1,859 results · 53ms · Sources: EU EUDAMED, US FDA

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

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

Generator, Shock-Wave, For Pain Relief

FDA Pre-Market Approval
FDA Class 3 ·SIEMENS SONOCUR BASIC EXTRACORPOREAL SHOCK WAVE THERAPY (ESWT) 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-L

Automated External Defibrillators (Non-Wearable)

FDA Pre-Market Approval
FDA Class 3 ·HeartStart FRx Defibrillator (861304)

Over-The-Counter Automated External Defibrillator

FDA Pre-Market Approval
FDA Class 3 ·HeartStart Onsite Defibrillator (M5066A), HeartStart Home Defibrillator (M5068A), HeartStart HS1 SMART Pads, Adult (M507

Sensor, Glucose, Invasive

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

Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)

FDA Pre-Market Approval
FDA Class 3 ·BIO-RAD MONOLISA ANTI-HBC IGM EIA

Prosthesis, Intervertebral Disc

FDA Pre-Market Approval
FDA Class 3 ·ACTIVL 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

Wearable Automated External Defibrillator

FDA Pre-Market Approval
FDA Class 3 ·LifeVest Device

Cap, Cooling (Infants)

FDA Pre-Market Approval
FDA Class 3 ·OLYMPIC COOL-CAP SYSTEM

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

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

Wearable Automated External Defibrillator

FDA Pre-Market Approval
FDA Class 3 ·LifeVest Wearable Defibrillator, Model 5100

Wearable Automated External Defibrillator

FDA Pre-Market Approval
FDA Class 3 ·ASSURE Wearable Cardioverter Defibrillator system (ASSURE system)

Wearable Automated External Defibrillator

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