122 results · 20ms · Sources: EU EUDAMED, US FDA

Catheter, Coronary, Atherectomy

FDA Pre-Market Approval
FDA Class 3 ·ANGIOJET RHEOLYTIC THROMBECTOMY SYSTEM

Catheter, Coronary, Atherectomy

FDA Pre-Market Approval
FDA Class 3 ·ANGIOJET RHEOLYTIC THROMBECTOMY CATHETER SYSTEM

Intraocular Lens

FDA Pre-Market Approval
FDA Class 3 ·TECNIS Simplicity Delivery System

Ventricular (Assist) Bypass

FDA Pre-Market Approval
FDA Class 3 ·HEARTWARE LEFT VENTRICULAR ASSIST SYSTEM

Intraocular Lens

FDA Pre-Market Approval
FDA Class 3 ·TECNIS Simplicity Delivery System

Ventricular (Assist) Bypass

FDA Pre-Market Approval
FDA Class 3 ·ABIOMED(R) BVS 5000 BI-VENTRICULAR SUPPORT SYSTEM

Device, Impotence, Mechanical/Hydraulic

FDA Pre-Market Approval
FDA Class 3 ·TITAN INFLATABLE PENILE PROSTHESIS

Sealant, Dural

FDA Pre-Market Approval
FDA Class 3 ·Adherus AutoSpray Dural Sealant, NUS-106

Sealant, Dural

FDA Pre-Market Approval
FDA Class 3 ·Adherus ET AutoSpray Dural Sealant, NUS-109

Aortic Valve, Prosthesis, Percutaneously Delivered

FDA Pre-Market Approval
FDA Class 3 ·Medtronic CoreValve Evolut R XL system

Automated External Defibrillators (Non-Wearable)

FDA Pre-Market Approval
FDA Class 3 ·LIFEPAK 15 monitor/defibrillator

Intraocular Lens

FDA Pre-Market Approval
FDA Class 3 ·TECNIS iTEC Preloaded Delivery System

Agent, Absorbable Hemostatic, Non-Collagen Based

FDA Pre-Market Approval
FDA Class 3 ·SURGICEL Nu-Knit Absorbable Hemostat

Agent, Absorbable Hemostatic, Non-Collagen Based

FDA Pre-Market Approval
FDA Class 3 ·SURGICEL NU-KNIT Absorbable Hemostat

Agent, Absorbable Hemostatic, Non-Collagen Based

FDA Pre-Market Approval
FDA Class 3 ·Surgicel Nu-Knit Absorbable Hemostat

Agent, Absorbable Hemostatic, Non-Collagen Based

FDA Pre-Market Approval
FDA Class 3 ·SURGICEL*/SURGICEL NU-KNIT* ABSORBABLE HEMOSTAT

Agent, Absorbable Hemostatic, Non-Collagen Based

FDA Pre-Market Approval
FDA Class 3 ·SURGICEL*/SURGICEL NU-KNIT* ABSORBABLE HEMOSTAT

Prosthesis, Intervertebral Disc

FDA Pre-Market Approval
FDA Class 3 ·NU VASIVE PCM CERVICAL DISC SYSTEM

Agent, Absorbable Hemostatic, Non-Collagen Based

FDA Pre-Market Approval
FDA Class 3 ·SURGICEL*/SURGICEL NU-KNIT* ABSORBABLE HEMOSTAT

Lens, Contact, Orthokeratology, Overnight

FDA Pre-Market Approval
FDA Class 3 ·Euclid Systems Orthokeratology (oprifocon A) Contact Lenses for Overnight Wear and Euclid Systems Orthokeratology (tisil