1,575 results
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18ms
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Sources: EU EUDAMED, US FDA
Filters
Classification: FDA Class 3
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Next Generation Sequencing Oncology Panel, Somatic Or Germline Variant Detection System
FDA Pre-Market Approval
FDA Class 3
·FoundationOne CDx (F1CDx)
Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D)
FDA Pre-Market Approval
FDA Class 3
·CONTAK CD (MODEL 1823), CONTAK CD 2 (MODELS H115 AND H119), RENEWAL (MODEL H135), RENEWAL 3 (MODELS H170, H175, H177, A
Acid, Hyaluronic, Intraarticular
FDA Pre-Market Approval
FDA Class 3
·ORTHOVISC SODIUM HYALURONATE
Next Generation Sequencing Oncology Panel, Somatic Or Germline Variant Detection System
FDA Pre-Market Approval
FDA Class 3
·FoundationOne CDx
Device, Hemostasis, Vascular
FDA Pre-Market Approval
FDA Class 3
·CLOSER VASCULAR SEALING SYSTEM
Stimulator, Electrical, Implantable, For Incontinence
FDA Pre-Market Approval
FDA Class 3
·INTERSTIM THERAPY FOR URINARY CONTROL
Device, Impotence, Mechanical/Hydraulic
FDA Pre-Market Approval
FDA Class 3
·ALPHA I INFLATABLE PENILE PROSTHESIS
Stimulator, Electrical, Implantable, For Incontinence
FDA Pre-Market Approval
FDA Class 3
·INTERSTIM SACRAL NERVE STIMULATION SYSTEM
Stimulator, Autonomic Nerve, Implanted (Depression)
FDA Pre-Market Approval
FDA Class 3
·VNS THERAPY SYSTEM
Intraocular Lens
FDA Pre-Market Approval
FDA Class 3
·MODEL 809A POSTERIOR CHAMBER INTRAOCULAR LENS
Device, Hemostasis, Vascular
FDA Pre-Market Approval
FDA Class 3
·VASCULAR SOLUTIONS DUETT SEALING DEVICE
Implantable Pacemaker Pulse-Generator
FDA Pre-Market Approval
FDA Class 3
·PHILOS II DR, PHILOS II D, PHILOS II DR-T, PHILOS II SLR, PHILOS II SR, PHILOS II S, AND PROGRAMMER SOFTWARE VERSION A-U
Lenses, Soft Contact, Extended Wear
FDA Pre-Market Approval
FDA Class 3
·AIR OPTIX NIGHT & DAY AQUA (LOTRAFILCON A) SOFT CONTACT LENSES
Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D)
FDA Pre-Market Approval
FDA Class 3
·EPIC AND ATLAS+ HF CRT-D SYSTEMS
Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D)
FDA Pre-Market Approval
FDA Class 3
·CONTAK CD (MODEL 1823), CONTAK CD2 (MODEL H115, H119), RENEWAL (MODELS H135) AND RENEWAL 3 (MODELS H170,H175,H177,H179)
Device, Hemostasis, Vascular
FDA Pre-Market Approval
FDA Class 3
·VASCADE MVP Venous Vascular Closure System (VVCS)
Wearable Automated External Defibrillator
FDA Pre-Market Approval
FDA Class 3
·WEARABLE CARDIOVERTER DEFIBRILLATOR (WCD) 4000 LIFEVEST
Next Generation Sequencing Oncology Panel, Somatic Or Germline Variant Detection System
FDA Pre-Market Approval
FDA Class 3
·Oncomine Dx Target Test
Osseoanchored Prostheses For The Rehabilitation Of Transfemoral Amputees
FDA Pre-Market Approval
FDA Class 3
·OPRA Implant System
Device, Hemostasis, Vascular
FDA Pre-Market Approval
FDA Class 3
·PERCLOSE A-T MONOFILAMENT 6 FR. SUTURE MEDIATED CLOSURE (SMC) SYSTEM