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

FDA classification

FDA Class 3 ·Chromogenic In Situ Hybridization, Nucleic Acid Amplification, Her2/Neu Gene, Breast Cancer

Immunohistochemistry Assay, Antibody, Ki-67

FDA Pre-Market Approval

FDA Class 3 ·Ki-67 IHC pharmDx

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

System, Endovascular Graft, Aortic Aneurysm Treatment

FDA Pre-Market Approval

FDA Class 3 ·TRIVASCULAR, INC OVATION PRIME ABDOMINAL STENT GRAFT SYSTEM

Liver Iron Concentration Imaging Companion Diagnostic For Deferasirox

FDA classification

FDA Class 2 ·Liver Iron Concentration Imaging Companion Diagnostic For Deferasirox

HEMA.T MEDICAL

Importer

🇫🇷 France·3 Manufacturers

HemoSphere Alta Advanced Monitoring Platform

FDA registration

EDWARDS LIFESCIENCES LLC·9 products·🇺🇸 United States

HemoSphere Alta Advanced Monitoring Platform

FDA registration

BECTON, DICKINSON AND COMPANY·9 products·🇺🇸 United States

BENCHMARK ELECTRONICS, INC.

FDA registration

BENCHMARK ELECTRONICS, INC.·9 products·🇺🇸 United States

HemoSphere

FDA UDI

Edwards Lifesciences LLC·00690103197006·HemoSphere Advanced Monitor

HEMOSPHERE

FDA UDI

Edwards Lifesciences LLC·00690103199321·Pressure Cable

HEMOSPHERE FORESIGHT MODULE

FDA UDI

Edwards Lifesciences LLC·00690103208573·HEMOSPHERE FORESIGHT MODULE

HemoSphere

FDA UDI

Edwards Lifesciences LLC·00690103196993·HemoSphere Swan-Ganz Module

HemoSphere

FDA UDI

Edwards Lifesciences LLC·00690103202762·CLEARSIGHT MODULE

FORESIGHT OXIMETER CABLE

FDA UDI

Edwards Lifesciences LLC·00690103210927·FORESIGHT OXIMETER CABLE

HemoSphere Tissue Oximetry Module

FDA UDI

Edwards Lifesciences LLC·00690103200355·HemoSphere Tissue Oximetry Module

Comen

FDA UDI

Shenzhen Comen Medical Instruments Co., Ltd.·06945429055566·

HemoSphere

FDA UDI

Edwards Lifesciences LLC·00690103196986·HemoSphere Oximetry Cable

Device, Hemostasis, Vascular

FDA Pre-Market Approval

FDA Class 3 ·THE CLOSER AK 6 FR. SMC DEVICE

Kit, Rna Detection, Human Papillomavirus

FDA Pre-Market Approval

FDA Class 3 ·APTIMA HPV ASSAY