Transcatheter Septal Occluder (Ventricular)

FDA classification

FDA Class 3 ·Transcatheter Septal Occluder (Ventricular)

Stent, Coronary

FDA Pre-Market Approval

FDA Class 3 ·EXPRESS 2 MR & OTW CORONARY STENT SYSTEM

Transcervical Contraceptive Tubal Occlusion Device

FDA Pre-Market Approval

FDA Class 3 ·CONCEPTUS ESSURE SYSTEM

Stimulator, Neuromuscular, Implanted

FDA Pre-Market Approval

FDA Class 3 ·NEUROCONTROL FREEHAND SYSTEM

Acid, Hyaluronic, Intraarticular

FDA Pre-Market Approval

FDA Class 3 ·EUFLEXXA

Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval

FDA Class 3 ·LiveWire TC Ablation Catheter and Safire Ablation Catheter

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

FDA Pre-Market Approval

FDA Class 3 ·Therapy Cool Path

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

FDA Pre-Market Approval

FDA Class 3 ·TactiCath Contact Force Ablation Catheter, Sensor Enabled

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

FDA Pre-Market Approval

FDA Class 3 ·FlexAbility and FlexAbility SE Ablation Catheter

Surgical Cardiac Ablation Device, For Treatment Of Atrial Fibrillation

FDA Pre-Market Approval

FDA Class 3 ·EPi-Sense ST RF Cable

Test, Urea Adult And Pediatric (Breath),

FDA Pre-Market Approval

FDA Class 3 ·BREATHTEK UBT FOR H.PYLORI KIT (BREATHTEK UBT KIT) AND PEDIATRIC UREA HYDROLYSIS RATE CALCULATION APPLICATION (PUHR-CA)

Temporary Non-Roller Type Left Heart Support Blood Pump

FDA Pre-Market Approval

FDA Class 3 ·Impella 2.5, CP, and CP with SmartAssist

Temporary Non-Roller Type Left Heart Support Blood Pump

FDA Pre-Market Approval

FDA Class 3 ·Impella 2.5, Impella CP, Impella CP with SmartAssist, Impella 5.0, and Impella LD Systems

Temporary Non-Roller Type Left Heart Support Blood Pump

FDA Pre-Market Approval

FDA Class 3 ·IMPELLA 2.5 System

Test, Urea Adult And Pediatric (Breath),

FDA Pre-Market Approval

FDA Class 3 ·PyloPlus® UBT System

Test, Urea Adult And Pediatric (Breath),

FDA Pre-Market Approval

FDA Class 3 ·PyloPlus Urea Breath Test Pro Analyzer, PyloPlus Urea Breath Test Lab Analyzer

Temporary Non-Roller Type Left Heart Support Blood Pump

FDA Pre-Market Approval

FDA Class 3 ·Impella CP Ventricular Support System

Test, Urea Adult And Pediatric (Breath),

FDA Pre-Market Approval

FDA Class 3 ·BREATHTEK UBT FOR H. PYLORI KIT AND PEDIATRIC UREA HYDROLYSIS RATE CALCULATION APPLICATION (PUHR-CA)

Test, Urea Adult And Pediatric (Breath),

FDA Pre-Market Approval

FDA Class 3 ·BREATH TEK UBT FOR H.PYLORI KIT (BREATH TEK UBT KIT) AND PEDIATRIC UREA HYDROLYSIS RATE CALCULATION APPLICATION (PUHR-CA

Temporary Non-Roller Type Left Heart Support Blood Pump

FDA Pre-Market Approval

FDA Class 3 ·Impella 2.5 System, Impella CP System and Impella CP System with SmartAssist System, Impella 5.0 System, Impella LD Syst