10,000 results · 35ms · Sources: EU EUDAMED, US FDA

Intraocular Lens

FDA Pre-Market Approval
FDA Class 3 ·SOFLEX UV-ABSORBING SILICONE POSTERIOR CHAMBER INTRAOCULAR LENS MODELS L15IU AND L16IU

Intraocular Pressure Lowering Implant

FDA Pre-Market Approval
FDA Class 3 ·AQUAFLOW COLLAGEN GLAUCOMA DRAINAGE DEVICES

Implant, Hearing, Active, Middle Ear, Partially Implanted

FDA Pre-Market Approval
FDA Class 3 ·VIBRANT SOUNDBRIDGE SYSTEM

Biologic Material, Dental

FDA Pre-Market Approval
FDA Class 3 ·EMODOGAIN

Agent, Absorbable Hemostatic, Non-Collagen Based

FDA Pre-Market Approval
FDA Class 3 ·OXYCEL OXIDIZED

Heart-Valve, Non-Allograft Tissue

FDA Pre-Market Approval
FDA Class 3 ·TRIFECTA VALVE

Implant, Cochlear

FDA Pre-Market Approval
FDA Class 3 ·NUCLES 22 CHANNEL COCHLEAR IMPLANT SYSTEM FOR CHIL

Ventilator, High Frequency

FDA Pre-Market Approval
FDA Class 3 ·HIGH FREQUENCY VENTILATOR

Implant, Dermal, For Aesthetic Use

FDA Pre-Market Approval
FDA Class 3 ·HYDRELLE

Catheter, Coronary, Atherectomy

FDA Pre-Market Approval
FDA Class 3 ·ANGIOJET ULTRA THROMBECTOMY SYSTEM CONSOLE

Catheter, Coronary, Atherectomy

FDA Pre-Market Approval
FDA Class 3 ·ROTABLATOR(R)

Absorbable Collagen Hemostatic Agent With Thrombin

FDA Pre-Market Approval
FDA Class 3 ·FLOSEAL MATRIX HEMOSTATIC SEALANT

Implant, Dermal, For Aesthetic Use

FDA Pre-Market Approval
FDA Class 3 ·RADIESSE 1.5CC AND 0.3CC

Implant, Intragastric For Morbid Obesity

FDA Pre-Market Approval
FDA Class 3 ·GARREN GASTRIC BUBBLE

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 ·CYBERLITH IV UNIPOLAR PULSE GENERATOR

Stent, Superficial Femoral Artery

FDA Pre-Market Approval
FDA Class 3 ·COMPLETE SE VASCULAR STENT SYSTEM

Agent, Absorbable Hemostatic, Non-Collagen Based

FDA Pre-Market Approval
FDA Class 3 ·Arista AH Absorbable Hemostatic

Filler, Recombinant Human Bone Morphogenetic Protein, Collagen Scaffold With Metal Prosthesis, Osteoinduction

FDA Pre-Market Approval
FDA Class 3 ·Infuse Bone Graft/Medtronic Interbody Fusion Device

Coronary Drug-Eluting Stent

FDA Pre-Market Approval
FDA Class 3 ·XIENCE PRIME/LL, XPEDITION, XPEDITION SV,LL, AND ALPINE EVEROLIMUS ELUTING CORONARY STENT SYSTEM