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

FDA Pre-Market Approval

FDA Class 3 ·IMMULITE/IMMULITE 1000 & IMMULITE 2000 ANTI-HBC

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

FDA Pre-Market Approval

FDA Class 3 ·IMMULITE/IMMULITE 1000 & IMMULITE 2000 ANTI-HBC

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

FDA Pre-Market Approval

FDA Class 3 ·IMMULITE/IMMULITE 1000 & IMMULITE 2000 ANTI-HBS

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

FDA Pre-Market Approval

FDA Class 3 ·IMMULITE/IMMULITE 1000 & IMMULITE 2000 HBSAG & 2000 HBSAG CONFIRMATORY

Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval

FDA Class 3 ·RF Marinr, Unipolar Mapping RF Marinr, RF Conductr MC, RF Enhancr, and RF Contactr

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

FDA Pre-Market Approval

FDA Class 3 ·IMMULITE/IMMULITE 1000 FREE PSA AND IMMULITE 2000 FREE PSA

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

FDA Pre-Market Approval

FDA Class 3 ·IMMULITE/IMMULITE 1000 PSA, IMMULITE 2000 PSA, IMMULITE/IMMULITE 1000 & 2000 THIRD GENERATION PSA

Kit, Test, Alpha-Fetoprotein For Neural Tube Defects

FDA Pre-Market Approval

FDA Class 3 ·IMMULITE/IMMULITE 1000 AFP AND IMMULITE 2000/IMMULITE 2500 AFP

Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval

FDA Class 3 ·RF Conductr MC; RF Marinr 5Fr; RF Marinr 7Fr; and Unipolar Mapping RF Marinr 7Fr

Stent, Coronary

FDA Pre-Market Approval

FDA Class 3 ·MAGIC WALLSTENT EDNDOPROSTHESIS AND RADIUS CORONARY STENT WITH DELIVERY SYSTEM

Barrier, Absorbable, Adhesion

FDA Pre-Market Approval

FDA Class 3 ·INTERCEED (TC7) ABSORBABLE ADHESION BARRIER

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval

FDA Class 3 ·BIOMEDICS 38 (POLYMACON) HYDROPHILIC CONTACT LENSES

System, Test, Her-2/Neu, Nucleic Acid Or Serum

FDA Pre-Market Approval

FDA Class 3 ·HER2 FISH PHARMDX KIT

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval

FDA Class 3 ·MEDTRONIC KAPPA 700 SERIES PULSE GENERATOR PRODUCT FAMILY

Filler, Bone Void, Non-Osteoinduction

FDA Pre-Market Approval

FDA Class 3 ·COLLAGRAFT STRIP BONE GRAFT MATRIX

Permanent Pacemaker Electrode

FDA Pre-Market Approval

FDA Class 3 ·THINLINE/FINELINE

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval

FDA Class 3 ·MEDTRONIC KAPPA 900/800 SERIES PLUSE GENERATORS

Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D)

FDA Pre-Market Approval

FDA Class 3 ·VARIOUS INSYNC FAMILIES OF CRT-ICDS

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·IMPLANTABLE PACEMAKER

System, Hyperthermia, Rf/Microwave (Benign Prostatic Hyperplasia),Thermotherapy

FDA Pre-Market Approval

FDA Class 3 ·PROLIEVE THERMODILATATION SYSTEM CATHETER AND HEAT EXCHANGER