10,000 results
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24ms
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Sources: EU EUDAMED, US FDA
Filters
Classification: FDA Class 3
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Cardiac Ablation Percutaneous Catheter
FDA Pre-Market Approval
FDA Class 3
·CHILLI II COOLED ABLATION CATHETER AND CABLE
Lenses, Soft Contact, Extended Wear
FDA Pre-Market Approval
FDA Class 3
·BIOFINITY XR TORIC
Device. Laser Peripheral Angioplasty
FDA Pre-Market Approval
FDA Class 3
·TRIMEDYNE'S LASERPROBE-PLR{TM} CATHETER & OPTILASE
Sealant, Polymerizing
FDA Pre-Market Approval
FDA Class 3
·Progel Pleural Air Leak Sealant (Progel PALS)
Ventricular (Assist) Bypass
FDA Pre-Market Approval
FDA Class 3
·HeartMate II Left Ventricular Assist System
Heart-Valve, Non-Allograft Tissue
FDA Pre-Market Approval
FDA Class 3
·HANCOCK I LOW POROSITY & MODIFIED ORIFICE VALVED CONDUIT
Agent, Bulking, Injectable For Gastro-Urology Use
FDA Pre-Market Approval
FDA Class 3
·DEFLUX SYRINGE
Aid, Surgical, Viscoelastic
FDA Pre-Market Approval
FDA Class 3
·Amvisc and Amvisc Plus Ophthalmic Viscosurgical Device (OVD)
Agent, Absorbable Hemostatic, Collagen Based
FDA Pre-Market Approval
FDA Class 3
·SUPERSTAT
Intraocular Lens
FDA Pre-Market Approval
FDA Class 3
·STAAR SURGICAL ELASTIC/ELASTIMIDE & ELASTIC TORIC ULTRAVIOLET ABSORBING POSTERIOR CHAMBER INTRAOCULAR LENSES
Replacement Heart-Valve
FDA Pre-Market Approval
FDA Class 3
·CARPENTIER-EDWARDS PERIMOUNT PERICARDIAL AORTIC BIOPROSTHESIS, CARPENTIER-EDWARDS PERIMOUNT THEON PERICARDIAL AORTIC BIO
Automated Insulin Dosing , Threshold Suspend
FDA Pre-Market Approval
FDA Class 3
·ENLITE SENSOR
System, Laser, Transmyocardial Revascularization
FDA Pre-Market Approval
FDA Class 3
·CARDIOGENESIS TMR SYSTEM
Prosthesis, Breast, Inflatable, Internal, Saline
FDA Pre-Market Approval
FDA Class 3
·SALINE-FILLED BREAST IMPLANTS
Ventricular (Assist) Bypass
FDA Pre-Market Approval
FDA Class 3
·HeartMate 3 Left Ventricular Assist System
Implantable Pulse Generator, Pacemaker (Non-Crt)
FDA Pre-Market Approval
FDA Class 3
·CADENCE FAMILY OF ICDS
Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D)
FDA Pre-Market Approval
FDA Class 3
·MERLIN PATIENT CARE SYSTEM MODEL 3650
Agent, Injectable, Embolic
FDA Pre-Market Approval
FDA Class 3
·Apollo Onyx Delivery Microcatheter
Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter
FDA Pre-Market Approval
FDA Class 3
·Therapy Cool Path, Safire BLU, Safire BLU SP, and Therapy Cool Path SP Ablation Catheters
Implant, Intragastric For Morbid Obesity
FDA Pre-Market Approval
FDA Class 3
·LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM