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

Agent, Bulking, Injectable For Gastro-Urology Use

FDA Pre-Market Approval
FDA Class 3 ·DURASPHERE EXP

Normothermic Preservation System For Transplantation Of Initially Unacceptable Donor Lungs

FDA Pre-Market Approval
FDA Class 3 ·XVIVO Perfusion System (XPS™) with STEEN Solution™ Perfusate

Agent, Bulking, Injectable For Gastro-Urology Use

FDA Pre-Market Approval
FDA Class 3 ·DURASPHERE EXP

Processor, Cervical Cytology Slide, Automated

FDA Pre-Market Approval
FDA Class 3 ·MONOPREP PAP TEST

Processor, Cervical Cytology Slide, Automated

FDA Pre-Market Approval
FDA Class 3 ·MONOPREP PAP TEST

Processor, Cervical Cytology Slide, Automated

FDA Pre-Market Approval
FDA Class 3 ·MONOPREP PAP TEST

Processor, Cervical Cytology Slide, Automated

FDA Pre-Market Approval
FDA Class 3 ·MONOPREP PAP TEST

Processor, Cervical Cytology Slide, Automated

FDA Pre-Market Approval
FDA Class 3 ·MONOPREP PAP TEST

Processor, Cervical Cytology Slide, Automated

FDA Pre-Market Approval
FDA Class 3 ·MONOPREP PAP TEST

Processor, Cervical Cytology Slide, Automated

FDA Pre-Market Approval
FDA Class 3 ·MONOPREP PAP TEST

Processor, Cervical Cytology Slide, Automated

FDA Pre-Market Approval
FDA Class 3 ·MONOPREP PAP TEST

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval
FDA Class 3 ·VIGOR DR/SR/DISCOVER/MERIDIAN/PDP

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval
FDA Class 3 ·VIGOR DR/SR/DISCOVER/MERIDIAN/PDP

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval
FDA Class 3 ·VIGOR DR/SR & DISCOVER/MERIDIAN, PDP

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

Processor, Cervical Cytology Slide, Automated

FDA Pre-Market Approval
FDA Class 3 ·BD PrepStain System, BD Totalys MultiProcessor, BD Totalys SlidePre, BD SurePath Liquid-based Pap Test

Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval
FDA Class 3 ·NAVISTAR THERMOCOOL DEFLECTABLE DIAGNOSTIC/ABLATION CATHETER