1,757 results · 19ms · Sources: EU EUDAMED, US FDA

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval
FDA Class 3 ·FINISHED METHAFILCON A CONTACT LENSES

Wearable Automated External Defibrillator

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

Wearable Automated External Defibrillator

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

Device, Hemostasis, Vascular

FDA Pre-Market Approval
FDA Class 3 ·Closer Vascular Sealing System

Implant, Dermal, For Aesthetic Use

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

Prosthesis, Intervertebral Disc

FDA Pre-Market Approval
FDA Class 3 ·prodisc® C

Stimulator, Bone Growth, Non-Invasive

FDA Pre-Market Approval
FDA Class 3 ·ActaStim-S Spine Fusion Stimulator

Prosthesis, Intervertebral Disc

FDA Pre-Market Approval
FDA Class 3 ·prodisc® L

Absorbable Collagen Hemostatic Agent With Thrombin

FDA Pre-Market Approval
FDA Class 3 ·HEMOBLAST™ Bellows

Prosthesis, Intervertebral Disc

FDA Pre-Market Approval
FDA Class 3 ·PRODISC L TOTAL REPLACEMENT

Wearable Automated External Defibrillator

FDA Pre-Market Approval
FDA Class 3 ·LifeVest Wearable Defibrillator (Model 4000)

Absorbable Collagen Hemostatic Agent With Thrombin

FDA Pre-Market Approval
FDA Class 3 ·HEMOBLAST™ Bellows

Absorbable Collagen Hemostatic Agent With Thrombin

FDA Pre-Market Approval
FDA Class 3 ·HEMOBLAST™ Bellows

Implant, Dermal, For Aesthetic Use

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

Digital Breast Tomosynthesis

FDA Pre-Market Approval
FDA Class 3 ·MAMMOMAT INSPIRATION TOMOSYNTHESIS OPTION

Prosthesis, Intervertebral Disc

FDA Pre-Market Approval
FDA Class 3 ·PRODISC-C TOTAL DISC REPLACEMENT

Wearable Automated External Defibrillator

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

Prosthesis, Intervertebral Disc

FDA Pre-Market Approval
FDA Class 3 ·SYNTHES PRODISC-L TOTAL DISC REPLACEMENT

Prosthesis, Intervertebral Disc

FDA Pre-Market Approval
FDA Class 3 ·prodisc C Total Disc Replacement

Pump, Infusion, Insulin, To Be Used With Invasive Glucose Sensor

FDA Pre-Market Approval
FDA Class 3 ·ANIMAS VIBE SYSTEM