INSTRUMENTATIONS UNLIMITED SYRINGE SYSTEM

FDA 510(k)

FDA Class 2 ·Dental

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·D114S/NEPTUNE X-ACT OVER-THE-WIRE BALLOON DILATATION CATHETER

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·NEPTUNE X-ACT OVER-THE-WIRE BALLOON DILATATION ACATHETER WITH HYDRO/PEL COATING AND ANTI BACK BLEED DEVICE

OLYMPUS CD-6C-1 COAGULATION ELECTRODE

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

STRATIFY JCV(TM) ANTIBODY

FDA 510(k)

FDA Class 2 ·Microbiology

STRATIFY JCV DXSELECT

FDA 510(k)

FDA Class 2 ·Microbiology

VivoSight Dx Topical OCT System

FDA 510(k)

FDA Class 2 ·Radiology

OPTIS Metallic Stent Optimization E.4 SW

FDA 510(k)

FDA Class 2 ·Radiology

OPXION Optical Skin Viewer (OPXSV1-01F)

FDA 510(k)

FDA Class 2 ·Radiology

Ilumien Optis, Optis Integrated, Optis Mobile

FDA 510(k)

FDA Class 2 ·Radiology

Starlight Imaging Catheter

FDA 510(k)

FDA Class 2 ·Radiology

OTIS Optical Coherence Tomography System

FDA 510(k)

FDA Class 2 ·Radiology

Cornaris Intravascular Imaging System (P80-E); Cornaris Intravascular Imaging System (Mobile-E); LumenCross Imaging Catheter (F2)

FDA 510(k)

FDA Class 2 ·Radiology

OPTIS Mobile System

FDA 510(k)

FDA Class 2 ·Radiology

NvisionVLE Imaging Console, NvisionVLE Marking Probe, 20mm balloon, NvisionVLE Marking Probe, 17mm balloon,NvisionVLE Marking Probe, 14mm balloon, NvisionVLE Inflation System

FDA 510(k)

FDA Class 2 ·Radiology

Gentuity HF-OCT Imaging System with Vis-Rx Micro-Imaging Catheter

FDA 510(k)

FDA Class 2 ·Radiology

NvisionVLE Imaging System, NvisionVLE Optical Probe, NvisionVLE Inflation System

FDA 510(k)

FDA Class 2 ·Radiology

OTIS Optical Coherence Tomography SYstem

FDA 510(k)

FDA Class 2 ·Radiology

ApolloVue S100 Image System

FDA 510(k)

FDA Class 2 ·Radiology

FORESEE (4C) IMAGING SYSTEM

FDA 510(k)

FDA Class 2 ·Radiology