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

Catheter, Coronary, Atherectomy

FDA Pre-Market Approval
FDA Class 3 ·SIMPSON CORONARY ATHEROCATH-GTO

Lens, Multifocal Intraocular

FDA Pre-Market Approval
FDA Class 3 ·AcrySof ReSTOR Posterior Chamber Intraocular Lenses

Absorbable Coronary Drug-Eluting Stent

FDA Pre-Market Approval
FDA Class 3 ·ABSORB GT1 BIORESORBABLE VASCULAR SCAFFOLD (BVS) SYSTEM

Intraocular Lens

FDA Pre-Market Approval
FDA Class 3 ·Clareon Aspheric Hydrophobic Acrylic Intraocular Lens (with the AutonoMe Pre-Loaded Delivery System) Claeron Toric Asphe

Intraocular Lens

FDA Pre-Market Approval
FDA Class 3 ·AcrySof Posterior Chamber Intraocular Lens

Absorbable Coronary Drug-Eluting Stent

FDA Pre-Market Approval
FDA Class 3 ·ABSORB GT1 BIORESORBABLE VASCULAR SCAFFOLD (BVS) SYSTEM

Absorbable Coronary Drug-Eluting Stent

FDA Pre-Market Approval
FDA Class 3 ·ABSORB GT1 BIORESORBABLE VASCULAR SCAFFOLD (BVS) SYSTEM

Absorbable Coronary Drug-Eluting Stent

FDA Pre-Market Approval
FDA Class 3 ·Absorb GTi Bioresorbable Vascular Scaffold (BVS) System

Absorbable Coronary Drug-Eluting Stent

FDA Pre-Market Approval
FDA Class 3 ·Absorb GT1 Bioresorbable Vascular Scaffold (BVS) System

Catheter, Coronary, Atherectomy

FDA Pre-Market Approval
FDA Class 3 ·SIMPSON CORONARY ATHEROCATH(R) (GTO)(TM) DEVICE

Absorbable Coronary Drug-Eluting Stent

FDA Pre-Market Approval
FDA Class 3 ·ABSORB GT1 BIORESORBABLE VASCULAR SCAFFOLD (BVS) SYSTEM

Absorbable Coronary Drug-Eluting Stent

FDA Pre-Market Approval
FDA Class 3 ·Absorb GT1 Bioresorbable Vascular Scaffold (BVS) System.

Absorbable Coronary Drug-Eluting Stent

FDA Pre-Market Approval
FDA Class 3 ·ABSORB GT1 BIORESORBABLE VASCULAR SCAFFOLD (BVS) SYSTEM

Absorbable Coronary Drug-Eluting Stent

FDA Pre-Market Approval
FDA Class 3 ·Absorb GT1 Bioresorbable Vascular Scaffold (BVS) System

Absorbable Coronary Drug-Eluting Stent

FDA Pre-Market Approval
FDA Class 3 ·ABSORB GT1 BIORESORBABLE VASCULAR SCAFFOLD (BVS) SYSTEM

Catheter, Coronary, Atherectomy

FDA Pre-Market Approval
FDA Class 3 ·SIMPSON CORONARY ATHEROCATH-SCA-EX, GTO AND BANTAM ATHERECTOMY CATHETERS

Automated External Defibrillators (Non-Wearable)

FDA Pre-Market Approval
FDA Class 3 ·TZ Medical Defibrillation Electrodes, Accessory Cables, and Connectors

Stent, Superficial Femoral Artery

FDA Pre-Market Approval
FDA Class 3 ·BioMimics 3D Vascular Stent System

Catheter, Coronary, Atherectomy

FDA Pre-Market Approval
FDA Class 3 ·SIMPSON CORONARY ATHEROCATH(TM),SCA-EX(TM), SCA-EX 7 FRENCH GRAFT AND ATHEROCATH-GTO(R)

System, Photopheresis, Extracorporeal

FDA Pre-Market Approval
FDA Class 3 ·Therakos Cellex Photopheresis System