Assay,Enzyme Linked Immunosorbent,Parvovirus B19 Igm

FDA Pre-Market Approval

FDA Class 3 ·BIOTRIN PARVOVIRUS B19 IGM ENZYME IMMUNOASSAY

Ventricular (Assist) Bypass

FDA Pre-Market Approval

FDA Class 3 ·ABIOMED(R) BVS 5000 BI-VENTRICULAR SUPPORT SYSTEM

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

FDA Pre-Market Approval

FDA Class 3 ·FoundationOne CDx Assay

Cancer-Related Germline Gene Mutation Detection System

FDA Pre-Market Approval

FDA Class 3 ·myChoice HRD CDx

Cancer-Related Germline Gene Mutation Detection System

FDA Pre-Market Approval

FDA Class 3 ·myChoice HRD CDx

POWRPAK REPLACEMENT BATTERIES FOR PHISIO-CONTROL LIFEPAK 5/10

FDA 510(k)

FDA Class 3 ·Cardiovascular

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

FDA Pre-Market Approval

FDA Class 3 ·FoundationFocus CDx BRCA HRD

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

FDA Pre-Market Approval

FDA Class 3 ·myChoice CDx

Excimer Laser System

FDA Pre-Market Approval

FDA Class 3 ·MOBILEXCIMER FOR PTK AND PRK

Cancer-Related Germline Gene Mutation Detection System

FDA Pre-Market Approval

FDA Class 3 ·MyChoice CDx®

Cancer-Related Germline Gene Mutation Detection System

FDA Pre-Market Approval

FDA Class 3 ·BRACAnalysis CDx®

Excimer Laser System

FDA Pre-Market Approval

FDA Class 3 ·LASERVISION/VISX EXCIMER LASER FOR PRK AND PTK (MOBILEXCIMER)

System, Imaging, Fluorescence

FDA Pre-Market Approval

FDA Class 3 ·XILLIX-LIFE-LUNG

System, Imaging, Fluorescence

FDA Pre-Market Approval

FDA Class 3 ·PINPOINT ENDOSCOPIC LIGHT SOURCE AND VIDEO CAMERA

System, Imaging, Fluorescence

FDA Pre-Market Approval

FDA Class 3 ·PINPOINT ENDOSCOPIC LIGHT SOURCE AND VIDEO CAMERA

System, Imaging, Fluorescence

FDA Pre-Market Approval

FDA Class 3 ·KARL STORZ AUTOFLURESCENCE SYSTEM

System, Imaging, Fluorescence

FDA Pre-Market Approval

FDA Class 3 ·PINPOINT ENDOSCOPIC LIGHT SOURCE AND VIDEO CAMERA

System, Imaging, Fluorescence

FDA Pre-Market Approval

FDA Class 3 ·KARL STORZ AUTOFLUORESCENCE SYSTEM

System, Imaging, Fluorescence

FDA Pre-Market Approval

FDA Class 3 ·ONCO-LIFE ENDOSCOPIC LIGHT SOURCE AND VIDEO CAMERA (ONCO-LIFE)

System, Imaging, Fluorescence

FDA Pre-Market Approval

FDA Class 3 ·KARL STORZ AUTOFLUORESCENCE SYSTEM