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

Implant, Dermal, For Aesthetic Use

FDA Pre-Market Approval
FDA Class 3 ·FIBREL

Replacement Heart-Valve

FDA Pre-Market Approval
FDA Class 3 ·CARPENTIER-EDWARDS S.A.V. BIOPROSTHESIS, MODEL 2650 (AORTIC)

System, Endovascular Graft, Aortic Aneurysm Treatment

FDA Pre-Market Approval
FDA Class 3 ·TALENT THORACIC STENT GRAFT SYSTEM

Implant, Corneal, Refractive

FDA Pre-Market Approval
FDA Class 3 ·KAMRA INLAY

Stent, Carotid

FDA Pre-Market Approval
FDA Class 3 ·EXPONENT SELF-EXPANDING CAROTID STENT SYSTEM WITH OVER-THE-WIRE OR RAPID-EXCHANGE DELIVERY SYSTEM

Chromogenic In Situ Hybridization, Nucleic Acid Amplification, Her2/Neu Gene, Breast Cancer

FDA Pre-Market Approval
FDA Class 3 ·INFORM HER2 DUAL ISH DNA PROBE COCKTAIL

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval
FDA Class 3 ·SOFTCON (VIFILCON A) SOFT CONTACT EXT WEAR LENS

System, Laser, Photodynamic Therapy

FDA Pre-Market Approval
FDA Class 3 ·COHERENT PDL1 AND PDL2 LAMBDA PLUS PHOTODYNAMIC LASERS

Coronary Drug-Eluting Stent

FDA Pre-Market Approval
FDA Class 3 ·XIENCE AND PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEMS

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval
FDA Class 3 ·SAULFON PW-70 A&B

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval
FDA Class 3 ·AUTIMA(TM) MODEL 2251 & MODEL 2600

Oximeter, Fetal Pulse

FDA Pre-Market Approval
FDA Class 3 ·COROMETRICS 120F SERIES MATERNAL/FETAL MONITOR

Stent, Coronary

FDA Pre-Market Approval
FDA Class 3 ·MAGIC WALLSTENT ENDOPROTHESIS

Stent, Coronary

FDA Pre-Market Approval
FDA Class 3 ·BIODIVYSIO AS PS (PHOSPHORYLCHOLINE)COATED STENT DELIVERY SYSTEM

Inhibitor, Peridural Fibrosis (Adhesion Barrier)

FDA Pre-Market Approval
FDA Class 3 ·ADCON-L ANTI-ADHESION CONTROL IN A BARRIER GEL

Generator, Shock-Wave, For Pain Relief

FDA Pre-Market Approval
FDA Class 3 ·DORNIER EPOS ULTRA

Intraocular Lens

FDA Pre-Market Approval
FDA Class 3 ·MODEL AC (AC1-AC5)

System, Endovascular Graft, Arteriovenous (Av) Dialysis Access Circuit Stenosis Treatment

FDA Pre-Market Approval
FDA Class 3 ·FLAIR ENDOVASCULAR STENT GRAFT

Ventricular (Assist) Bypass

FDA Pre-Market Approval
FDA Class 3 ·THORATEC(R) VENTRICULAR ASSIST DEVICE (VAD) SYSTEM

System, Endovascular Graft, Aortic Aneurysm Treatment

FDA Pre-Market Approval
FDA Class 3 ·THE TALENT ABDOMINAL STENT GRAFT SYSTEM