673 results
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18ms
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Sources: EU EUDAMED, US FDA
Filters
Classification: FDA Class 3
×
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