145 results · 31ms · Sources: EU EUDAMED, US FDA

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