673 results · 18ms · Sources: EU EUDAMED, US FDA

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