145 results
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31ms
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Sources: EU EUDAMED, US FDA
Filters
Classification: FDA Class 3
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Lens, Multifocal Intraocular
FDA Pre-Market Approval
FDA Class 3
·AMO ARRAY MULTIFOCAL UV-ABSORBING SILCONE POSTERIOR CHAMBER INTRAOCULAR LENS
Agent, Absorbable Hemostatic, Collagen Based
FDA Pre-Market Approval
FDA Class 3
·COLLASTAT ABSORBABLE COLLAGEN HEMOSTATIC AGENTS
Agent, Absorbable Hemostatic, Collagen Based
FDA Pre-Market Approval
FDA Class 3
·HELISTAT ABSORBABLE COLLAGEN HEMOSTATIC AGENTS
Material, Dressing, Surgical, Polylactic Acid
FDA Pre-Market Approval
FDA Class 3
·COLLACOTE ABSORBABLE COLLAGEN WOUND DRESSING
Intraocular Lens
FDA Pre-Market Approval
FDA Class 3
·MODELS AC-21/AC-21B ANTERIOR CHAMBER IOL
Intraocular Lens
FDA Pre-Market Approval
FDA Class 3
·MODES SI-18B AND SI-18NB ULTRAVIOLET ABSORBINGSILICONE POSTERIOR CHAMBER IOLS
Intraocular Lens
FDA Pre-Market Approval
FDA Class 3
·MODELS PC-58NBM & PC-58NBZ IOLS
Intraocular Lens
FDA Pre-Market Approval
FDA Class 3
·MODEL PC-28LB POSTERIOR CHAMBER INTRAOCULAR LENS
Stent, Renal
FDA Pre-Market Approval
FDA Class 3
·EXPRESS SD RENAL MONORAIL PREMOUNTED STENT SYSTEM
Laparoscopic Contraceptive Tubal Occlusion Device
FDA Pre-Market Approval
FDA Class 3
·Falope Ring Bands
Aortic Valve, Prosthesis, Percutaneously Delivered
FDA Pre-Market Approval
FDA Class 3
·Edwards SAPIEN 3 Ultra RESILIA Transcatheter Heart Valve
Heart-Valve, Non-Allograft Tissue
FDA Pre-Market Approval
FDA Class 3
·INSPIRIS RESILIA Aortic Valve, KONECT RESILIA Aortic Valve Conduit (AVC), MITRIS RESILIA Mitral Valve
Catheter, Coronary, Atherectomy
FDA Pre-Market Approval
FDA Class 3
·ROTAWIRE GUIDE WIRE, A COMPONENT OF THE ROTABLATOR ROTATIONAL ANGIOPLASTY SYSTEM
Paste, Injectable For Vocal Cord Augmentation
FDA Pre-Market Approval
FDA Class 3
·POLYTEF PASTE FOR INJECTION
Stimulator, Hypoglossal Nerve, Implanted, Apnea
FDA Pre-Market Approval
FDA Class 3
·Inspire II Upper Airway Stimulator
Programmer, Pacemaker
FDA Pre-Market Approval
FDA Class 3
·V1. 2A PROGRAMMER SOFTWARE
Programmer, Pacemaker
FDA Pre-Market Approval
FDA Class 3
·V.1 2A PROGRAMMER SOFTWARE
Permanent Pacemaker Electrode
FDA Pre-Market Approval
FDA Class 3
·TENDRILL PASSIVE PLUS/AU PLUS DX
Implantable Cardioverter Defibrillator (Non-Crt)
FDA Pre-Market Approval
FDA Class 3
·VENTRITEX TUL LEAD SYSTEM
Implantable Cardioverter Defibrillator (Non-Crt)
FDA Pre-Market Approval
FDA Class 3
·CADENCE TIERED THERAPY DEFIBRILLATOR SYSTEM