1,610 results · 20ms · Sources: EU EUDAMED, US FDA

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval
FDA Class 3 ·KELVIN MODEL 500 UNIPOLAR CARDIAC PULSE GENERATOR

Optical Diagnostic Device For Melanoma Detection

FDA Pre-Market Approval
FDA Class 3 ·MELAFIND

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

FDA Pre-Market Approval
FDA Class 3 ·Animas Vibe System

Implant, Dermal, For Aesthetic Use

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

Tissue Adhesive For Internal Use

FDA Pre-Market Approval
FDA Class 3 ·COHERA MEDICAL TISSUEGLU SURGICAL ADHESIVE

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval
FDA Class 3 ·KELVIN MODEL 500 UNIPOLAR CARDIAC PULSE GENERATOR

Digital Breast Tomosynthesis

FDA Pre-Market Approval
FDA Class 3 ·MAMMOMAT B.brilliant with Tomosynthesis Option

Wearable Automated External Defibrillator

FDA Pre-Market Approval
FDA Class 3 ·Life Vest Wearable Defibrillator

Prosthesis, Intervertebral Disc

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

Wearable Automated External Defibrillator

FDA Pre-Market Approval
FDA Class 3 ·WEARABLE CARDIOVERTER DEFIBRILLATOR (WCD) 2000 LIFEVEST

Wearable Automated External Defibrillator

FDA Pre-Market Approval
FDA Class 3 ·LIFEVEST DEVICE

Wearable Automated External Defibrillator

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

Gases Used Within Eye To Place Pressure On Detached Retina

FDA Pre-Market Approval
FDA Class 3 ·SULFUR HEXAFLUORIDE FOR PNEUMATIC RETINOPEXY

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

Transvenous Temporary Phrenic Nerve Stimulator

FDA Pre-Market Approval
FDA Class 3 ·AeroPace® System

Optical Diagnostic Device For Melanoma Detection

FDA Pre-Market Approval
FDA Class 3 ·MELAFIND

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

Wearable Automated External Defibrillator

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