Pantheris SV system

FDA registration

AVINGER, INC.·2 products·🇺🇸 United States

Isomedix Operations Inc.

FDA registration

Isomedix Operations Inc.·2 products·🇺🇸 United States

ILUMIEN OPTIS, OPTIS Integrated, OPTIS Mobile with AptiVue Software version E.5.2

FDA registration

Abbott Medical·2 products·🇺🇸 United States

ILUMIEN System and Accessories with Dragonfly OPTIS Imaging Catheter

FDA registration

ABBOTT VASCULAR·2 products·🇺🇸 United States

Vis-Rx® Micro-Imaging Catheter

FDA registration

GENTUITY, LLC·2 products·🇺🇸 United States

Isomedix Operations, Inc.

FDA registration

Isomedix Operations, Inc.·2 products·🇺🇸 United States

ILUMIEN Systems with AptiVue Software Version D.3

FDA registration

ABBOTT VASCULAR·2 products·🇺🇸 United States

PLASMAJET SYSTEM

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

ManaMed Inc

FDA UDI

MANAMED INC·00810113682532·ManaEZ Ice Wrap Shoulder is a quick fitting, un...

ManaMed

FDA UDI

MANAMED INC·00810113680675·The ManaEZ Shoulder ice a convenient shoulder o...

Optis Mobile Next Imaging System

FDA registration

ABBOTT VASCULAR·3 products·🇺🇸 United States

Novasight Hybrid System

FDA registration

Conavi Medical Inc·3 products·🇨🇦 Canada

Optis Mobile Next Imaging System

FDA registration

Abbott Medical·3 products·🇺🇸 United States

Immunohistochemistry Assay, Antibody, Ki-67

FDA Pre-Market Approval

FDA Class 3 ·Ki-67 IHC pharmDx

Normothermic Machine Perfusion System For The Preservation Of Donor Livers Prior To Transplantation

FDA Pre-Market Approval

FDA Class 3 ·Organ Care System (OCS™) Liver

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

FDA Pre-Market Approval

FDA Class 3 ·AAV5 DetectCDx®

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

FDA Pre-Market Approval

FDA Class 3 ·AAV5 DetectCDx

Normothermic Machine Perfusion System For The Preservation Of Donor Livers Prior To Transplantation

FDA Pre-Market Approval

FDA Class 3 ·OrganOx metra® System

Normothermic Machine Perfusion System For The Preservation Of Donor Livers Prior To Transplantation

FDA Pre-Market Approval

FDA Class 3 ·OrganOx metra System

Immunohistochemistry Assay, Antibody, Ki-67

FDA Pre-Market Approval

FDA Class 3 ·Ki-67 IHC MIB-1 pharmDx (Dako Omnis)