P2psa

FDA Pre-Market Approval

FDA Class 3 ·ACCESS HYBRITECH P2PSA ON THE ACCESS IMMUNOASSAY SYSTEMS

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

FDA Pre-Market Approval

FDA Class 3 ·ACCESS HYBRITECH FREE PSA ON THE ACCESS 2 IMMUNOASSAY ANALYZER

Biologic Material, Dental

FDA Pre-Market Approval

FDA Class 3 ·Straumann Emdogain

Antigen(Complexed),Prostate Specific,(Cpsa)

FDA Pre-Market Approval

FDA Class 3 ·COMPLEXED PSA MICROTITER ELISA

Prostrate Cancer Genes Nucleic Acid Amplification Test System

FDA Pre-Market Approval

FDA Class 3 ·PROGENSA PCA3 ASSAY

Stent, Coronary

FDA Pre-Market Approval

FDA Class 3 ·THUNDER HIGH SCAFFORDING OVER-THE-WIRE AND RAPID EXCHANGE SAPHENOUS VEIN GRAFT STENT SYSTEMS

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

FDA Pre-Market Approval

FDA Class 3 ·TANDEM-R FREE PSA IMMUNORADIOMETRIC ASSAY/TANDEM-MP FREE PSA IMMUNOENZYMETRIC ASSAY

Nitric Oxide Generator And Delivery System

FDA Pre-Market Approval

FDA Class 3 ·LungFit PH

Multi-Analyte Test System With Algorithmic Analysis For Detection Of Prostate Cancer

FDA Pre-Market Approval

FDA Class 3 ·4Kscore Test

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

FDA Pre-Market Approval

FDA Class 3 ·FPSA FLEX REAGENT CARTRIDGE

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

FDA Pre-Market Approval

FDA Class 3 ·DIMENSION FPSA FLEX REAGENT CARTRIDGE

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

FDA Pre-Market Approval

FDA Class 3 ·DIMENSION VISTA TPSA FLEX REAGENT CARTRIDGE

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

FDA Pre-Market Approval

FDA Class 3 ·DIMENSION FPSA FLEX REAGENT CARTRIDGE AND DIMENSION T/F PSA CALIBRATOR FOR DIMENSION RXL AND XPAND SYSTEMS

IMPLANTABLE PULSE DEVICES

FDA 510(k)

FDA Class 3 ·Cardiovascular

SKINTACT PEDIATRIC MULTIFUNCTION ELECTRODES WITH DH03 GEL

FDA 510(k)

FDA Class 3 ·Cardiovascular

MEDTRONIC 6304, 6305,6306,6506 & 6506W. TEMP.PACIN

FDA 510(k)

FDA Class 3 ·Cardiovascular

MODIFIED UNIPOLAR IMPLANT. PACING LEADS W/IS-1

FDA 510(k)

FDA Class 3 ·Cardiovascular

MYOPORE(TM) UNIPOLAR MODELS 1117 & 1118 PACE LEADS

FDA 510(k)

FDA Class 3 ·Cardiovascular

IMPLANTABLE PACING LEADS W/IS-1 CONN., UNIPOLAR

FDA 510(k)

FDA Class 3 ·Cardiovascular

MEDTRONIC MODEL 4081,4581,4582 TARGET TIP PACING L

FDA 510(k)

FDA Class 3 ·Cardiovascular