1,859 results · 19ms · Sources: EU EUDAMED, US FDA

Automated External Defibrillators (Non-Wearable)

FDA Pre-Market Approval
FDA Class 3 ·LIFEPAK Automated External Defibrillators (AEDs)

Wearable Automated External Defibrillator

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

Prosthesis, Intervertebral Disc

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

Automated External Defibrillators (Non-Wearable)

FDA Pre-Market Approval
FDA Class 3 ·LIFEPAK® CR2 Defibrillator

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 ·Bellafill Dermal Filler

Wearable Automated External Defibrillator

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

Automated External Defibrillators (Non-Wearable)

FDA Pre-Market Approval
FDA Class 3 ·Infant/Child Reduced Energy Defibrillation Electrodes

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 ·ASSURE Wearable Cardioverter Defibrillator system (ASSURE system)

Digital Breast Tomosynthesis

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

Acid, Hyaluronic, Intraarticular

FDA Pre-Market Approval
FDA Class 3 ·TRIVISC

Gases Used Within Eye To Place Pressure On Detached Retina

FDA Pre-Market Approval
FDA Class 3 ·ISPAN SULFUR HEXAFLUORIDE SF6 GAS

Prosthesis, Intervertebral Disc

FDA Pre-Market Approval
FDA Class 3 ·SECURE-C CERVICAL ARTIFICIAL DISC

Over-The-Counter Automated External Defibrillator

FDA Pre-Market Approval
FDA Class 3 ·HeartStart OnSite Defibrillator (Model M5066A) and HeartStart Home Defibrillator (Model M5068A)

Over-The-Counter Automated External Defibrillator

FDA Pre-Market Approval
FDA Class 3 ·HeartStart OnSite Defibrillator, and HeartStart Home Defibrillator

Gases Used Within Eye To Place Pressure On Detached Retina

FDA Pre-Market Approval
FDA Class 3 ·ISPAN PERFLUOROPROPANE C3F8 GAS

Prosthesis, Intervertebral Disc

FDA Pre-Market Approval
FDA Class 3 ·SECURE -C CERVICAL ARTIFICIAL DISC

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