4,992 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Classification: FDA Class 3
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Intraocular Lens
FDA Pre-Market Approval
FDA Class 3
·MODELS B-13F (P-10) & B-1H (P-11)
Implantable Pulse Generator, Pacemaker (Non-Crt)
FDA Pre-Market Approval
FDA Class 3
·VITALITY DS ICD SYSTEMS
Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter
FDA Pre-Market Approval
FDA Class 3
·BLAZER OPEN-IRRIGATED ABLATION CATHETER
Implantable Cardioverter Defibrillator (Non-Crt)
FDA Pre-Market Approval
FDA Class 3
·RELIANCE 4-SITE
Implantable Pulse Generator, Pacemaker (Non-Crt)
FDA Pre-Market Approval
FDA Class 3
·TELIGEN/INCEPTA/ENERGEN/PUNCTUA IMPLANTABLE CARDIOVERTER DEFIBRILLATORS
Implantable Cardioverter Defibrillator (Non-Crt)
FDA Pre-Market Approval
FDA Class 3
·RELIANCE IS-4 DEFIBRILLATION LEAD
Cardiac Ablation Percutaneous Catheter
FDA Pre-Market Approval
FDA Class 3
·BLAZER II XP CARDIAC ABLATION CATHETER/CABLE/BLAZER II HIGH TORQUE DISTAL (HTD) ABLATION CATHETER/CABLE/BLAZER PRIME
Implantable Pulse Generator, Pacemaker (Non-Crt)
FDA Pre-Market Approval
FDA Class 3
·SUTURE SLEEVE ACCESSORY
Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D)
FDA Pre-Market Approval
FDA Class 3
·NG3 CARDIAC RESYNCHRONIZATION THERAPY-DEFIBRILLATOR (CRT-D). DYNAGEN CRT-D, X4 CRT-D; INOGEN CRT-D, X4 CRT-D; ORIGEN CRT
Intraocular Lens
FDA Pre-Market Approval
FDA Class 3
·LENSTEC SOFTEC HD POSTERIOR CHAMBER INTRAOCULAR LENS
Implantable Pulse Generator, Pacemaker (Non-Crt)
FDA Pre-Market Approval
FDA Class 3
·INGENIO MRI, VITALIO MRI, FORMIO MRI, ESSENTIO MRI, ACCOLADE MRI, PROPONENT MRI
Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D)
FDA Pre-Market Approval
FDA Class 3
·CONTAK CD,EASYTRAK, LIVIAN, COGNIS AND ACUITY SPIRIAL AUTOMATIC IMPLANTABLE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLL
Implantable Cardioverter Defibrillator (Non-Crt)
FDA Pre-Market Approval
FDA Class 3
·Dynagen Models: D020, D021, D022, D023; D150, D151, D152, D153; Inogen Models: D010, D011, D012, D013, D140, D141, D14
Implantable Cardioverter Defibrillator (Non-Crt)
FDA Pre-Market Approval
FDA Class 3
·RES-Q and RES-Q MICRON ICD and ICD Lead Family
Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D)
FDA Pre-Market Approval
FDA Class 3
·Latitude NXT Patient Management System (COGNIS, ENERGEN, PUNCTUA, INCEPTA, ORIGEN, INOGEN, DYNAGEN, AUTOGEN, RESONATE,
Excimer Laser System
FDA Pre-Market Approval
FDA Class 3
·LADARVISION 4000 EXCIMER LASER SYSTEM
Implantable Pulse Generator, Pacemaker (Non-Crt)
FDA Pre-Market Approval
FDA Class 3
·L110 ESSENTIO MRI SR, L111 ESSENTIO MRI DR, L131 ESSENTIO MRI EL DR, L210 PROPONENT, L211 PROPONENT, L231 PROPONENT,
Occluder, Patent Ductus, Arteriosus
FDA Pre-Market Approval
FDA Class 3
·AMPLATZER SEPTAL OCCLUDER (ASO) DEVICE
Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation
FDA Pre-Market Approval
FDA Class 3
·POLARx and POLARxFIT Cryoablation Catheters
Intraocular Lens
FDA Pre-Market Approval
FDA Class 3
·ANTERIOR CHAMBER INTRAOCULAR LENS