65 results · 19ms · Sources: EU EUDAMED, US FDA

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

Excimer Laser System

FDA Pre-Market Approval
FDA Class 3 ·NIDEK 2000 EC-5000 EXCIMER LASER SYSTEM

Excimer Laser System

FDA Pre-Market Approval
FDA Class 3 ·WAVELIGHT ALLEGRETTO WAVE EXCIMER LASER SYSTEM

Automated Breast Ultrasound

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

Excimer Laser System

FDA Pre-Market Approval
FDA Class 3 ·NIDEK EC-5000 EXCIMER LASER SYSTEM

Excimer Laser System

FDA Pre-Market Approval
FDA Class 3 ·VISX STAR EXCIMER LASER SYSTEM

Excimer Laser System

FDA Pre-Market Approval
FDA Class 3 ·NIDEK EXCLAIMER LASER SYSTEM EC-5000

Excimer Laser System

FDA Pre-Market Approval
FDA Class 3 ·BAUSCH & LOMB TECHNOLAS 217Z ZYOPTIX SYSTEM FOR PERSONALIZED VISION CORRECTION

Excimer Laser System

FDA Pre-Market Approval
FDA Class 3 ·WAVELIGHT ALLEGRETTO WAVE EXCIMER LASER SYSTEM

Excimer Laser System

FDA Pre-Market Approval
FDA Class 3 ·WAVELIGHT EX500 LASER SYSTEM

Excimer Laser System

FDA Pre-Market Approval
FDA Class 3 ·WAVELIGHT EX500 LASER SYSTEM

Excimer Laser System

FDA Pre-Market Approval
FDA Class 3 ·BAUSCH & LOMB TECHNOLAS 217Z ZYOPTIX LASER SYSTEM

Excimer Laser System

FDA Pre-Market Approval
FDA Class 3 ·TECHNOLAS 217A EXCIMER LASER SYSTEM