Uro-G HD Cystoscope (1520)

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Uro-G HD Flexible Cystoscope

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

CHEMSTRIP L

FDA 510(k)

FDA Class 1 ·Hematology

NAPHTHOL AS-D CHLOR/A-NAPHTHYL ACET ESTERASE KIT

FDA 510(k)

FDA Class 1 ·Hematology

NITRO BLUE TETRAZOLIUM REDUCTION

FDA 510(k)

FDA Class 1 ·Hematology

ALKALINE PHOSPHATASE, LEUKOCYTE, KIT

FDA 510(k)

FDA Class 1 ·Hematology

HP-3 HD ELECTRIC WHEELCHAIR

FDA 510(k)

FDA Class 2 ·Physical Medicine

KRONUS GAD AUTOANTIBODY ELISA ASSAY KIT

FDA 510(k)

FDA Class 2 ·Immunology

KRONUS GLUTAMIC ACID DECARBOXYLASE ANTIBODY KIT

FDA 510(k)

FDA Class 2 ·Immunology

OptiCross, OptiCross HD, OptiCross 6, OptiCross 6 HD

FDA 510(k)

FDA Class 2 ·Cardiovascular

OptiCross 6 HD, 60 MHz Coronary Imaging Catheter (Paper DFU), OptiCross 6 HD, 60 MHz Coronary Imaging Catheter (e-DFU)

FDA 510(k)

FDA Class 2 ·Cardiovascular

OptiCrossTM HD Coronary Imaging Catheter, OptiCrossTM 6 HD Coronary Imaging Catheter

FDA 510(k)

FDA Class 2 ·Cardiovascular

Axial3D Cloud Segmentation Service

FDA 510(k)

FDA Class 2 ·Radiology

Axial3D Cloud Segmentation Service

FDA 510(k)

FDA Class 2 ·Radiology

POLY-TAPES WITH THE FASTLOK FIXATION DEVICE

FDA 510(k)

FDA Class 2 ·Orthopedic

THE GRAFTOLOGER

FDA 510(k)

FDA Class 1 ·General, Plastic Surgery

Axial3D Insight

FDA 510(k)

FDA Class 2 ·Radiology

POLY-TAPES (VARIOUS SIZES AND WOVEN CONSTRUCTION VARIANTS)

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Axial3D Insight

FDA 510(k)

FDA Class 2 ·Radiology

REAMER BIT

FDA 510(k)

FDA Class 1 ·Orthopedic