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

Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

FDA Pre-Market Approval
FDA Class 3 ·Restore, Itrel®, Synergy®, Intellis™ and Vanta™ Spinal Cord Stimulation Systems and Pisces™, Specify®, Vectris® Spinal C

Stimulator, Electrical, Implanted, For Parkinsonian Tremor

FDA Pre-Market Approval
FDA Class 3 ·Activa® Deep Brain Stimulation Therapy System, Percept™ BrainSense™

Computer-Assisted Personalized Sedation System

FDA Pre-Market Approval
FDA Class 3 ·SEDASYS COMPUTER ASSISTED PERSONALIZED SEDATION SYSTEM

Reader, Cervical Cytology Slide, Automated

FDA Pre-Market Approval
FDA Class 3 ·AUTOPAP(R) 300 QC AUTOMATIC PAP SCREENER/QC SYSTEM

Reader, Cervical Cytology Slide, Automated

FDA Pre-Market Approval
FDA Class 3 ·AUTOPAP(R) 300 QC AUTOMATIC PAP SCREENER/QC SYSTEM

Reader, Cervical Cytology Slide, Automated

FDA Pre-Market Approval
FDA Class 3 ·AUTOPAP(R) 300 QC AUTOMATIC PAP SCREENER/QC SYSTEM

Reader, Cervical Cytology Slide, Automated

FDA Pre-Market Approval
FDA Class 3 ·AUTOPAP(R) 300 QC AUTOMATIC PAP SCREENER/QC SYSTEM

Computer-Assisted Personalized Sedation System

FDA Pre-Market Approval
FDA Class 3 ·SEDASYS COMPUTER-ASSISTED PERSONALIZED SEDATION SYSTEM

Tympanostomy Tube Delivery Product With Drug

FDA Pre-Market Approval
FDA Class 3 ·Tula® System

Tympanostomy Tube Delivery Product With Drug

FDA Pre-Market Approval
FDA Class 3 ·Tula® System

Tympanostomy Tube Delivery Product With Drug

FDA Pre-Market Approval
FDA Class 3 ·Tula System

Pulmonary Stent

FDA Pre-Market Approval
FDA Class 3 ·PALMAZ MULLINS XD Pulmonary Stent

Tympanostomy Tube Delivery Product With Drug

FDA Pre-Market Approval
FDA Class 3 ·Tula® System

Tympanostomy Tube Delivery Product With Drug

FDA Pre-Market Approval
FDA Class 3 ·Tula® System

Pulmonary Stent

FDA Pre-Market Approval
FDA Class 3 ·PALMAZ MULLINS XD Pulmonary Stent

Pulmonary Stent

FDA Pre-Market Approval
FDA Class 3 ·PALMAZ MULLINS XD Pulmonary Stent

Tympanostomy Tube Delivery Product With Drug

FDA Pre-Market Approval
FDA Class 3 ·Tula System

Tympanostomy Tube Delivery Product With Drug

FDA Pre-Market Approval
FDA Class 3 ·Tula® System

Tympanostomy Tube Delivery Product With Drug

FDA Pre-Market Approval
FDA Class 3 ·Tula System

Tympanostomy Tube Delivery Product With Drug

FDA Pre-Market Approval
FDA Class 3 ·Tula SystemTube Delivery System (TDS)