987 results · 17ms · Sources: EU EUDAMED, US FDA

Automated External Defibrillators (Non-Wearable)

FDA Pre-Market Approval
FDA Class 3 ·Pedi-padz Multifunction Electrodes, Pro-padz Cardiology W/LVP Gel Electrodes, Pro-padz Radiolucent Liquid Gel Electrodes

Implant, Dermal, For Aesthetic Use

FDA Pre-Market Approval
FDA Class 3 ·Juvéderm Voluma XC, Juvéderm Vollure XC, Juvéderm Volbella XC

Automated External Defibrillators (Non-Wearable)

FDA Pre-Market Approval
FDA Class 3 ·Zoll R series OneStep CPR Cable, R Series Onestep Pacing Cable, R Series MFC (Multi-Function Cable), Multifunction Thera

Coronary Drug-Eluting Stent

FDA Pre-Market Approval
FDA Class 3 ·FLEXTOME CUTTING BALLOON

Coronary Drug-Eluting Stent

FDA Pre-Market Approval
FDA Class 3 ·TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM

Acid, Hyaluronic, Intraarticular

FDA Pre-Market Approval
FDA Class 3 ·Gel-One

Wearable Automated External Defibrillator

FDA Pre-Market Approval
FDA Class 3 ·LifeVest Wearable Defibrillator

Acid, Hyaluronic, Intraarticular

FDA Pre-Market Approval
FDA Class 3 ·Gel-Syn™

Stent, Coronary

FDA Pre-Market Approval
FDA Class 3 ·VERIFLEX (LIBERTE) BARE METAL CORONARY STENT SYSTEM

Stent, Renal

FDA Pre-Market Approval
FDA Class 3 ·EXPRESS SD RENAL MONORAIL PREMOUNTED STENT SYSTEM

Stent, Coronary

FDA Pre-Market Approval
FDA Class 3 ·EXPRESS2 CORONARY STENT SYSTEM

Implant, Dermal, For Aesthetic Use

FDA Pre-Market Approval
FDA Class 3 ·RESTYLANE INJECTABLE GEL

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval
FDA Class 3 ·MEDTRONIC GEM MODEL 7227CX, GEM III DR MODEL 7275, GEM III VR MODEL 7231 AND GEM III AT MODEL 7276

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval
FDA Class 3 ·MEDTRONIC. GEM MODEL 7227CX, GEM III DR MODEL 7275, GEM III VR MODEL 7231 AND GEM III AT MODEL 7276

Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled

FDA Pre-Market Approval
FDA Class 3 ·MENTOR MEMORY GEL SILICONE GEL-FILLED BREAST IMPLANTS

Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled

FDA Pre-Market Approval
FDA Class 3 ·MemoryGel® Ultra High Profile - Extended Range (UH-R) Breast Implants

Acid, Hyaluronic, Intraarticular

FDA Pre-Market Approval
FDA Class 3 ·Gel-One

Acid, Hyaluronic, Intraarticular

FDA Pre-Market Approval
FDA Class 3 ·Gel-One

Coronary Drug-Eluting Stent

FDA Pre-Market Approval
FDA Class 3 ·XIENCE Alpine Everolimus Eluting Coronary Stent System, XIENCE Sierra Everolimus Eluting Coronary Stent System, XIENCE S

Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled

FDA Pre-Market Approval
FDA Class 3 ·NATRELLE SILICONE-FILLED BREAST IMPLANTS