1,757 results · 29ms · Sources: EU EUDAMED, US FDA

Aspiration Therapy System

FDA Pre-Market Approval
FDA Class 3 ·AspireAssist

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 ·WEARABLE CARDIOVERTER DEFIBRILLATOR (WCD) 2000 LIFEVEST

Sensor, Glucose, Invasive

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

Wearable Automated External Defibrillator

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

Absorbable Collagen Hemostatic Agent With Thrombin

FDA Pre-Market Approval
FDA Class 3 ·Hemoblast Bellows

Lens, Contact, Orthokeratology, Overnight

FDA Pre-Market Approval
FDA Class 3 ·Euclid Systems Orthokeratology (oprifocon A) Contact Lenses for Overnight Wear and Euclid Systems Orthokeratology (tisil

Wearable Automated External Defibrillator

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

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