Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·FORTIFY, FORTIFY ASSURA, ELLIPSE FAMILY OF ICDS

Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D)

FDA Pre-Market Approval

FDA Class 3 ·UNIFY, UNIFY ASSURA, QUADRA ASSURA FAMILY OF CRT-D'S

Immunohistochemistry Assay, Antibody, Anaplastic Lymphoma Kinase

FDA Pre-Market Approval

FDA Class 3 ·VENTANA ALK (D5F3)

System, Test, Her-2/Neu, Ihc

FDA Pre-Market Approval

FDA Class 3 ·PATHWAY anti-HER-2/neu (4B5) Rabbit Monoclonal Primary Antibody

Chromogenic In Situ Hybridization, Nucleic Acid Amplification, Her2/Neu Gene, Breast Cancer

FDA Pre-Market Approval

FDA Class 3 ·INFORM HER2 Dual ISH DNA Probe Cocktail

Immunohistochemistry Antibody Assay, C-Kit

FDA Pre-Market Approval

FDA Class 3 ·PATHWAY ANTI-C-KIT

Lens, Multifocal Intraocular

FDA Pre-Market Approval

FDA Class 3 ·SOFT ACRYLIC INTRAOCULAR LENSES (IOLS)

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·SOFT ACRYLIC INTRAOCULAR LENSES (IOLS)

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·SOFT ACRYLIC INTRAOCULAR LENSES (IOLS)

Sealant, Dural

FDA Pre-Market Approval

FDA Class 3 ·Adherus AutoSpray Dural Sealant, NUS-106

Sealant, Dural

FDA Pre-Market Approval

FDA Class 3 ·Adherus ET AutoSpray Dural Sealant, NUS-109

Agent, Absorbable Hemostatic, Non-Collagen Based

FDA Pre-Market Approval

FDA Class 3 ·SURGICEL Nu-Knit Absorbable Hemostat

Agent, Absorbable Hemostatic, Non-Collagen Based

FDA Pre-Market Approval

FDA Class 3 ·SURGICEL NU-KNIT Absorbable Hemostat

Agent, Absorbable Hemostatic, Non-Collagen Based

FDA Pre-Market Approval

FDA Class 3 ·Surgicel Nu-Knit Absorbable Hemostat

Agent, Absorbable Hemostatic, Non-Collagen Based

FDA Pre-Market Approval

FDA Class 3 ·SURGICEL*/SURGICEL NU-KNIT* ABSORBABLE HEMOSTAT

Agent, Absorbable Hemostatic, Non-Collagen Based

FDA Pre-Market Approval

FDA Class 3 ·SURGICEL*/SURGICEL NU-KNIT* ABSORBABLE HEMOSTAT

Prosthesis, Intervertebral Disc

FDA Pre-Market Approval

FDA Class 3 ·NU VASIVE PCM CERVICAL DISC SYSTEM

Agent, Absorbable Hemostatic, Non-Collagen Based

FDA Pre-Market Approval

FDA Class 3 ·SURGICEL*/SURGICEL NU-KNIT* ABSORBABLE HEMOSTAT

Agent, Absorbable Hemostatic, Non-Collagen Based

FDA Pre-Market Approval

FDA Class 3 ·SURGICEL, SURGICEL NU-KNIT FIBRILLAR ABSORBABLE HEMOSTAT

Agent, Absorbable Hemostatic, Non-Collagen Based

FDA Pre-Market Approval

FDA Class 3 ·SURGICEL/SURGICEL NU-KNIT/SURGICEL FIBRILLAR ABSORBABLE HEMOSTAT