1,591 results · 18ms · Sources: EU EUDAMED, US FDA

Wearable Automated External Defibrillator

FDA Pre-Market Approval
FDA Class 3 ·LIFEVEST WEARABLE DEFIBRILLATOR

Device, Hemostasis, Vascular

FDA Pre-Market Approval
FDA Class 3 ·CLOSER/CLOSER S SMC 6 FRENCH SYSTEMS

Device, Hemostasis, Vascular

FDA Pre-Market Approval
FDA Class 3 ·X-PRESS 6 FRENCH VASCULAR CLOSURE SYSTEM

Device, Hemostasis, Vascular

FDA Pre-Market Approval
FDA Class 3 ·STARCLOSE VASCULAR CLOSURE SYSTEM

Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P)

FDA Pre-Market Approval
FDA Class 3 ·CONTAK RENEWAL MODELS H125 AND H120 WITH THE MODEL 2865 VERSION 1.8 APPLICATION SOFTWARE

System, Imaging, Fluorescence

FDA Pre-Market Approval
FDA Class 3 ·KARL STORZ AUTOFLUORESCENCE SYSTEM

Acid, Hyaluronic, Intraarticular

FDA Pre-Market Approval
FDA Class 3 ·SYNVISC-ONE

Acid, Hyaluronic, Intraarticular

FDA Pre-Market Approval
FDA Class 3 ·SINOVIAL (SODIUM HYALURONATE 0.8%)

Device, Thermal Ablation, Endometrial

FDA Pre-Market Approval
FDA Class 3 ·NOVASURE IMPENDANCE CONTROLLED ENDOMETRIAL ABLATION SYSTEM

Acid, Hyaluronic, Intraarticular

FDA Pre-Market Approval
FDA Class 3 ·HYMOVIS

Cancer-Related Germline Gene Mutation Detection System

FDA Pre-Market Approval
FDA Class 3 ·BRACAnalysis CDx

Acid, Hyaluronic, Intraarticular

FDA Pre-Market Approval
FDA Class 3 ·SYNOJOYNT

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

FDA Pre-Market Approval
FDA Class 3 ·FoundationOne CDx (F1CDx)

Implanted Fecal Incontinence Device

FDA Pre-Market Approval
FDA Class 3 ·AMS ACTICON NEOSPHINCTER

Pump, Infusion, Implanted, Programmable

FDA Pre-Market Approval
FDA Class 3 ·INFUSAID IMPLANTABLE INFUSION PUMP MODEL-100,200,4

Acid, Hyaluronic, Intraarticular

FDA Pre-Market Approval
FDA Class 3 ·TRILURON

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

FDA Pre-Market Approval
FDA Class 3 ·Oncomine™ Dx Target Test

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval
FDA Class 3 ·MEDTRONIC MODEL 7276 GEM III AT IMPLANTABLE DEFIBRILLATOR

Acid, Hyaluronic, Intraarticular

FDA Pre-Market Approval
FDA Class 3 ·GENVISC 850

Transvenous Temporary Phrenic Nerve Stimulator

FDA Pre-Market Approval
FDA Class 3 ·AeroPace® System