Antigen(Complexed),Prostate Specific,(Cpsa)

FDA Pre-Market Approval

FDA Class 3 ·ADVIA CENTAUR XP CPSA ASSAY ON THE ADVIA CENTAUR XP (WITH VERSION 5.0 SOFTWARE)

Stent, Urethral, Bulbous, Permanent Or Semi-Permanent

FDA Pre-Market Approval

FDA Class 3 ·UROLUME ENDOPROSTHESIS

Spinal Pedicle Screw, Fixation, Appliance System

FDA Pre-Market Approval

FDA Class 3 ·LUMBAR I/F CAGE WITH VSP SPINE SYSTEM

Tissue Graft Of 6mm And Greater

FDA Pre-Market Approval

FDA Class 3 ·ARTEGRAFT COLLAGEN VASCULAR GRAFT

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

FDA Pre-Market Approval

FDA Class 3 ·Atellica IM Hepatitis B core IgM (aHBcM)

Kit, Test, Alpha-Fetoprotein For Neural Tube Defects

FDA Pre-Market Approval

FDA Class 3 ·AUTODELFIA HAFP KIT

Prosthesis, Penis, Inflatable

FDA Pre-Market Approval

FDA Class 3 ·AMS 700 Inflatable Penile Prosthesis (IPP) with and without InhibiZone Treatment

Biologic Material, Dental

FDA Pre-Market Approval

FDA Class 3 ·Straumann Emdogain

Automated External Defibrillators (Non-Wearable)

FDA Pre-Market Approval

FDA Class 3 ·AED 3 Semi-Automatic, AED 3 Fully Automatic

Device, Incontinence, Mechanical/Hydraulic

FDA Pre-Market Approval

FDA Class 3 ·AMS 800 ARTIFICIAL URINARY SPHINCTER

Aid, Surgical, Viscoelastic

FDA Pre-Market Approval

FDA Class 3 ·STAARVISC, OPTIVISC, AND ANIKAVISC SODIUM HYALURONATE

Dressing, Wound And Burn, Interactive

FDA Pre-Market Approval

FDA Class 3 ·APLIGRAF(R)

Prosthesis, Intervertebral Disc

FDA Pre-Market Approval

FDA Class 3 ·CHARITE ARTIFICIAL DISC

Stent, Urethral, Bulbous, Permanent Or Semi-Permanent

FDA Pre-Market Approval

FDA Class 3 ·UROLUME URETHRAL STENT

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

FDA Pre-Market Approval

FDA Class 3 ·ADVIA CENTAUR AHBS ASSAY

Automated External Defibrillators (Non-Wearable)

FDA Pre-Market Approval

FDA Class 3 ·Powerheart G5 AED

Implanted Fecal Incontinence Device

FDA Pre-Market Approval

FDA Class 3 ·ACTICON ARTIFICIAL BOWEL SPHINCTER

Device, Thermal Ablation, Endometrial

FDA Pre-Market Approval

FDA Class 3 ·NOVASURE IMPEDANCE CONTROLLED ENDOMETRIAL ABLATION SYSTEM

Temporary Non-Roller Type Left Heart Support Blood Pump

FDA Pre-Market Approval

FDA Class 3 ·Impella 2.5, Impella CP, Impella 5.0 and Impella LD

Device, Thermal Ablation, Endometrial

FDA Pre-Market Approval

FDA Class 3 ·NOVASURE IMPEDENCE CONTROLLED ENDOMETRIAL ABLATION SYSTEM