Lithotriptor, Extracorporeal Shock-Wave, Urological

FDA Pre-Market Approval

FDA Class 2 ·DORNIER MPL 9000 - MOBILE LITHOTRIPTER

Lithotriptor, Extracorporeal Shock-Wave, Urological

FDA Pre-Market Approval

FDA Class 2 ·DORNIER MPL 9000 - RENAL APPLICATION

Lithotriptor, Extracorporeal Shock-Wave, Urological

FDA Pre-Market Approval

FDA Class 2 ·DORNIER MPL 9000 - RENAL APPLICATION

Immunohistochemistry Assay, Antibody, Ki-67

FDA Pre-Market Approval

FDA Class 3 ·Ki-67 IHC MIB-1 pharmDx (Dako Omnis)

Immunohistochemistry Assay, Antibody, Ki-67

FDA Pre-Market Approval

FDA Class 3 ·Ki-67 IHC MIB-1 pharmDx (Dako Omnis)

Kit, Dna Detection, Human Papillomavirus

FDA Pre-Market Approval

FDA Class 3 ·CERVISTA HPV 16/18

Immunohistochemistry Assay, Antibody, Ki-67

FDA Pre-Market Approval

FDA Class 3 ·Ki-67 IHC pharmDx

Pump, Infusion, Implanted, Programmable

FDA Pre-Market Approval

FDA Class 3 ·Implantable System for Remodulin (ISR)

Pump, Infusion, Implanted, Programmable

FDA Pre-Market Approval

FDA Class 3 ·SynchroMed Infusion System and Ascenda Intrathecal Catheters

Kit, Dna Detection, Human Papillomavirus

FDA Pre-Market Approval

FDA Class 3 ·digene HC2 High-Risk HPB DNA Test and digene HC2 HPV DNA Test

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

FDA Pre-Market Approval

FDA Class 3 ·SIEMENS IMMULITE PSA AND THIRD GENERATION PSA ASSAYS ON THE IMMULITE, IMMULITE 1000, 2000 AND IMMULITE 2500 ANALYZERS

System, Test, Her-2/Neu, Ihc

FDA Pre-Market Approval

FDA Class 3 ·PATHWAY HER-2/NEU (4B5) RABBIT MONOCLONAL PRIMARY ANTIBODY

Agent, Bulking, Injectable For Gastro-Urology Use

FDA Pre-Market Approval

FDA Class 3 ·ENTERYX PROCEDURE KIT

Agent, Bulking, Injectable For Gastro-Urology Use

FDA Pre-Market Approval

FDA Class 3 ·ENTERYX PROCEDURE KIT, MODEL M000572600

Agent, Bulking, Injectable For Gastro-Urology Use

FDA Pre-Market Approval

FDA Class 3 ·ENTERYX PROCEDURE KIT

Agent, Bulking, Injectable For Gastro-Urology Use

FDA Pre-Market Approval

FDA Class 3 ·ENTERYX PROCEDURE KIT

Agent, Bulking, Injectable For Gastro-Urology Use

FDA Pre-Market Approval

FDA Class 3 ·ENTERYX PROCEDURE KIT

Hepatitis A Test (Antibody And Igm Antibody)

FDA Pre-Market Approval

FDA Class 2 ·DIASORIN ETI-HA-IGMK PLUS

Hepatitis A Test (Antibody And Igm Antibody)

FDA Pre-Market Approval

FDA Class 2 ·AB-HAVK, ETI-AB-HAVK, ETI-AB-HAVK PLUS

Device, Hemostasis, Vascular

FDA Pre-Market Approval

FDA Class 3 ·Perclose ProGlide Suture-Mediated Closure System, Perclose ProStyle Suture-Mediated Closure and Repair System