2,583 results · 18ms · Sources: EU EUDAMED, US FDA

Sealant, Polymerizing

FDA Pre-Market Approval
FDA Class 3 ·NEOMEND'S PROGEL PLEURAL AIR LEAK SEALANT

Sealant, Polymerizing

FDA Pre-Market Approval
FDA Class 3 ·TRIDYNE™ Vascular Sealant

Agent, Absorbable Hemostatic, Collagen Based

FDA Pre-Market Approval
FDA Class 3 ·COLLASTAT INSTAT ABSORABLE COLLAGEN HEMOSTATIC AGENTS

Sealant, Polymerizing

FDA Pre-Market Approval
FDA Class 3 ·PROGEL PLEURAL AIR LEAK SEALANT

Drug-Eluting Sinus Stent

FDA Pre-Market Approval
FDA Class 3 ·Propel Contour Sinus Implant

Prosthesis, Breast, Inflatable, Internal, Saline

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

Device, Thermal Ablation, Endometrial

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

Wearable Automated External Defibrillator

FDA Pre-Market Approval
FDA Class 3 ·LIFEVEST WEARABLE DEFIBRILLATOR

Sealant, Polymerizing

FDA Pre-Market Approval
FDA Class 3 ·Tridyne™ Vascular Sealant

Sealant, Dural

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

Sensor, Glucose, Invasive

FDA Pre-Market Approval
FDA Class 3 ·DEXCOM SEVEN & SEVEN PLUS

Ventilator, High Frequency

FDA Pre-Market Approval
FDA Class 3 ·LifePulse High Frequency Ventilator

Iliac Covered Stent, Arterial

FDA Pre-Market Approval
FDA Class 3 ·iCast Covered Stent System

Sealant, Dural

FDA Pre-Market Approval
FDA Class 3 ·DuraSeal Dural Sealant System.

Agent, Absorbable Hemostatic, Collagen Based

FDA Pre-Market Approval
FDA Class 3 ·Helistat and Helitene Absorbable Collagen Hemostatic Agents

Wearable Automated External Defibrillator

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

Implant, Dermal, For Aesthetic Use

FDA Pre-Market Approval
FDA Class 3 ·Juvederm Voluma XC, Juvederm Vollure XC, and Juvederm Volux XC

Material, Dressing, Surgical, Polylactic Acid

FDA Pre-Market Approval
FDA Class 3 ·COLLAPLUG ABSORBABLE COLLAGEN WOUND DRESSING

Wearable Automated External Defibrillator

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

Agent, Absorbable Hemostatic, Collagen Based

FDA Pre-Market Approval
FDA Class 3 ·HELISTAT(TM) ABSORBABLE COLLAGEN HEMOSTATIC SPONGE