Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P)

FDA Pre-Market Approval

FDA Class 3 ·Sentus ProMRI OTW QP S-75, Sentus ProMRI OTW QP S-85, Sentus ProMRI OTW QP S-95, Sentus ProMRI OTW QP L-75, Sentus ProMR

Somatic Gene Mutation Detection System

FDA Pre-Market Approval

FDA Class 3 ·THXID BRAF KIT

Fluid, Intraocular

FDA Pre-Market Approval

FDA Class 3 ·ADATO SIL-OIL 5000 SILICONE OIL

Fluid, Intraocular

FDA Pre-Market Approval

FDA Class 3 ·ADATO SIL-OL 5000 SILICONE OIL SYRINGE

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval

FDA Class 3 ·VISTAKON (senofilcon A) Brand Contact Lenses

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·ICD AUTOGEN DR, ICD AUTOGEN VR, ICD DYNAGEN DR, ICD DYNAGEN VR, ICD INOGEN DR, ICD INOGEN VR, ICD ORIGEN DR, ICD ORIGEN

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

FDA Pre-Market Approval

FDA Class 3 ·ICD AUTOGEN CRT-D, ICD DYNAGEN CRT-D, ICD INOGEN CRT-D, ICD ORIGEN CRT-D, MOMENTUM CRT-D, MOMENTUM X4 CRT-D, RESONATE CR

Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P)

FDA Pre-Market Approval

FDA Class 3 ·PG VALITUDE CRT-P and PG VISIONIST CRT-P

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·PG ACCOLADE DR, PG ACCOLADE SR, PG ALTRUA 2 DR, PG ALTRUA 2 SR, PG ESSENTIO DR, PG ESSENTIO SR, PG PROPONENT DR, and PG

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·PG ACCOLADE MRI DR, PG ACCOLADE MRI SR, PG ESSENTIO MRI DR, PG ESSENTIO MRI SR, PG PROPONENT MRI DR, and PG PROPONENT M

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·IPure Preloaded IOL System

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·IPure Preloaded IOL System

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval

FDA Class 3 ·VISTAKON (senofilcon A) Brand Contact Lenses

Somatic Gene Mutation Detection System

FDA Pre-Market Approval

FDA Class 3 ·therascreen FGFR RGQ PCR Kit

Somatic Gene Mutation Detection System

FDA Pre-Market Approval

FDA Class 3 ·THERASCREEN EGFR RGQ PCR KIT

Somatic Gene Mutation Detection System

FDA Pre-Market Approval

FDA Class 3 ·THERASCREEN KRAS RGQ PCR KIT

Somatic Gene Mutation Detection System

FDA Pre-Market Approval

FDA Class 3 ·therascreen KRAS RGQ PCR Kit

Somatic Gene Mutation Detection System

FDA Pre-Market Approval

FDA Class 3 ·THERASCREEN EGFR RGQ PCR KIT

Somatic Gene Mutation Detection System

FDA Pre-Market Approval

FDA Class 3 ·therascreen EGFR RGQ PCR Kit

Somatic Gene Mutation Detection System

FDA Pre-Market Approval

FDA Class 3 ·therascreen PIK3CA RGQ PCR Kit