System, Laser, Photodynamic Therapy

FDA Pre-Market Approval

FDA Class 3 ·PHOTOFRIN 630 PDT Laser

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 ·ARCHITECT AUSAB REAGENT KIT, ARCHITECT AUSAB CALIBRATORS, ARCHITECT AUSAB CONTROLS

Barrier, Absorbable, Adhesion

FDA Pre-Market Approval

FDA Class 3 ·SEPRAFILM BIORESORBABLE MEMBRANE

Kit, Test, Alpha-Fetoprotein For Neural Tube Defects

FDA Pre-Market Approval

FDA Class 3 ·Architect AFP and Alinity i AFP

Kit, Dna Detection, Human Papillomavirus

FDA Pre-Market Approval

FDA Class 3 ·Alinity m HR HPV Assay

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

FDA Pre-Market Approval

FDA Class 3 ·THE PATH VYSION HER-2 DNA PRODE KIT

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

FDA Pre-Market Approval

FDA Class 3 ·ARCHITECT FREE PSA

Test, Fluorescence In Situ Hybridization (Fish), For Bladder Cancer Detection And Monitoring For Recurrence

FDA Pre-Market Approval

FDA Class 3 ·UROVYSION BLADDER CANCER KIT ASSAY

Kit, Test, Alpha-Fetoprotein For Neural Tube Defects

FDA Pre-Market Approval

FDA Class 3 ·AXSYM AFP (LN 7A48)

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

FDA Pre-Market Approval

FDA Class 3 ·CORAB

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

FDA Pre-Market Approval

FDA Class 3 ·ARCHITECT HBSAG/CONFIRMATORY

Agent, Absorbable Hemostatic, Collagen Based

FDA Pre-Market Approval

FDA Class 3 ·FLOSEAL MATRIX(R)/PROCEED(R) HEMOSTATIC SEALANTS (DRY FORM)

Kit, Assay, Progesterone Receptor

FDA Pre-Market Approval

FDA Class 3 ·IMMUNOCYTOCHEMICAL ASSAY TO DETECT PROGESTERONE

Sealant, Polymerizing

FDA Pre-Market Approval

FDA Class 3 ·ARTERX SURGICAL SEALANT 2.5ML AND 5.0 FILL VOLUMES

Hepatitis Viral B Dna Detection

FDA Pre-Market Approval

FDA Class 3 ·Alinity m HBV

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

FDA Pre-Market Approval

FDA Class 3 ·AXSYM TOTAL PSA & ARCHITECT TOTAL PSA

Separator For Therapeutic Purposes, Membrane Automated Blood Cell/Plasma

FDA Pre-Market Approval

FDA Class 3 ·PRISMAFLEX TPE 2000 WITH PLASMAFILTER PF2000N

Implant, Corneal, Refractive

FDA Pre-Market Approval

FDA Class 3 ·INTACS® Corneal Implants

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

FDA Pre-Market Approval

FDA Class 3 ·ARCHITECT CORE / Alinity i Anti-HBc