Agent, Absorbable Hemostatic, Collagen Based

FDA Pre-Market Approval

FDA Class 3 ·VITAGEL SURGICAL HEMOSTAT (VITAGEL)

Sensor, Glucose, Invasive

FDA Pre-Market Approval

FDA Class 3 ·Paradigm real time Insulin Pump / Paradigm Real time revel Insulin Pump

Sensor, Glucose, Invasive

FDA Pre-Market Approval

FDA Class 3 ·Paradigm Real Time Revel Insulin Pump

System, Photopheresis, Extracorporeal

FDA Pre-Market Approval

FDA Class 3 ·THERAKOS CELLEX Photopheresis System (CELLEX), THERAKOS CELLEX Photopheresis Procedural Kit (CLXUSA and CLXECP), THERAK

Implant, Cochlear

FDA Pre-Market Approval

FDA Class 3 ·NUCLEUS COCHLEAR IMPLANT SYSTEM

Automated Insulin Dosing , Threshold Suspend

FDA Pre-Market Approval

FDA Class 3 ·ENLITE GLUCOSE SENSORS

Automated Insulin Dosing , Threshold Suspend

FDA Pre-Market Approval

FDA Class 3 ·ENLITE SENSOR

Excimer Laser System

FDA Pre-Market Approval

FDA Class 3 ·STAR S4 IR EXCIMER LASER SYSTEM WITH VARIABLE SPOT SCANNING (VSS)

Total, Prostate Specific Antigen (Noncomplexed & Complexed) For Detection Of Prostate Cancer

FDA Pre-Market Approval

FDA Class 3 ·VIDAS TOTAL PSA

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

FDA Pre-Market Approval

FDA Class 3 ·VIDAS FREE PSA RT

Device, Hemostasis, Vascular

FDA Pre-Market Approval

FDA Class 3 ·VASOSEAL ELITE VHD/ES DEVICE

Device, Hemostasis, Vascular

FDA Pre-Market Approval

FDA Class 3 ·THE CLOSER AK 6 FR. SMC DEVICE

Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)

FDA Pre-Market Approval

FDA Class 3 ·ARCHITECT CORE REAGENT KIT, ARCHITECT CORE CALIBRATOR AND ARCHITECT CORE CONTROLS

Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)

FDA Pre-Market Approval

FDA Class 3 ·AB-CORE K HEPATITIS B CORE ANTIGEN 125I

Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)

FDA Pre-Market Approval

FDA Class 3 ·AXSYM CORE 2.0 & AXSYM CORE 2.0 CONTROLS

Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)

FDA Pre-Market Approval

FDA Class 3 ·AB-CORE K HEPATITIS B CORE ANTIGEN 125I

Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)

FDA Pre-Market Approval

FDA Class 3 ·AB-CORE K HEPATITIS B CORE ANTIGEN 125I

Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)

FDA Pre-Market Approval

FDA Class 3 ·AXSYM CORE 2.0 AND AXSYM CORE 2.0 CONTROLS

Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)

FDA Pre-Market Approval

FDA Class 3 ·ARCHITECT CORE

Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)

FDA Pre-Market Approval

FDA Class 3 ·ARCHITECT CORE