85 results · 20ms · Sources: EU EUDAMED, US FDA

Digital Breast Tomosynthesis

FDA Pre-Market Approval
FDA Class 3 ·SENOCLAIRE

Digital Breast Tomosynthesis

FDA Pre-Market Approval
FDA Class 3 ·MAMMOMAT Revelation with Tomosynthesis Option System

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval
FDA Class 3 ·ENRHYTHM

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval
FDA Class 3 ·MAXIMO II, SECURA AND VIRTUOSO II

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval
FDA Class 3 ·CONCERTO II, CONSULTA AND MAXIMO II

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval
FDA Class 3 ·CLARITY /VITATRON DA+ C-SERIES/DIAMOND 3/JADE 3/RUBY 3/VITATRON DA+ T-SERIES/TOPAZ 3/VITA 2/VITA IPGS

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval
FDA Class 3 ·CLARITY/VITATRON DA+C-SERIES/DIAMOND 3/JADE 3/RUBY 3/VITATRON DA+T-SERIES/TOPAZ 3/VITA 2/VITA IPGS

Digital Breast Tomosynthesis

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

Digital Breast Tomosynthesis

FDA Pre-Market Approval
FDA Class 3 ·SENOCLAIRE

Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter

FDA Pre-Market Approval
FDA Class 3 ·BIOSENSE WEBSTER NAVISTAR/CELSIUS THERMO COOL DIAGNOSTIC/ABLATION DEFLECTABLE TIP CATHETERS

Sensor, Glucose, Invasive

FDA Pre-Market Approval
FDA Class 3 ·Paradigm REAL-Time Revel Insulin Pump

Automated Insulin Dosing , Threshold Suspend

FDA Pre-Market Approval
FDA Class 3 ·MINIMED 530G INSULIN PUMP

Sensor, Glucose, Invasive

FDA Pre-Market Approval
FDA Class 3 ·Paradigm REAL-Time Insulin Pump

Digital Breast Tomosynthesis

FDA Pre-Market Approval
FDA Class 3 ·SENOGRAPHE PRISTINA 3D

Prosthesis, Spinous Process Spacer/Plate

FDA Pre-Market Approval
FDA Class 3 ·COFLEX® INTERLAMINAR TECHNOLOGY

Prosthesis, Spinous Process Spacer/Plate

FDA Pre-Market Approval
FDA Class 3 ·COFLEX INTERLAMINAR TECHNOLOGY

Prosthesis, Spinous Process Spacer/Plate

FDA Pre-Market Approval
FDA Class 3 ·COFLEX INTERLAMINAR TECHNOLOGY

Prosthesis, Spinous Process Spacer/Plate

FDA Pre-Market Approval
FDA Class 3 ·COFLEX® INTERLAMINAR TECHNOLOGY

Prosthesis, Spinous Process Spacer/Plate

FDA Pre-Market Approval
FDA Class 3 ·coflex Interlaminar Stabilization Device

Prosthesis, Spinous Process Spacer/Plate

FDA Pre-Market Approval
FDA Class 3 ·COFLEX® INTERLAMINAR TECHNOLOGY