VENTANA anti-MLH-1(M1) Mouse Monoclonal Primary Antibody, VENTANA anti-PMS2 (A16-4) Mouse Monoclonal Primary Antibody, VENTANA anti-MSH2 (G219-1129) Mouse Monoclonal Primary Antibody, VENTANA anti-MSH6 (SP 93) Mouse Monoclonal Primary Antibody, VENTANA anti-BRAF V600E (VE1) Mouse Monoclonal Primary Antibody

FDA 510(k)

FDA Class 2 ·Immunology

OncoMate MSI Dx Analysis System

FDA 510(k)

FDA Class 2 ·Immunology

Idylla MSI Test

FDA 510(k)

FDA Class 2 ·Immunology

BOND MMR Antibody Panel

FDA 510(k)

FDA Class 2 ·Immunology

Lynch Syndrome Test System

FDA classification

FDA Class 2 ·Lynch Syndrome Test System

MOTO PFJ System

FDA 510(k)

FDA Class 2 ·Orthopedic

STIMULATOR, NERVE, TRANSCUTANEOUS, (PAIN RELIEF) 84-GZJ

FDA 510(k)

FDA Class 2 ·Neurology

MOTOTM Partial Knee & MOTO PFJ Systems Extension

FDA 510(k)

FDA Class 2 ·Orthopedic

BNOS MICRO VENT, MODEL AC AND MODEL AO

FDA 510(k)

FDA Class 2 ·Anesthesiology

ENDOVIVE INITIAL PLACEMENT DIRECT PEJ KIT, MODELS 6520 & 6521

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

ENDOVIVE INITIAL PLACEMENT PEG KIT, DIRECT PEJ KIT, AND PEG SAFETY KIT

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

MODIFICATION TO ENDOVIVE INITIAL PLACEMENT PEG KIT, DIRECT PEJ KIT, PEG SAFETY KIT

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Firefighter™ NC Pro PTCA Balloon Catheter

FDA 510(k)

FDA Class 2 ·Cardiovascular

ENDOVIVE INITIAL PLACEMENT DIRECT PEJ KIT, ENDOVIVE STANDARD PROFILE BALLOON REPLACEMENT, MODELS 6520, 6521, 6220

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

EmbedMed

FDA 510(k)

FDA Class 2 ·Dental

MedCAD AccuPlan System

FDA 510(k)

FDA Class 2 ·Dental

SENSORMEDICS MODEL 2450 PULMONARY FUNCTION LAB.

FDA 510(k)

FDA Class 2 ·Dental

DETERM. SIZE 72 RADIAL-HUMAN IGD

FDA 510(k)

FDA Class 2 ·Immunology

ImmersiveView Surgical Plan (IVSP®)

FDA 510(k)

FDA Class 2 ·Dental

DigiGuide System

FDA 510(k)

FDA Class 2 ·Dental