673 results
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18ms
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Sources: EU EUDAMED, US FDA
Filters
Classification: FDA Class 3
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Heart-Valve, Mechanical
FDA Pre-Market Approval
FDA Class 3
·STARR-EDWARDS SILASTIC BALL HEART VALVE PROSTHESES
Aortic Valve, Prosthesis, Percutaneously Delivered
FDA Pre-Market Approval
FDA Class 3
·LOTUS Edge Valve System
Heart-Valve, Mechanical
FDA Pre-Market Approval
FDA Class 3
·MEDTRONIC(R) HALL PROSTHETIC HEART VALVE
Absorbable Collagen Hemostatic Agent With Thrombin
FDA Pre-Market Approval
FDA Class 3
·VITAGEL SURGICAL HEMOSTAT
Implantable Pulse Generator, Pacemaker (Non-Crt)
FDA Pre-Market Approval
FDA Class 3
·MODEL283 PULSE GENERATOR & MODEL 370/375 SUPPORT S
Kit, Test, Alpha-Fetoprotein For Neural Tube Defects
FDA Pre-Market Approval
FDA Class 3
·ABBOTT AFP-EIA DIAGNOSTIC KIT FOR CANCER
Implanted Fecal Incontinence Device
FDA Pre-Market Approval
FDA Class 3
·AMS ACTICON NEOSPHINCTER
Kit, Assay, Progesterone Receptor
FDA Pre-Market Approval
FDA Class 3
·FLUORO-CEP (R) PROGESTERONE
Instrument, Glucose, Noninvasive Technology
FDA Pre-Market Approval
FDA Class 3
·GLUCOWATCH AUTOMATIC GLUCOSE BIOGRAPHER
Lithotripter, Shockwave (For Treating Gallbladder Stones)
FDA Pre-Market Approval
FDA Class 3
·MEDSTONE STS LITHOTRIPTER
Lenses, Soft Contact, Extended Wear
FDA Pre-Market Approval
FDA Class 3
·SOFT-55 EW APHAKIC, VIFILCON A(SOFT CONTACTS FOR EXTENDED WEAR)
System, Hyperthermia, Rf/Microwave (Benign Prostatic Hyperplasia),Thermotherapy
FDA Pre-Market Approval
FDA Class 3
·DORNIER UROWAVE MICROWAVE THERMOTHERAPY SYSTEM
Intraocular Lens
FDA Pre-Market Approval
FDA Class 3
·MODEL AC10 & AC20 IOLS
Agent, Absorbable Hemostatic, Collagen Based
FDA Pre-Market Approval
FDA Class 3
·HEMOPAD ABSORBABLE COLLAGEN HEMOSTAT
Implant, Dermal, For Aesthetic Use
FDA Pre-Market Approval
FDA Class 3
·HYDRELLE
Intraocular Lens
FDA Pre-Market Approval
FDA Class 3
·MODEL AC-21 OMNIFIT ANTERIOR CHAMBER
Paste, Injectable For Vocal Cord Augmentation
FDA Pre-Market Approval
FDA Class 3
·MENTOR POLYTEF PASTE FOR INJECTION
Device, Angioplasty, Laser, Coronary
FDA Pre-Market Approval
FDA Class 3
·SPECTRAPROBE-PLR MODEL 900 OPTILASE CONTACT LASER
Tissue Graft Of 6mm And Greater
FDA Pre-Market Approval
FDA Class 3
·PROCOL VASCULAR BIOPROSTHESIS
Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter
FDA Pre-Market Approval
FDA Class 3
·CRYOCOR CRYOABLATION SYSTEM