Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval

FDA Class 3 ·METHAFILCON A AND METHAFILCON B SOFT HYDROPHILIC WEAR CONTACT LENSES INSTALLATION AND VALIDATION OF A NEW 3M ATTEST 290

Heart-Valve, Non-Allograft Tissue

FDA Pre-Market Approval

FDA Class 3 ·MITROFLOW AORTIC PERICARDIAL HEART VALVE

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

FDA Pre-Market Approval

FDA Class 3 ·VITROS IMMUNODIAGNOSTIC PRODUCTS HBSAG REAGENT PACK, CALIBRATOR, CONFIRMATORY KIT

Stimulator, Autonomic Nerve, Implanted (Depression)

FDA Pre-Market Approval

FDA Class 3 ·VNS THERAPY SYSTEM

Implant, Intragastric For Morbid Obesity

FDA Pre-Market Approval

FDA Class 3 ·ORBERA Intragastric Balloon System

Implant, Dermal, For Aesthetic Use

FDA Pre-Market Approval

FDA Class 3 ·JUVEDERM HYALURONATE GEL IMPLANTS

Laparoscopic Contraceptive Tubal Occlusion Device

FDA Pre-Market Approval

FDA Class 3 ·ADIANA PERMANENT CONTRACEPTION SYSTEM

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval

FDA Class 3 ·comfilcon A Soft (Hydrophilic) Extended Wear Contact Lenses, Biofinity Sphere/Biofinity XR Sphere, Biofinity Energys, Bi

System, Endovascular Graft, Aortic Aneurysm Treatment

FDA Pre-Market Approval

FDA Class 3 ·ENDURANTSTENT GRAFT SYSTEM; ENDURANT II STENT GRAFT SYSTEM; ENDURANT II AOTO-UNI-LIAC (AUI) STENT GRAFT SYSTEM

System, Endovascular Graft, Arteriovenous (Av) Dialysis Access Circuit Stenosis Treatment

FDA Pre-Market Approval

FDA Class 3 ·Covera Vascular Covered Stent

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

FDA Pre-Market Approval

FDA Class 3 ·Elecsys HBsAg II (100/200 tests)

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

FDA Pre-Market Approval

FDA Class 3 ·Elecsys Anti-HBc II

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

FDA Pre-Market Approval

FDA Class 3 ·Elecsys Anti-HBc IgM

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

FDA Pre-Market Approval

FDA Class 3 ·Elecsys Anti-HBc II

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

FDA Pre-Market Approval

FDA Class 3 ·Elecsys HBeAg

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

FDA Pre-Market Approval

FDA Class 3 ·Elecsys Anti-HBc IgM

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

FDA Pre-Market Approval

FDA Class 3 ·Elecsys ANti-HBs

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

FDA Pre-Market Approval

FDA Class 3 ·Elecsys Anti-HBc IgM

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·EVERA MRI XT DR SURESCAN ICD, EVERA MRI XT VR SURESCAN ICD,EVERA MRI S DR SURESCAN ICD, EVERA MRI S VR SURESCAN ICD

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

FDA Pre-Market Approval

FDA Class 3 ·IMMULITE/IMMULITE 1000 PSA, IMMULITE 2000 PSA, IMMULITE/IMMULITE 1000 Third Generation PSA