Kit, Test, Alpha-Fetoprotein For Neural Tube Defects

FDA Pre-Market Approval

FDA Class 3 ·ACS 180/ADVIA CENTAUR AFP IMMUNOASSAY

Kit, Test, Alpha-Fetoprotein For Neural Tube Defects

FDA Pre-Market Approval

FDA Class 3 ·ADVIA Centaur and Atellica IM AFP

Kit, Test, Alpha-Fetoprotein For Neural Tube Defects

FDA Pre-Market Approval

FDA Class 3 ·ADVIA Centaur® and Atellica® IM AFP, ADVIA Centaur® and Atellica® IM PSA, ADVIA Centaur® and Atellica® IM cPSA

Kit, Test, Alpha-Fetoprotein For Neural Tube Defects

FDA Pre-Market Approval

FDA Class 3 ·Atellica IM Alpha Fetoprotien (AFP) Assay

Implant, Cochlear

FDA Pre-Market Approval

FDA Class 3 ·Chorus Sound Processor and SoundWave Professional Suite 3.2/HiResolution Bionic Ear System

Aortic Valve, Prosthesis, Percutaneously Delivered

FDA Pre-Market Approval

FDA Class 3 ·Ascendra+ Delivery System; Balloon Aortic Valvuloplasty Catheter; NovaFlex+ Delivery System; Crimper; Edwards Ballon Cat

Implant, Cochlear

FDA Pre-Market Approval

FDA Class 3 ·HIRESOLUTION BIONIC EAR SYSTEM, HIRES ULTRA COCHLEAR IMPLANT WITH THE HIFOCUS MID-SCALA ELECTRODE

Skintact, various other tradenames

FDA 510(k)

FDA Class 3 ·Cardiovascular

Heart-Valve, Mechanical

FDA Pre-Market Approval

FDA Class 3 ·Open Pivot Mechanical Heart Valve; Open Pivot Aortic Valved Graft

Heart-Valve, Mechanical

FDA Pre-Market Approval

FDA Class 3 ·ATS OPEN PIVOT BILEAFLET HEART VALVE

Heart-Valve, Mechanical

FDA Pre-Market Approval

FDA Class 3 ·MEDTRONIC OPEN PIVOT HEART VALVE AND OPEN PIVOT AORTIC VALVED GRAFT

Heart-Valve, Mechanical

FDA Pre-Market Approval

FDA Class 3 ·Open Pivot Heart Valve / Aortic Valved Graft

Heart-Valve, Mechanical

FDA Pre-Market Approval

FDA Class 3 ·Open Pivot Heart Valve

Heart-Valve, Mechanical

FDA Pre-Market Approval

FDA Class 3 ·OPEN PIVOT AORTIC VALVED GRAFT

Heart-Valve, Mechanical

FDA Pre-Market Approval

FDA Class 3 ·ATS OPEN PIVOT BILEAFLET HEART VALVES

Heart-Valve, Mechanical

FDA Pre-Market Approval

FDA Class 3 ·Open Pivot Heart Valves and Open Pivot Aortic Valved Graft

Heart-Valve, Mechanical

FDA Pre-Market Approval

FDA Class 3 ·ATS OPEN PIVOT BILEAFLET HEART VALVE

Heart-Valve, Mechanical

FDA Pre-Market Approval

FDA Class 3 ·Open Pivot Mechanical Valve (OPHV), Open Pivot Aortic Valved Graft (AVG)

Heart-Valve, Mechanical

FDA Pre-Market Approval

FDA Class 3 ·MEDTRONIC OPEN PIVOT HEART VALVE

Heart-Valve, Mechanical

FDA Pre-Market Approval

FDA Class 3 ·OPEN PIVOT HEART VALVE,OPEN PIVOT AORTIC VALVED GRAFT,OPEN PIVOT HEART VALVE-APEX,OPEN PIVOT HEART VALVE-AP360