Kit, Test, Alpha-Fetoprotein For Neural Tube Defects

FDA Pre-Market Approval

FDA Class 3 ·ARCHITECT AFP / Alinity i AFP

Fluorescence In Situ Hybridization, Anaplastic Lymphoma Kinase, Gene Rearrangement

FDA Pre-Market Approval

FDA Class 3 ·Vysis ALK Break Apart FISH Probe Kit

System, Esophageal Pacing

FDA Pre-Market Approval

FDA Class 3 ·STAT PACE II

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

FDA Pre-Market Approval

FDA Class 3 ·AXSYM CORE 2.0

Absorbable Collagen Hemostatic Agent With Thrombin

FDA Pre-Market Approval

FDA Class 3 ·FLOSEAL MATRIX/FLOSEAL MATRIX HEMOSTATIC SEALANT/PROCEED HEMOSTATIC SEALANT

Stent, Renal

FDA Pre-Market Approval

FDA Class 3 ·Cordis® PALMAZ® Balloon-Expandable Stent

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval

FDA Class 3 ·VISTAKON® (senofilcon A) Brand Contact Lenses

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

FDA Pre-Market Approval

FDA Class 3 ·ARCHITECT HBSAG QUALITTATIVE/CONFIRMATORY

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval

FDA Class 3 ·VISTAKON (senofilcon A) Brand Contact Lenses

Stent, Coronary

FDA Pre-Market Approval

FDA Class 3 ·CROSSFLEX LC BALLOON EXPANDABLE STENT (ANGLED END/SQUARE END) WITH OVER THE WIRE DELIVERY SYSTEM

Absorbable Collagen Hemostatic Agent With Thrombin

FDA Pre-Market Approval

FDA Class 3 ·Floseal Hemostatic Matrix

Device, Hemostasis, Vascular

FDA Pre-Market Approval

FDA Class 3 ·EXOSEAL VASCULAR CLOSURE DEVICE

Barrier, Absorbable, Adhesion

FDA Pre-Market Approval

FDA Class 3 ·Seprafilm Adhesion Barrier

Stent, Coronary

FDA Pre-Market Approval

FDA Class 3 ·BX VELOCITY STENT W/HEPACOAT ON RAPTOR/ON SONIC OTW/ON RAPTORRAIL STENT DELIVERY SYSTEM

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

FDA Pre-Market Approval

FDA Class 3 ·ARCHITECT FREE PSA ASSAY

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·SOFTEC HD POSTERIOR CHAMBER INTRAOCULAR LENS

Fluorescence In Situ Hybridization, Anaplastic Lymphoma Kinase, Gene Rearrangement

FDA Pre-Market Approval

FDA Class 3 ·VYSIS ALK BREAK APART FISH PROBE KIT.

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval

FDA Class 3 ·VISTAKON (senofilcon A) Brand Contact Lenses

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

FDA Pre-Market Approval

FDA Class 3 ·ARCHITECT HBsAg Qualitative, HBsAg Qualitative Confirmatory, Alinity i HBsAg Qualitative II/Qualitative II Confirmatory

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)