7,912 results · 21ms · Sources: EU EUDAMED, US FDA

Automated Breast Ultrasound

FDA Pre-Market Approval
FDA Class 3 ·Invenia ABUS (Automated Breast Ultrasound System) 2.0

Automated Breast Ultrasound

FDA Pre-Market Approval
FDA Class 3 ·INVENIA ABUS

Automated Breast Ultrasound

FDA Pre-Market Approval
FDA Class 3 ·SoftVue™ Automated Whole Breast Ultrasound System with Sequr™ Breast Interface

Automated Breast Ultrasound

FDA Pre-Market Approval
FDA Class 3 ·Invenia ABUS Autoated Breast Ultrasound System

Automated Breast Ultrasound

FDA Pre-Market Approval
FDA Class 3 ·INVENIA ABUS- AUTOMATED BREAST ULTRASOUND SYSTEM

Automated Breast Ultrasound

FDA Pre-Market Approval
FDA Class 3 ·Invenia ABUS Premium, Invenia ABUS Prime

Automated Breast Ultrasound

FDA Pre-Market Approval
FDA Class 3 ·Invenia ABUS 2.0 Automated Breast Ultrasound System

Automated Breast Ultrasound

FDA Pre-Market Approval
FDA Class 3 ·INVENIA ABUS-AUTOMATED BREAST ULTRASOUND SYSTEM

Implant, Cochlear

FDA Pre-Market Approval
FDA Class 3 ·SONNET 2, SONNET 2 EAS, RONDO 3, MAESTRO 8, and MAESTRO 9

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

Wearable Automated External Defibrillator

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

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval
FDA Class 3 ·KELVIN (R) PACING SYSTEM

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 BEFIBRILLATOR

Prosthesis, Intervertebral Disc

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

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

Implant, Dermal, For Aesthetic Use

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