2,488 results · 17ms · Sources: EU EUDAMED, US FDA

Catheter, Coronary, Atherectomy

FDA Pre-Market Approval
FDA Class 3 ·DIAMONDBACK 360 CORONARY ORBITAL ATHERECTOMY SYSTEM

Implant, Dermal, For Aesthetic Use

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

Implant, Dermal, For Aesthetic Use

FDA Pre-Market Approval
FDA Class 3 ·Juvéderm Ultra, Ultra XC, Juvéderm Ultra XC

Agent, Absorbable Hemostatic, Collagen Based

FDA Pre-Market Approval
FDA Class 3 ·HELITENE ABSORBABLE COLLAGEN HEMOSTATIC AGENTS

Sealant, Dural

FDA Pre-Market Approval
FDA Class 3 ·DURASEAL DURAL SEALANT SYSTEM

Material, Dressing, Surgical, Polylactic Acid

FDA Pre-Market Approval
FDA Class 3 ·CollaCote™, CollaTape®, CollaPlug®, Absorbable Collagen Wound Dressings for Dental Surgery

Device, Thermal Ablation, Endometrial

FDA Pre-Market Approval
FDA Class 3 ·HER OPTION CRYOABLATION THERAPY SYSTEM

Implant, Dermal, For Aesthetic Use

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

Prosthesis, Breast, Inflatable, Internal, Saline

FDA Pre-Market Approval
FDA Class 3 ·NATRELLE Saline-Filled Breast Implants

Fluid, Hysteroscopy

FDA Pre-Market Approval
FDA Class 3 ·HYSKON HYSTEROSCOPY FLUID 32% (W/V) DEXTRAN 70 IN DEXTROSE

Intraocular Lens

FDA Pre-Market Approval
FDA Class 3 ·MODEL 56BUV20-24DO IOL

Prosthesis, Breast, Inflatable, Internal, Saline

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

Drug-Eluting Sinus Stent

FDA Pre-Market Approval
FDA Class 3 ·Propel Sinus Implant & Propel mini Sinus Implant

Sealant, Dural

FDA Pre-Market Approval
FDA Class 3 ·DURASEAL DURAL SEALANT SYSTEM

Sealant, Polymerizing

FDA Pre-Market Approval
FDA Class 3 ·PROGEL™ Pleural Air Leak Sealant

Sensor, Glucose, Invasive

FDA Pre-Market Approval
FDA Class 3 ·DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM

Implant, Dermal, For Aesthetic Use

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

Sealant, Dural

FDA Pre-Market Approval
FDA Class 3 ·DURASEAL EXACT SPINE SEALANT

Agent, Absorbable Hemostatic, Collagen Based

FDA Pre-Market Approval
FDA Class 3 ·COLLASTAT ABSORBABLE COLLAGEN HEMOSTATIC AGENT MICROFIBRILLAR

Agent, Absorbable Hemostatic, Collagen Based

FDA Pre-Market Approval
FDA Class 3 ·Collastat™ Absorbable Collagen Hemostatic Sponge and Collastat™ Absorbable Collagen Hemostatic Agent – Microfibrillar Fo