694 results · 18ms · Sources: EU EUDAMED, US FDA

Intraocular Lens

FDA Pre-Market Approval
FDA Class 3 ·SM-1, CR-1, & GR-1 IOLS

Intraocular Lens

FDA Pre-Market Approval
FDA Class 3 ·SM-1, CR-1, & GR-1 IOLS

Intraocular Lens

FDA Pre-Market Approval
FDA Class 3 ·SM-1, CR-1, & GR-1 IOLS

Intraocular Lens

FDA Pre-Market Approval
FDA Class 3 ·CR-1, CR-1, & GR-1 IOLS

Intraocular Lens

FDA Pre-Market Approval
FDA Class 3 ·SM-1, CR-1, & GR-1 IOLS

Intraocular Lens

FDA Pre-Market Approval
FDA Class 3 ·SM-1, CR-1, & GR-1 IOLS

Intraocular Lens

FDA Pre-Market Approval
FDA Class 3 ·SM-1, CR-1, & GR-1 IOLS

Intraocular Lens

FDA Pre-Market Approval
FDA Class 3 ·SM-1, CR-1, & GR-1 IOLS

Defibrillator, Implantable, Dual-Chamber

FDA Pre-Market Approval
FDA Class 3 ·PARADYM VR 8750,PARADYM DR8750,ISOLINE 2CT-ISOLINE 2CR

Defibrillator, Implantable, Dual-Chamber

FDA Pre-Market Approval
FDA Class 3 ·ISOLINE 2CR DEFIBRILLATION LEADS MODELS 2CR5, 2CR6 AND 2CR7

Permanent Defibrillator Electrodes

FDA Pre-Market Approval
FDA Class 3 ·LINOX SMART SD, LINOX SMART TD, LINOX SMART S, LINOX SMART T, LINOX SMART S DX, VIGILA 1CR, VOLTA 1CR, KAINOX VCS,PROTEG

Rt-Pcr Multigene Expression Test, Sentinel Lymph Node, Cancer Metastasis Detection

FDA Pre-Market Approval
FDA Class 3 ·GENESEARCH BREAST LYMPH NODE ASSAY

Rt-Pcr Multigene Expression Test, Sentinel Lymph Node, Cancer Metastasis Detection

FDA Pre-Market Approval
FDA Class 3 ·GENESEARCH BREAST LYMPH NODE

Rt-Pcr Multigene Expression Test, Sentinel Lymph Node, Cancer Metastasis Detection

FDA Pre-Market Approval
FDA Class 3 ·GENESEARCH BREAST LYMPH NODE (BLN) ASSAY

Rt-Pcr Multigene Expression Test, Sentinel Lymph Node, Cancer Metastasis Detection

FDA Pre-Market Approval
FDA Class 3 ·GENESEARCH BREAST LYMPH NODE(BLN) ASSAY

Implant, Resorbable, For Articular Osteochondral Repair

FDA Pre-Market Approval
FDA Class 3 ·Agili-C

Imager, Breast, Electrical Impedance

FDA Pre-Market Approval
FDA Class 3 ·T-SCAN 2000

Intraocular Lens

FDA Pre-Market Approval
FDA Class 3 ·TECNIS TORIC 1-PIECE INTRAOCULAR LENSES (IOLS) EXTENDED CYLINDER RANGE (ECR), MODELS ZCT450, ZCT525 AND ZCT600

Imager, Breast, Electrical Impedance

FDA Pre-Market Approval
FDA Class 3 ·TS2000

Heart-Valve, Non-Allograft Tissue

FDA Pre-Market Approval
FDA Class 3 ·Solo Smart Stentless Heart Valve