Pump, Infusion, Implanted, Programmable

FDA Pre-Market Approval

FDA Class 3 ·SynchroMed Infusion System, Ascenda Intratecal Catheters

Immunohistochemistry Assay, Antibody, Ki-67

FDA Pre-Market Approval

FDA Class 3 ·Ki-67 IHC pharmDx

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)

Calibrator For Alpha-Fetoprotein In Mid-Pregnancy Maternal Serum

FDA Pre-Market Approval

FDA Class 3 ·AFP MID-PREGNANCY REFERENCE PREPARATION

Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

FDA Pre-Market Approval

FDA Class 3 ·INJEX MODEL 97791 BUMPY & MODEL 97792 BI-WING ANCHOR KITS

Prosthesis, Knee, Patello/Femorotibial, Unconstrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer

FDA Pre-Market Approval

FDA Class 3 ·NATURAL-KNEE(R) AND NATURAL KNEE(R)II W/CSTI(TM)

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval

FDA Class 3 ·MEDTRONIC MODEL 5038 CAPSURE VDD-2 LEAD

Antigen, Cancer 549

FDA Pre-Market Approval

FDA Class 3 ·TRUQUANT(R) BR(TM) RIA

Pump, Infusion, Implanted, Programmable

FDA Pre-Market Approval

FDA Class 3 ·ASCENDA INTRATHECAL CATHETER MODELS 8780, 8781, 8782, 8784, 8785, 8786, AND 8787

Agent, Absorbable Hemostatic, Collagen Based

FDA Pre-Market Approval

FDA Class 3 ·VITAGEL SURGICAL HEMOSTAT

Agent, Absorbable Hemostatic, Collagen Based

FDA Pre-Market Approval

FDA Class 3 ·VITAGEL SURGICAL HEMOSTAT

Absorbable Collagen Hemostatic Agent With Thrombin

FDA Pre-Market Approval

FDA Class 3 ·VITAGEL RT3 SUTGICAL HEMOSTAT

Agent, Absorbable Hemostatic, Collagen Based

FDA Pre-Market Approval

FDA Class 3 ·VITAGEL SURGICAL HEMOSTAT (RT3)

Cap, Cervical, Contraceptive

FDA Pre-Market Approval

FDA Class 3 ·FEMCAP BARRIER CONTRACEPTIVE

Agent, Absorbable Hemostatic, Collagen Based

FDA Pre-Market Approval

FDA Class 3 ·VITAGEL SURGICAL HEMOSTAT

Agent, Absorbable Hemostatic, Collagen Based

FDA Pre-Market Approval

FDA Class 3 ·VITAGEL SURGICAL HEMOSTAT (VITAGEL)

Agent, Absorbable Hemostatic, Collagen Based

FDA Pre-Market Approval

FDA Class 3 ·VITAGEL SURGICAL HEMOSTAT

Cap, Cervical, Contraceptive

FDA Pre-Market Approval

FDA Class 3 ·FEMCAP CONTRACEPTIVE BARRIER DEVICE

Agent, Absorbable Hemostatic, Collagen Based

FDA Pre-Market Approval

FDA Class 3 ·ORTHOVITA'S VITAGEL SURGICAL HEMOSTAT