Absorbable Collagen Hemostatic Agent With Thrombin

FDA Pre-Market Approval

FDA Class 3 ·Floseal Hemostatic Matrix

System, Hemodynamic, Implantable

FDA Pre-Market Approval

FDA Class 3 ·Cordella Pulmonary Artery Sensor System (CorPASS)

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

FDA Pre-Market Approval

FDA Class 3 ·Vysis CLL FISH Probe Kit

Excimer Laser System

FDA Pre-Market Approval

FDA Class 3 ·KREMER LASER SYSTEM

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

FDA Pre-Market Approval

FDA Class 3 ·ARCHITECT HBsAG Qualitative Reagent Kit (100/500 Test), ARCHITECT HBsAG Qualitative Confirmatory Reagent Kit

Device, Hemostasis, Vascular

FDA Pre-Market Approval

FDA Class 3 ·MynxGrip Vascular Closure Device (5F, 6F/7F), Mynx Control Vascular Closure Device (5F, 6F/7F)

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

Device, Hemostasis, Vascular

FDA Pre-Market Approval

FDA Class 3 ·MYNX VASCULAR CLOSURE DEVICE

Barrier, Absorbable, Adhesion

FDA Pre-Market Approval

FDA Class 3 ·SEPRAFILM ADHESION BARRIER

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·SOFTEC HD POSTERIOR CHAMBER INTRAOCULAR LENS

Stent, Carotid

FDA Pre-Market Approval

FDA Class 3 ·PRECISE, PRECISE RX AND PRECISE PRO RX NITINOL STENT SYSTEM

Stent, Renal

FDA Pre-Market Approval

FDA Class 3 ·PALMAZ BALLOON EXPANDABLE STENT

Barrier, Absorbable, Adhesion

FDA Pre-Market Approval

FDA Class 3 ·SEPRAFILM ADHESION BARRIER/SEPRAFILM PROCEDURE PACK

Kit, Test, Alpha-Fetoprotein For Neural Tube Defects

FDA Pre-Market Approval

FDA Class 3 ·AXSYM AFP (LN 7A48)

Device, Hemostasis, Vascular

FDA Pre-Market Approval

FDA Class 3 ·MYNX VASCULAR CLOSURE DEVICE PRODUCT FAMILY. (MYNX PRODUCT FAMILY)

Tissue Adhesive For Use In Embolization Of Brain Arteriovenous Malformations

FDA Pre-Market Approval

FDA Class 3 ·TRUFILL N-BUTYL CYANOACRYLATE (N-BCA) LIQUID EMBOLIC SYSTEM

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

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

FDA Pre-Market Approval

FDA Class 3 ·ABBOTT AXSYM FREE PSA ASSAY

Device, Hemostasis, Vascular

FDA Pre-Market Approval

FDA Class 3 ·MYNX VASCULAR CLOSURE DEVICE

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

FDA Pre-Market Approval

FDA Class 3 ·ABBOTT IMX FREE PSA