Prostrate Cancer Genes Nucleic Acid Amplification Test System

FDA Pre-Market Approval

FDA Class 3 ·PROGENSA PCA3 ASSAY

Opioid Use Disorder Genetic Risk Variant Detection System And Collection Kit

FDA Pre-Market Approval

FDA Class 3 ·AvertD and AvertD Buccal Sample Collection Kit

Immunohistochemistry Assay, Antibody, Met

FDA Pre-Market Approval

FDA Class 3 ·VENTANA MET (SP44) RxDx Assay

Excimer Laser System

FDA Pre-Market Approval

FDA Class 3 ·STAR S4 IR EXCIMER LASER SYSTEM WITH VARIABLE SPOT SCANNING (VSS)

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

FDA Pre-Market Approval

FDA Class 3 ·ELECSYS ANTI-HBC IMMUNOASSAY, ELECSYS PRECICONTROL ANTI-HBC FOR USE ON THE ELECSYS 2010 IMMUNOASSAY ANALYZER

Immunohistochemistry Assay, Antibody, Claudin 18

FDA Pre-Market Approval

FDA Class 3 ·VENTANA CLDN18 (43-14A) RxDx Assay

Immunohistochemistry Assay, Antibody, Folr1

FDA Pre-Market Approval

FDA Class 3 ·VENTANA FOLR1 (FOLR-2.1) RxDx Assay

Excimer Laser System

FDA Pre-Market Approval

FDA Class 3 ·VISX EXCIMER LASER SYSTEM MODELS B AND C

Agent, Absorbable Hemostatic, Collagen Based

FDA Pre-Market Approval

FDA Class 3 ·GELFOAM STERILE SPONGE

Excimer Laser System

FDA Pre-Market Approval

FDA Class 3 ·VISX STAR S4 IR EXCIMER LASER SYSTEM

Programmer, Pacemaker

FDA Pre-Market Approval

FDA Class 3 ·VERITY ADX XL VDR MODEL 5456I PULSE GENERATOR

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval

FDA Class 3 ·VERITY ADX XL VDR MODEL 5456I PULSE GENERATOR

Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval

FDA Class 3 ·CHILLI COOLED ABLATION SYSTEM FOR THE CIRCUCOOL PUMP

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

FDA Pre-Market Approval

FDA Class 3 ·ELECSYS ANTI-HBC IMMUNOASSAY & ELECSYS PRECICONTROL ANTI-HBC

Sensor, Glucose, Invasive

FDA Pre-Market Approval

FDA Class 3 ·CARELINK PERSONAL SOFTWARE

Excimer Laser System

FDA Pre-Market Approval

FDA Class 3 ·TECHNOLAS 217A EXCIMER LASER SYSTEM

System, Test, Her-2/Neu, Ihc

FDA Pre-Market Approval

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

Automated External Defibrillators (Non-Wearable)

FDA Pre-Market Approval

FDA Class 3 ·X Series®, R Series®, AED Pro®, AED 3™ BLS Professional Defibrillators, Pro-Padz Radiotransparent Electrode, SurePower™

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·REVO MRI SURESCAN IPG AND PACING SYSTEM

Reader, Cervical Cytology Slide, Automated

FDA Pre-Market Approval

FDA Class 3 ·FOCALPOINT SYSTEMCREENING SYSTEM