481 results · 38ms · Sources: EU EUDAMED, US FDA

Wearable Automated External Defibrillator

FDA Pre-Market Approval
FDA Class 3 ·LIFEVEST WEARABLE DEFIBRILLATOR

Analyzer, Medical Image

FDA Pre-Market Approval
FDA Class 2 ·SECOND LOOK

Analyzer, Medical Image

FDA Pre-Market Approval
FDA Class 2 ·SECOND LOOK

Filter, Intravascular, Cardiovascular

FDA Pre-Market Approval
FDA Class 2 ·GIANTURCO-ROEHM BIRD'S NEST(TM) VENA CAVA FILTER

Analyzer, Medical Image

FDA Pre-Market Approval
FDA Class 2 ·SECOND LOOK (TM)

System, Endovascular Graft, Aortic Aneurysm Treatment

FDA Pre-Market Approval
FDA Class 3 ·ZENITH AAA ENDOVASCULAR GRAFT WITH H&L-B ONE SHOT INTRODUCTION SYSTEM

Catheter, Sampling, Chorionic Villus

FDA Pre-Market Approval
FDA Class 3 ·COOK CHORIONIC VILLUS SAMPLING SET

Device, Hemostasis, Vascular

FDA Pre-Market Approval
FDA Class 3 ·CLOSER / CLOSER S PERCUTANEOUS VASCULAR SURGERY DEVICES

Reader, Cervical Cytology Slide, Automated

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

Test, Prostate Specific Antigen, Free, (Noncomplexed) To Distinguish Prostate Cancer From Benign Conditions

FDA Pre-Market Approval
FDA Class 3 ·ADVIA Centaur PSA, ADVIA Centaur CP PSA and Atellica IM PSA

Catheter, Sampling, Chorionic Villus

FDA Pre-Market Approval
FDA Class 3 ·COOK CHORIONIC VILLUS SAMPLING SET

Catheter, Sampling, Chorionic Villus

FDA Pre-Market Approval
FDA Class 3 ·COOK CHORIONIC VILLUS SAMPLING SET

Catheter, Sampling, Chorionic Villus

FDA Pre-Market Approval
FDA Class 3 ·COOK CHORIONIC VILLUS SAMPLING SET

Catheter, Sampling, Chorionic Villus

FDA Pre-Market Approval
FDA Class 3 ·COOK CHORIONIC VILLUS SAMPLING SET

System, Test, Carcinoembryonic Antigen

FDA Pre-Market Approval
FDA Class 2 ·ABBOTT CEA-RIA MONOCLONAL

System, Endovascular Graft, Aortic Aneurysm Treatment

FDA Pre-Market Approval
FDA Class 3 ·Zenith Dissection Endovascular System

Stent, Coronary

FDA Pre-Market Approval
FDA Class 3 ·GIANTURCO-ROUBIN FLEX STENT/GRII(TM) CORONARY STENT

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval
FDA Class 2 ·COOK MBC PTCA BALLOON DILATATION CATHETER

Filter, Intravascular, Cardiovascular

FDA Pre-Market Approval
FDA Class 2 ·COOK BIRD'S NEST VENA CAVA FILTER

Filter, Intravascular, Cardiovascular

FDA Pre-Market Approval
FDA Class 2 ·COOK BIRD'S NEST VENA CAVA FILTER