DirectView 2 Mirror

FDA UDI

Ion Vision, Inc·00850054345226·

DirectView Suture Lysis

FDA UDI

Ion Vision, Inc·00850054345325·

Ion Coagulation Pen

FDA UDI

ION MEDICAL, INC.·B9122023102·23 Gauge Fine Point Bipolar Coagulation Pen

eZView 124 SP

FDA UDI

Ion Vision, Inc·00850054345141·

i3D Elite Stereo1x

FDA UDI

Ion Vision, Inc·00850054345479·

i3D Elite StereoMag

FDA UDI

Ion Vision, Inc·00850054345462·

Ion Coagulation Pen

FDA UDI

ION MEDICAL, INC.·B9122023152·20-23 Gauge Fine Point Bipolar Coagulation Pen

SurgiView Direct .75

FDA UDI

Ion Vision, Inc·00850054345356·

DirectView 1 Mirror SLT Flange

FDA UDI

Ion Vision, Inc·00850054345394·

i3D WideField

FDA UDI

Ion Vision, Inc·00850054345417·

eZView 22D

FDA UDI

Ion Vision, Inc·00850054345158·

eZView 28D

FDA UDI

Ion Vision, Inc·00850054345080·

DirectView 4 Mirror NF w/ Handle

FDA UDI

Ion Vision, Inc·00850054345493·

Immunohistochemistry Assay, Antibody, Ki-67

FDA Pre-Market Approval

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

Immunohistochemistry Assay, Antibody, Programmed Death-Ligand 1

FDA Pre-Market Approval

FDA Class 3 ·PD-L1 IHC 28-8 PHARMDX (Melanoma Indication)

Immunohistochemistry Assay, Antibody, Ki-67

FDA Pre-Market Approval

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

Immunohistochemistry Assay, Antibody, Programmed Death-Ligand 1

FDA Pre-Market Approval

FDA Class 3 ·PD-L1 IHC 28-8 PHARMDX (MELANOMA INDICATION)

LATEX EXAMINATION GLOVE POWDER FREE

FDA 510(k)

FDA Class 1 ·General Hospital

IOULIA AND IRENE TSETI PHARMACEUTICAL LABORATORIES S.A.

Manufacturer

45 Basic UDI-DIs·45 Devices·HTCert (Health Technology Certification Ltd), HTCert (Health Technology Certification Ltd), NATIONAL EVALUATION CENTER OF QUALITY AND TECHNOLOGY IN HEALTH S.A.- EKAPTY, NATIONAL EVALUATION CENTER OF QUALITY AND TECHNOLOGY IN HEALTH S.A.- EKAPTY, 3EC International a.s., 3EC International a.s., 3EC International a.s., 3EC International a.s., 3EC International a.s., 3EC International a.s., 3EC International a.s., 3EC International a.s., and 3EC International a.s.

NSS-2 System

FDA 510(k)

FDA Class 2 ·Neurology