Catheter, Sampling, Chorionic Villus

FDA Pre-Market Approval

FDA Class 3 ·TROPHOCAN TM CHORIONIC VILLUS SAMPLING CATHETER

Catheter, Sampling, Chorionic Villus

FDA Pre-Market Approval

FDA Class 3 ·TROPHOCAN TM

Catheter, Sampling, Chorionic Villus

FDA Pre-Market Approval

FDA Class 3 ·TROPHOCAN TM CHORIONIC VILLUS SAMPLING CATHETER

Catheter, Sampling, Chorionic Villus

FDA Pre-Market Approval

FDA Class 3 ·TROPHOCAN TM

Catheter, Sampling, Chorionic Villus

FDA Pre-Market Approval

FDA Class 3 ·TROPHOCAN TM CHORIONIC VILLUS SAMPLING CATHETER

Catheter, Sampling, Chorionic Villus

FDA Pre-Market Approval

FDA Class 3 ·TROPHOCAN TM CHORIONIC VILLUS SAMPLING CATHETER

MULTI-FUNCTION DEFIBRILLATION ELECTRODE

FDA 510(k)

FDA Class 3 ·Cardiovascular

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval

FDA Class 3 ·Siello T/JT, Solia T/JT, Siello S, Solia S, Evia DR, Evia DR-T, Evia SR, Entovis DR, Entovis DR-T, Entovis SR, Entovis S

Prosthesis, Spinous Process Spacer/Plate

FDA Pre-Market Approval

FDA Class 3 ·Superion Indirect Decompression System

Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

FDA Pre-Market Approval

FDA Class 3 ·Saluda Medical Evoke SCS System

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·DEXTRUS, SELOX ST/JT, SETROX S, AND TILDA T/JT/R STEROID-ELUTING PACING LEADS; SOLOX SLX -BP PACING LEAD

Pump, Infusion, Implanted, Programmable

FDA Pre-Market Approval

FDA Class 3 ·ISOMED REFILL KIT/BULK REFILL KIT/ISOMED CAP KIT

Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

FDA Pre-Market Approval

FDA Class 3 ·PRECISION SPINAL CORD STIMULATOR (SCS) SYSTEM

Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

FDA Pre-Market Approval

FDA Class 3 ·Saluda Medical Evoke SCS System

Immunohistochemistry Assay, Antibody, Anaplastic Lymphoma Kinase

FDA Pre-Market Approval

FDA Class 3 ·VENTANA ALK (D5F3) CDX ASSAY

System, Test, Her-2/Neu, Ihc

FDA Pre-Market Approval

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

Immunohistochemistry Antibody Assay, C-Kit

FDA Pre-Market Approval

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

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

Somatic Gene Mutation Detection System

FDA Pre-Market Approval

FDA Class 3 ·Abbott RealTime IDH1 Assay

Pump, Infusion, Implanted, Programmable

FDA Pre-Market Approval

FDA Class 3 ·MEDSTREAM PROGRAMMABLE INFUSION SYSTEM CODMAN 3000 SERIES IMPLANTABLE INFUSION PUMP