Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·ADAPTA, VERSA, SENSIA IPG, ADVISA DR IPG, ADVISA DR MRI IPG, ENTHYTHM, KAPPA D (KAPPA 700) IPG & KAPA

Somatic Gene Mutation Detection System

FDA Pre-Market Approval

FDA Class 3 ·THERASCREEN KRAS RGQ PCR KIT

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

FDA Pre-Market Approval

FDA Class 3 ·CONSULTA CRT-P, SYNERA CRT-P

Normothermic Machine Perfusion System For The Preservation Of Donor Livers Prior To Transplantation

FDA Pre-Market Approval

FDA Class 3 ·Organ Care System (OCS™) Liver

Immunohistochemistry Assay, Antibody, Epidermal Growth Factor Receptor

FDA Pre-Market Approval

FDA Class 3 ·DAKO EGFR PHARMDX KIT

System, Colorectal Neoplasia, Rna Markers And Hemoglobin Detection

FDA Pre-Market Approval

FDA Class 3 ·ColoSense

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·REVO MRI IPG

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

FDA Pre-Market Approval

FDA Class 3 ·BRAVA CRT-D, CONCERTO ICD, CONCERTO II CRT-D, CONSULTA ICD, INSYNC II PROTECT ICD ,III MARQUIS ICD, INSYNC MAXIMO ICD,

Generator, Shock-Wave, For Pain Relief

FDA Pre-Market Approval

FDA Class 3 ·ORTHOSPEC EXTRACORPOREAL SHOCK WAVE THERAPY DEVICE

Somatic Gene Mutation Detection System

FDA Pre-Market Approval

FDA Class 3 ·COBAS 4800 BRAF V600 MUTATION TEST

Somatic Gene Mutation Detection System

FDA Pre-Market Approval

FDA Class 3 ·CRCDx RAS Mutation Detection Assay Kit

System, Test, Her-2/Neu, Nucleic Acid Or Serum

FDA Pre-Market Approval

FDA Class 3 ·DAKOCYTOMATION HER2 FISH PHARMDX KIT

Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)

FDA Pre-Market Approval

FDA Class 3 ·ABBOTT ARCHITECT CORE ASSAY

Automated External Defibrillators (Non-Wearable)

FDA Pre-Market Approval

FDA Class 3 ·Powerheart® AED G3 Pro

Prosthesis, Hip, Semi-Constrained, Ceramic-On-Metal Articulation

FDA Pre-Market Approval

FDA Class 3 ·PINNACLE COMPLETE ACETABULAR HIP SYSTEM

Next Generation Sequencing Oncology Panel, Somatic Or Germline Variant Detection System

FDA Pre-Market Approval

FDA Class 3 ·Praxis Extended RAS Panel

Kit, Test, Alpha-Fetoprotein For Neural Tube Defects

FDA Pre-Market Approval

FDA Class 3 ·ACCESS AFP IMMUNOASSAY SYSTEM

Sensor, Glucose, Invasive, Non-Adjunctive, Factory-Calibrated, User-Initiated

FDA Pre-Market Approval

FDA Class 3 ·Freestyle Libre Flash Glucose Monitoring System

Test, Prostate Specific Antigen, Free, (Noncomplexed) To Distinguish Prostate Cancer From Benign Conditions

FDA Pre-Market Approval

FDA Class 3 ·ABBOTT IMX FREE PSA

Temporary Non-Roller Type Left Heart Support Blood Pump

FDA Pre-Market Approval

FDA Class 3 ·IMPELLA 2.5 System