Sensor, Glucose, Invasive

FDA Pre-Market Approval

FDA Class 3 ·PARADIGM REAL-TIME INSULIN PUMP, PARADIGM REAL-TIME REVEL INSULIN PUMP

Automated Insulin Dosing , Threshold Suspend

FDA Pre-Market Approval

FDA Class 3 ·MINIMED 530G INSULIN PUMP

Implant, Cochlear

FDA Pre-Market Approval

FDA Class 3 ·CPI SWITCH BOX

Automated External Defibrillators (Non-Wearable)

FDA Pre-Market Approval

FDA Class 3 ·Defibtech Lifeline, Defibtech Lifeline AUTO, Defibtech Lifeline VIEW, Defibtech Lifeline VIEW AUTO, Defibtech Lifeline E

Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P)

FDA Pre-Market Approval

FDA Class 3 ·Sentus ProMRI OTW QP S, Sentus ProMRI OTW QP S-xx/49, Sentus ProMRI OTW QP L, Sentus ProMRI OTW QP Lxx/49m, Evia HF, Evi

Sensor, Glucose, Invasive

FDA Pre-Market Approval

FDA Class 3 ·PARADIGM REAL-TIME INSULIN PUMP

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

FDA Pre-Market Approval

FDA Class 3 ·RHYTHMIA HDx™ Ablation Connection Box (for INTELLAGEN™); Rhythmia HDx™ Ablation Connection Box (Maestro™)

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

FDA Pre-Market Approval

FDA Class 3 ·RHYTHMIA HDx™ Ablation Connection Box (for INTELLAGEN™); Rhythmia HDx™ Ablation Connection Box (Maestro™);RHYTHMIA HDx™

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

FDA Pre-Market Approval

FDA Class 3 ·Maestro™ Ablation Connection Box, IntellaNav™ OI

Ventilator, High Frequency

FDA Pre-Market Approval

FDA Class 3 ·LIFE PULSE HIGH FREQUENCY VENTILATOR, PATIENT BOX

Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval

FDA Class 3 ·RHYTHMIA HDx™ Ablation Connection Box (for INTELLAGEN™)

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

FDA Pre-Market Approval

FDA Class 3 ·Maestro™ Ablation Connection Box, IntellaNav™ XP and IntellaNav™ MiFi XP

Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P)

FDA Pre-Market Approval

FDA Class 3 ·Corox OTW BP; Corox OTW-L BP; Corox ProMRI OTW BP; Sentus ProMRI OTW QP S; Sentus ProMRI OTW QP S-xx/49; Corox OTW-S BP;

Applicator, Hyperthermia, Interstitial

FDA Pre-Market Approval

FDA Class 3 ·VH8500 HYPERTHERMIA TREATMENT SYSTEM

Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Metal/Polymer, Mobile Bearing

FDA Pre-Market Approval

FDA Class 3 ·LCS TOTAL KNEE SYSTEM-ADDITION OF ROTATING PLATFORM TIBIAL TRAY WITH KEEL

Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Metal/Polymer, Mobile Bearing

FDA Pre-Market Approval

FDA Class 3 ·Zimmer NexGen LPS-Flex Mobile and LPS Mobile Bearing Knee System

Stent, Coronary

FDA Pre-Market Approval

FDA Class 3 ·MULTI-LINK 8 CORONARY STENT SYSTEM

Stent, Coronary

FDA Pre-Market Approval

FDA Class 3 ·MULTI-LINK VISION CORONARY STENT SYSTEMS

Applicator, Hyperthermia, Interstitial

FDA Pre-Market Approval

FDA Class 3 ·VOL. HYPERTHERMIA TREATMENT SYSTEM MODAL VH8500

Prosthesis, Hip, Semi-Constrained, Ceramic-On-Metal Articulation

FDA Pre-Market Approval

FDA Class 3 ·PINNACLE COMPLETE ACETABULAR HIP SYSTEM