Mitral Valve Repair Devices

FDA Pre-Market Approval

FDA Class 3 ·MITRACLIP DELIVERY SYSTEM

Mitral Valve Repair Devices

FDA Pre-Market Approval

FDA Class 3 ·PASCAL Precision Transcatheter Valve Repair System

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

FDA Pre-Market Approval

FDA Class 3 ·ARCHITECT HBSAG REAGENT KIT, CALIBRATORS, CONTROLS, CONFIRMATORY REAGENT KIT, CONFIRMATORY MANUAL DILUENT

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

FDA Pre-Market Approval

FDA Class 3 ·LIAISON® XL MUREX anti-HBe, LIAISON® XL MUREX Control anti-HBe

Over-The-Counter Automated External Defibrillator

FDA Pre-Market Approval

FDA Class 3 ·HeartStart OnSite Defibrillator (Model M5066A) and HeartStart Home Defibrillator (Model M5068A)

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval

FDA Class 3 ·BAUSCH & LOMB PUREVISION2 (BALAFILCON A) VISIBILITY TINTED CONTACT LENSES, BASUCH & LOMB PUREVISION2 MULTI-FOCAL (BALAFI

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

FDA Pre-Market Approval

FDA Class 3 ·CONCERTO MODELS C154DWK / C164AWK CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATORS

System, Colorectal Neoplasia, Rna Markers And Hemoglobin Detection

FDA Pre-Market Approval

FDA Class 3 ·ColoSense®

Excimer Laser System

FDA Pre-Market Approval

FDA Class 3 ·NIDEK 2000 EC-5000 EXCIMER LASER SYSTEM

Implanted Brain Stimulator For Epilepsy

FDA Pre-Market Approval

FDA Class 3 ·NeuroPace RNS System

Stimulator, Bone Growth, Non-Invasive

FDA Pre-Market Approval

FDA Class 3 ·ORTHOPAK BONE GROWTH STIMULATOR

Implant, Corneal, Refractive

FDA Pre-Market Approval

FDA Class 3 ·KAMRA INLAY

Automated Breast Ultrasound

FDA Pre-Market Approval

FDA Class 3 ·SOMO-V AUTOMATED BREAST ULTRASOUND SYSTEM

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·VARIOUS FAMILIES OF PACEMAKERS, CARELINK MONITOR, CARDIO SIGHT READER

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval

FDA Class 3 ·SOFT-55 EW APHAKIC, VIFILCON A(SOFT CONTACTS FOR EXTENDED WEAR)

Implant, Cochlear

FDA Pre-Market Approval

FDA Class 3 ·NUCLEUS 22 CHANNEL COCHLEAR IMPLANT SYSTEM

System, Colorectal Neoplasia, Rna Markers And Hemoglobin Detection

FDA Pre-Market Approval

FDA Class 3 ·ColoSense

Agent, Absorbable Hemostatic, Collagen Based

FDA Pre-Market Approval

FDA Class 3 ·GELFOAM (ABSORABLE GELATIN) POWDER, USP

System, Endovascular Graft, Aortic Aneurysm Treatment

FDA Pre-Market Approval

FDA Class 3 ·ZENITH ALPHA THORACIC ENDOVASCULAR GRAFT

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·VIRTUOSO MODELS D154AWG / D154VWC IMPLANTABLE CARDIOVERTER DEFIBRILLATORS