root Ganglion Stimulator For Pain Relief
FDA Pre-Market Approval
FDA Class 3
·St. Jude Medical Clinician Programmer Application, St. Jude Medical Patient Controller Application, Proclaim DRG Implant