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

FDA Pre-Market Approval

FDA Class 3 ·HBE RIA DIAGNOSTIC KIT

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

FDA Pre-Market Approval

FDA Class 3 ·ARCHITECT HBSAG & ARCHITECT HBSAG CONFIRMATORY ASSAYS

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

FDA Pre-Market Approval

FDA Class 3 ·ARCHITECT AUSAB

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

FDA Pre-Market Approval

FDA Class 3 ·ABBOTT AXSYM AUSAB

Kit, Test, Alpha-Fetoprotein For Neural Tube Defects

FDA Pre-Market Approval

FDA Class 3 ·AXSYM AFP

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

FDA Pre-Market Approval

FDA Class 3 ·ARCHITECT FREE PSA

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

FDA Pre-Market Approval

FDA Class 3 ·AXSYM CORE 2.0 (LN 8B88)

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

FDA Pre-Market Approval

FDA Class 3 ·ARCHITECT TOTAL PSA (LN 6CO6)

Separator For Therapeutic Purposes, Membrane Automated Blood Cell/Plasma

FDA Pre-Market Approval

FDA Class 3 ·Gambro Prismaflex TPE 2000 Set

Absorbable Collagen Hemostatic Agent With Thrombin

FDA Pre-Market Approval

FDA Class 3 ·Floseal Hemostatic Matrix

Fluorescence In Situ Hybridization, Chromosome 17p Deletion (Tp53)

FDA Pre-Market Approval

FDA Class 3 ·Vysis CLL FISH Probe Kit

LEAD MODIFICATION

FDA 510(k)

FDA Class 3 ·Cardiovascular

PULSTRON MODEL 100

FDA 510(k)

FDA Class 3 ·Cardiovascular

PACEMAKER, ELECTRODE, PERMANENT & TEMP.

FDA 510(k)

FDA Class 3 ·Cardiovascular

DIRECTIONAL BOOT

FDA 510(k)

FDA Class 3 ·Cardiovascular

MODIFICATION TO PORTABLE INTENSIVE CARE UNIT

FDA 510(k)

FDA Class 3 ·Cardiovascular

#325 PROGRAMMABLE CARD. PULSE GENERATOR

FDA 510(k)

FDA Class 3 ·Cardiovascular

LEAD, ENDOCARDIAL, TINED, BIPOLAR, 5MM

FDA 510(k)

FDA Class 3 ·Cardiovascular

BG PROXIMAL FEMUR

FDA 510(k)

FDA Class 3 ·Orthopedic

COMMAND NP

FDA 510(k)

FDA Class 3 ·Cardiovascular