System, Pacing, Temporary, Acute, Internal Atrial Defibrillation

FDA Pre-Market Approval

FDA Class 3 ·ALERT SYSTEM-COMPANION II

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

FDA Pre-Market Approval

FDA Class 3 ·ELECSYS TOTAL PSA IMMUNOASSAY AND ELECYS TOTAL PSA CALSET

Lens, Intraocular, Phakic

FDA Pre-Market Approval

FDA Class 3 ·VISIAN IMPLANTABLE COLLAMER LENS FOR MYOPIA (MICL)

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

FDA Pre-Market Approval

FDA Class 3 ·VIDAS TOTAL PSA (TPSA) ASSAY

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

FDA Pre-Market Approval

FDA Class 3 ·ARCHITECT TOTAL PSA

System, Pacing, Temporary, Acute, Internal Atrial Defibrillation

FDA Pre-Market Approval

FDA Class 3 ·RESPONSE CV CARDIOVERSION ELECTROPHYSIOLOGY CATHETER

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

FDA Pre-Market Approval

FDA Class 3 ·Elecsys total PSA Test System

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

FDA Pre-Market Approval

FDA Class 3 ·ARCHITECT Total PSA, Alinity i Total PSA

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

FDA Pre-Market Approval

FDA Class 3 ·ELECSYS TOTAL PSA IMMUNOASSAY

Lens, Intraocular, Phakic

FDA Pre-Market Approval

FDA Class 3 ·COLLAMER VISIAN IMPLANTABLE COLLAMER LENS MICL

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

FDA Pre-Market Approval

FDA Class 3 ·ELECSYS TOTAL PSA CALSET

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

FDA Pre-Market Approval

FDA Class 3 ·ARCHITECT Total PSA / Alinity i Total PSA

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

FDA Pre-Market Approval

FDA Class 3 ·ADVIA CENTAUR PSA ASSAY

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

FDA Pre-Market Approval

FDA Class 3 ·ARCHITECT TOTAL PSA

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

FDA Pre-Market Approval

FDA Class 3 ·DIMENSION VISTA TPSA FLEX REAGENT CARTRIDGE

Lens, Intraocular, Phakic

FDA Pre-Market Approval

FDA Class 3 ·Visian Implantable Collamer Lens for Myopia

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

FDA Pre-Market Approval

FDA Class 3 ·ABBOTT ARCHITECT TOTAL PSA

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

FDA Pre-Market Approval

FDA Class 3 ·Elecsys total PSA

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

FDA Pre-Market Approval

FDA Class 3 ·Access Hybritech PSA Reagents on the Access Immunoassy Systems

Lens, Intraocular, Phakic

FDA Pre-Market Approval

FDA Class 3 ·STAAR SURGICAL IMPLANTABLE COLLAMER LENS FOR MYOPIA