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

Next Generation Sequencing Oncology Panel, Somatic Or Germline Variant Detection System

FDA Pre-Market Approval
FDA Class 3 ·xT CDx

Next Generation Sequencing Oncology Panel, Somatic Or Germline Variant Detection System

FDA Pre-Market Approval
FDA Class 3 ·xT CDx

Next Generation Sequencing Oncology Panel, Somatic Or Germline Variant Detection System

FDA Pre-Market Approval
FDA Class 3 ·xT CDx

Aortic Valve, Prosthesis, Percutaneously Delivered

FDA Pre-Market Approval
FDA Class 3 ·Ascendra+ Delivery System; Balloon Aortic Valvuloplasty Catheter; NovaFlex+ Delivery System; Crimper; Edwards Ballon Cat

Fluid, Intraocular

FDA Pre-Market Approval
FDA Class 3 ·PERFLUORON (PURIFIED PERFLUORO-N-OCTANE LIQUID)

Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval
FDA Class 3 ·Blazer II Cardiac Ablation System

Catheter, Coronary, Atherectomy

FDA Pre-Market Approval
FDA Class 3 ·Rotablator Rotational Angioplasty System Guidewire

Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval
FDA Class 3 ·Chilli II Cooled RF Ablation system

Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter

FDA Pre-Market Approval
FDA Class 3 ·Blazer II XP Cardiac RF Ablation System

Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter

FDA Pre-Market Approval
FDA Class 3 ·Blazer Open Irrigated Cardiac Ablation System

Catheter, Percutaneous Transluminal Coronary Angioplasty (Ptca), Cutting/Scoring

FDA Pre-Market Approval
FDA Class 3 ·Wolverine Coronary Cutting Balloon (Monorail and Over-The-Wire)

Stent, Renal

FDA Pre-Market Approval
FDA Class 3 ·Express SD Monorail Premounted Stent System

Stent, Coronary

FDA Pre-Market Approval
FDA Class 3 ·Rebel Platinum Chromium Coronary Stent System (Monorail and Over-the-Wire)

Coronary Drug-Eluting Stent

FDA Pre-Market Approval
FDA Class 3 ·Promus Premier Everolimus-Eluting Platinum Chromium Coronary Stent System

Light Adjustable Lens (Lal) And Light Delivery Device (Ldd)

FDA Pre-Market Approval
FDA Class 3 ·Light Adjustable Lens (LAL), Light Delivery Device (LDD) System

Light Adjustable Lens (Lal) And Light Delivery Device (Ldd)

FDA Pre-Market Approval
FDA Class 3 ·Light Adjustable Lens, Light Delivery Device

Light Adjustable Lens (Lal) And Light Delivery Device (Ldd)

FDA Pre-Market Approval
FDA Class 3 ·Light Adjustable Lens and Light Delivery Device

Light Adjustable Lens (Lal) And Light Delivery Device (Ldd)

FDA Pre-Market Approval
FDA Class 3 ·LIGHT ADJUSTABLE LENS (LAL) AND LIGHT DELIVERY DEVICE (LDD)

Light Adjustable Lens (Lal) And Light Delivery Device (Ldd)

FDA Pre-Market Approval
FDA Class 3 ·RxSight Light Adjustable Lens and Light Delivery Device

Light Adjustable Lens (Lal) And Light Delivery Device (Ldd)

FDA Pre-Market Approval
FDA Class 3 ·Light Adjustable Lens, Light Delivery Device