Stimulator, Autonomic Nerve, Implanted For Epilepsy

FDA Pre-Market Approval

FDA Class 3 ·VNS THERAPY SYSTEM

Excimer Laser System

FDA Pre-Market Approval

FDA Class 3 ·LASERSIGHT LASERSCAN LSX EXCIMER LASER SYSTEM FOR LASER-ASSITED IN SITU KERATOMILEUSIS (LASIK)

Excimer Laser System

FDA Pre-Market Approval

FDA Class 3 ·LADARVISION 4000 EXCIMER LASER SYSTEM

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

FDA Pre-Market Approval

FDA Class 3 ·ABBOTT ARCHITECT TOTAL PSA

Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers

FDA Pre-Market Approval

FDA Class 2 ·ABBOTT AXSYM TOTAL PSA

Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers

FDA Pre-Market Approval

FDA Class 2 ·DIMENSION(R) RXL PSA FLEX(R) REAGENT CARTRIDGE

Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers

FDA Pre-Market Approval

FDA Class 2 ·DIMENSION TPSA FLEX REAGENT CARTRIDGE

Kit, Test, Alpha-Fetoprotein For Neural Tube Defects

FDA Pre-Market Approval

FDA Class 3 ·GAMMA DAB (125I) AFP RIA KIT

Kit, Test, Alpha-Fetoprotein For Neural Tube Defects

FDA Pre-Market Approval

FDA Class 3 ·GAMMA DAB (125I) AFP RIA KIT

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·DA+C & DA+T SERIES

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval

FDA Class 3 ·VITATRON DA+ C SERIES PULSE GENERATORS

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·VITATRON DA+C & T SERIES

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·VITATRON DA+ C & T SERIES

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

FDA Pre-Market Approval

FDA Class 3 ·ABBOTT ARCHITECT TOTAL PSA ASSAY

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·VITATRON DA+ C & T SERIES IPGS

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·DA+ C-SERIES AND DA+ T-SERIES

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·DA+ C-SERIES & DA+ T-SERIES

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·DA+C SERIES & DA+T SERIES

Analyzer, Chemistry (Photometric, Discrete), For Clinical Use

FDA Pre-Market Approval

FDA Class 1 ·ABBOTT IMX TOTAL PSA

Kit, Dna Detection, Human Papillomavirus

FDA Pre-Market Approval

FDA Class 3 ·DIGENE HYBRID CAPTURE 2 (HC2) HPV DAN TEST