760 results · 19ms · Sources: EU EUDAMED, US FDA

Sealant, Dural

FDA Pre-Market Approval
FDA Class 3 ·DuraSeal Exact Spine Sealant System 3mL & 5mL

Aid, Surgical, Viscoelastic

FDA Pre-Market Approval
FDA Class 3 ·PROVISC

Aid, Surgical, Viscoelastic

FDA Pre-Market Approval
FDA Class 3 ·DUOVISC AND DISCOVISC

Implant, Dermal, For Aesthetic Use

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

Lymph Node Location System During Sentinel Biopsy Procedure

FDA Pre-Market Approval
FDA Class 3 ·Magtrace and Sentimag Magnetic Locatization System (PUV)

Acid, Hyaluronic, Intraarticular

FDA Pre-Market Approval
FDA Class 3 ·Orthovisc

Sealant, Dural

FDA Pre-Market Approval
FDA Class 3 ·DuraSeal Exact Spinal Sealant (3mL), DuraSeal Exact Spinal Sealant (5mL)

Ventricular (Assist) Bypass

FDA Pre-Market Approval
FDA Class 3 ·HeartWare Ventricular Assist System

Agent, Bulking, Injectable For Gastro-Urology Use

FDA Pre-Market Approval
FDA Class 3 ·DURASPHERE EXP

Acid, Hyaluronic, Intraarticular

FDA Pre-Market Approval
FDA Class 3 ·Orthovisc

Implant, Dermal, For Aesthetic Use

FDA Pre-Market Approval
FDA Class 3 ·Bellafill Dermal Filler

Implant, Dermal, For Aesthetic Use

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

Implant, Dermal, For Aesthetic Use

FDA Pre-Market Approval
FDA Class 3 ·Juvéderm Injectable Gel Implants

Implant, Dermal, For Aesthetic Use

FDA Pre-Market Approval
FDA Class 3 ·ZYPLAST COLLAGEN IMPLANT ZYDERM I AND II COLLAGEN IMPLANT

Implant, Dermal, For Aesthetic Use

FDA Pre-Market Approval
FDA Class 3 ·JUVEDERM VOLBELLA XC

Kit, Dna Detection, Human Papillomavirus

FDA Pre-Market Approval
FDA Class 3 ·cobas HPV Test

Implant, Dermal, For Aesthetic Use

FDA Pre-Market Approval
FDA Class 3 ·RESTYLANE L AND PERLANE L INJECTABLE GEL

Aid, Surgical, Viscoelastic

FDA Pre-Market Approval
FDA Class 3 ·OCUCOAT OPHTHALMIC VISCOSURGICAL DEVICE

Microspheres Radionuclide

FDA Pre-Market Approval
FDA Class 3 ·SIR-Spheres Y-90 resin microspheres

Agent, Absorbable Hemostatic, Collagen Based

FDA Pre-Market Approval
FDA Class 3 ·COSTASIS(R)/DYNASTAT SURGICAL HEMOSTAT