Implant, Dermal, For Aesthetic Use

FDA Pre-Market Approval

FDA Class 3 ·RHA 2, RHA 3, RHA 4

Mr-Guided Focused Ultrasound System

FDA Pre-Market Approval

FDA Class 3 ·Exablate Model 4000 Type 1.0 & Type 1.1 System (“Exablate Neuro”)

Sealant, Dural

FDA Pre-Market Approval

FDA Class 3 ·DURASEAL DURAL SEALANT SYSTEM

Implant, Dermal, For Aesthetic Use

FDA Pre-Market Approval

FDA Class 3 ·RHA® Redensity Mepi, RHA®2 Mepi, RHA®3 Mepi, RHA®4 Mepi

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

FDA Pre-Market Approval

FDA Class 3 ·INSYNC MARQUIS/SENTRY/MAXIMO/CONCERTO & VIRTUOSO CRT-ICDS

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·VARIOUS PAVEMAKERS, CARELINK MONITOR, CARDIOSIGHT READER

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·SELECTED FAMILIES OF PACEMAKERS

Implant, Dermal, For Aesthetic Use

FDA Pre-Market Approval

FDA Class 3 ·RHA®3 dermal filler

Immunohistochemistry Antibody Assay, C-Kit

FDA Pre-Market Approval

FDA Class 3 ·PATHWAY ANTI-C-KIT (9.7) RABBIT MONOCLONAL PRIMARY ANTIBODY

Antigen(Complexed),Prostate Specific,(Cpsa)

FDA Pre-Market Approval

FDA Class 3 ·ADVIA Centaur® and Atellica® IM AFP, ADVIA Centaur® and Atellica® IM PSA, ADVIA Centaur® and Atellica® IM cPSA

Immunohistochemistry Antibody Assay, C-Kit

FDA Pre-Market Approval

FDA Class 3 ·PATHWAY ANTI-C-KIT (9.7) REBBIT MONOCLONAL PRIMARY ANTIBODY

Antigen(Complexed),Prostate Specific,(Cpsa)

FDA Pre-Market Approval

FDA Class 3 ·Adiva Centaur Complexed PSA (cPSA) Immunoassay and Atellica IM cPSA Immunoassay

Immunohistochemistry Antibody Assay, C-Kit

FDA Pre-Market Approval

FDA Class 3 ·PATHWAY ANTI-C-KIT (9.7) RABBITT MONOCLONAL PRIMARY ANTOBODY

Immunohistochemistry Antibody Assay, C-Kit

FDA Pre-Market Approval

FDA Class 3 ·PATHWAY ANTI-C-KIT (9.7) PRIMARY ANTIBODY

Immunohistochemistry Antibody Assay, C-Kit

FDA Pre-Market Approval

FDA Class 3 ·DAKO C-KIT PHARMDX

Antigen(Complexed),Prostate Specific,(Cpsa)

FDA Pre-Market Approval

FDA Class 3 ·ADVIA Centaur and Atellica IM cPSA

Immunohistochemistry Assay, Antibody, Epidermal Growth Factor Receptor

FDA Pre-Market Approval

FDA Class 3 ·DAKOCYTOMATION EGFR PHARMDX

Immunohistochemistry Antibody Assay, C-Kit

FDA Pre-Market Approval

FDA Class 3 ·VENTANA PATHWAY ANTI-C-KIT PRIMARY ANTIBODY (POLYCLONAL)

Antigen(Complexed),Prostate Specific,(Cpsa)

FDA Pre-Market Approval

FDA Class 3 ·BAYER IMMUNO 1 COMPLEXED PSA ASSAY

Antigen(Complexed),Prostate Specific,(Cpsa)

FDA Pre-Market Approval

FDA Class 3 ·ADVIA CENTAUR CPSA ASSAY