System, Test, Her-2/Neu, Ihc

FDA Pre-Market Approval

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

Chromogenic In Situ Hybridization, Nucleic Acid Amplification, Her2/Neu Gene, Breast Cancer

FDA Pre-Market Approval

FDA Class 3 ·INFORM HER-2 DUAL ISH DNA PROBE COCKTAIL

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

FDA Pre-Market Approval

FDA Class 3 ·Guardant360 CDx

Fluorescence In Situ Hybridization, Chromosome 17p Deletion (Tp53)

FDA Pre-Market Approval

FDA Class 3 ·Vysis CLL FISH Probe Kit

Aortic Valve, Prosthesis, Percutaneously Delivered

FDA classification

FDA Class 3 ·Aortic Valve, Prosthesis, Percutaneously Delivered

Analyzer, Oxyhemoglobin Concentration, Blood-Phase, Indwelling

FDA classification

FDA Class 3 ·Analyzer, Oxyhemoglobin Concentration, Blood-Phase, Indwelling

Prosthesis, Mitral Valve, Percutaneously Delivered

FDA classification

FDA Class 3 ·Prosthesis, Mitral Valve, Percutaneously Delivered

Percutaneously Delivered Prostheses And Tricuspid Valves

FDA classification

FDA Class 3 ·Percutaneously Delivered Prostheses And Tricuspid Valves

Assays To Detect Pre-Existing Antibodies To Adeno-Associated Virus (Aav) Viral Vectors

FDA classification

FDA Class 3 ·Assays To Detect Pre-Existing Antibodies To Adeno-Associated Virus (Aav) Viral Vectors

P.F.C. APICAL PLUG

FDA 510(k)

FDA Class 3 ·Orthopedic

COOK PACEMAKER 332T, SERIES R BIPOLAR CARDIAC PULS

FDA 510(k)

FDA Class 3 ·Cardiovascular

COOK PACEMAKER CORP. 332T BIPOLAR CARDIAC PULSE GE

FDA 510(k)

FDA Class 3 ·Cardiovascular

COOK PACEMAKER 33IT R UNIPOLAR CARDIAC PULSE GENER

FDA 510(k)

FDA Class 3 ·Cardiovascular

JOINT MEASUREMENT INDICATOR

FDA 510(k)

FDA Class 3 ·Orthopedic

MODEL 340 SERIES UNIPOLAR & MODEL 5000B PROGRAMMER

FDA 510(k)

FDA Class 3 ·Cardiovascular

samaritan PAD 450P

FDA 510(k)

FDA Class 3 ·Cardiovascular

MODEL 725TH HANDHELD TRANSCEIVER (PROGRAMMER)

FDA 510(k)

FDA Class 3 ·Cardiovascular

VISITHERM

FDA 510(k)

FDA Class 3 ·Obstetrics/Gynecology

REDUCED ENERGY PEDIATRIC ELECTRODE PADS FOR THE SAMARITAN AED AND PAD, MODELS SDE 251, SPP 351

FDA 510(k)

FDA Class 3 ·Cardiovascular

MODEL 327D, SERIES R UNIPOLAR CARDIAC PULSE GENER.

FDA 510(k)

FDA Class 3 ·Cardiovascular