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

FDA Pre-Market Approval

FDA Class 3 ·Atellica IM Prostate-Specific Antigen (PSA) Assay

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

FDA Pre-Market Approval

FDA Class 3 ·Elecsys total PSA (100/200 tests) Immunoassay

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

FDA Pre-Market Approval

FDA Class 3 ·IMMULITE/IMMULITE 1000/IMMULITE 2000 Free PSA

Antigen(Complexed),Prostate Specific,(Cpsa)

FDA Pre-Market Approval

FDA Class 3 ·ADVIA IMS PROSTATE SPECIFIC ANTIGEN ASSAY (PSA)

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

FDA Pre-Market Approval

FDA Class 3 ·ACCESS HYBRITECH FREE PSA REAGENT/CALIBRATOR KIT

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

FDA Pre-Market Approval

FDA Class 3 ·ACCESS HYBRITECH FREE PSA REAGENT/CALIBRATOR KIT

Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D)

FDA Pre-Market Approval

FDA Class 3 ·ST JUDE MEDICAL, MERLIN PSA EX3100 SYSTEM

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

FDA Pre-Market Approval

FDA Class 3 ·Atellica IM Prostate-Specific Antigen (PSA) Assay

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

FDA Pre-Market Approval

FDA Class 3 ·IMMULITE® 2000 Prostate-Specific Antigen (PSA)

Aid, Surgical, Viscoelastic

FDA Pre-Market Approval

FDA Class 3 ·BIOLON 1% SODIUM HYALURONATE FOR OPHTHALMIC SURGERY

Stimulator, Hypoglossal Nerve, Implanted, Apnea

FDA Pre-Market Approval

FDA Class 3 ·Inspire Medical Systems, Model 2580 Patient Programmer

Implant, Dermal, For Aesthetic Use

FDA Pre-Market Approval

FDA Class 3 ·HYLAFORM FAMILY DERMAL FILLERS (HYLAFORM, HYLAFORM PLUS AND CAPTIQUE INJECTABLE GEL)

Device, Hemostasis, Vascular

FDA Pre-Market Approval

FDA Class 3 ·EXOSEAL Vascular Closure Device

Agent, Absorbable Hemostatic, Collagen Based

FDA Pre-Market Approval

FDA Class 3 ·VITAGEL SURGICAL HEMOSTAT

System, Endovascular Graft, Aortic Aneurysm Treatment

FDA Pre-Market Approval

FDA Class 3 ·TALENT THORACIC STENT GRAFT SYSTEM

Implant, Dermal, For Aesthetic Use

FDA Pre-Market Approval

FDA Class 3 ·Sculptra and Sculptra Aesthetic

Ventricular (Assist) Bypass

FDA Pre-Market Approval

FDA Class 3 ·HeartWare Left Ventricular Assist System

Implant, Intragastric For Morbid Obesity

FDA Pre-Market Approval

FDA Class 3 ·RESHAPE INTEGRATED DUAL BALLOON SYSTEM, RESHAPE BALLOON ASSEMBLY, RESHAPE REMOVAL CATHETER, RESHAPE VALVE SEALANT

Implant, Dermal, For Aesthetic Use

FDA Pre-Market Approval

FDA Class 3 ·Juvéderm® Hyaluronate Gel Implants

Implant, Dermal, For Aesthetic Use

FDA Pre-Market Approval

FDA Class 3 ·Revanesse Versa 1.0 mL, Revanesse Versa 1.2 mL, Revanesse Versa + with Lidocaine 1.0 mL, Revanesse Versa + with Lidocain