Somatic Gene Mutation Detection System

FDA Pre-Market Approval

FDA Class 3 ·LeukoStrat CDx FLT3 Mutation Assay

SEA-BAND

FDA 510(k)

FDA Unclassified ·Unknown

EDWARDS AQUARIUS HEMOFILTRATION SYSTEM, MODEL ABM 01

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

SUMMIT MEDICAL LTD CELLTRANS POSTOPERATIVE AUTOTRANSFUSION SET, MODELS AB400-10, AB400-12, AB400-14

FDA 510(k)

FDA Class 2 ·Anesthesiology

SUMMIT MEDICAL LTD TRANSFUSION FILTER, MODEL LF400 & SUMMIT MEDICAL LTD TRANSFUSION FILTER WITH ADMINISTRATION SET

FDA 510(k)

FDA Class 2 ·General Hospital

I2S DOPPLER PROBE ( 6 HOUR), I2S DOPPLER PROBE (24 HOUR), I2C DOPPLER PROBE (72 HOUR), MODELS 9090-7015, 9090-7016

FDA 510(k)

FDA Class 2 ·Cardiovascular

NATRACAREN APPLICATOR TAMPON

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

DYNAMESH-PP STANDARD, MODEL PP02NNNN, DYNAMESH-PP LIGHT, MODEL PP01NNNN

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

KFH ENERGY, MODEL: E1

FDA 510(k)

FDA Class 2 ·Neurology

NATRACARE TAMPON

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

SUMMIT MEDICAL LTD CELLTRANS POSTOPERATIVE AUTOTRANSFUSION SYSTEM, MODELS ABT4510, ABT4512 & ABT4514

FDA 510(k)

FDA Class 2 ·Anesthesiology

EDWARDS AQUALINE STERILE TUBING SET; EDWARDS AQUALINS STERILE TUBING SET; EDWARDS AQUASPIKE AND AQUASAFE

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

ViewFinder Software Version 1.1

FDA 510(k)

FDA Class 2 ·Radiology

Immunohistochemistry Assay, Antibody, Anaplastic Lymphoma Kinase

FDA Pre-Market Approval

FDA Class 3 ·VENTANA ALK (D5F3) CDX ASSAY

Immunohistochemistry Assay, Antibody, Anaplastic Lymphoma Kinase

FDA Pre-Market Approval

FDA Class 3 ·VENTANA ALK (D5F3) CDX ASSAY

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

FDA Pre-Market Approval

FDA Class 3 ·FoundationOne Liquid CDx (F1LCDx)

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

FDA Pre-Market Approval

FDA Class 3 ·FoundationOne Liquid CDx (F1LCDx)

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

FDA Pre-Market Approval

FDA Class 3 ·FoundationOne Liquid CDx (F1LCDx)

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

FDA Pre-Market Approval

FDA Class 3 ·FoundationOne Liquid CDx (F1LCDx)

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

FDA Pre-Market Approval

FDA Class 3 ·FoundationOne®Liquid CDx