CT Perfusion V1.0

FDA 510(k)

FDA Class 2 ·Radiology

MR DWI/FLAIR Measurement V1.0

FDA 510(k)

FDA Class 2 ·Radiology

Olea S.I.A. Neurovascular V1.0

FDA 510(k)

FDA Class 2 ·Radiology

Olea Sphere V3.0

FDA 510(k)

FDA Class 2 ·Radiology

Implantswiss Dental Implant System and Implantswiss Dental Abutment System

FDA 510(k)

FDA Class 2 ·Dental

CINA

FDA 510(k)

FDA Class 2 ·Radiology

RESPISENS

FDA 510(k)

FDA Class 2 ·Radiology

Sterispine™ PS

FDA 510(k)

FDA Class 2 ·Orthopedic

E>EyeC

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

VYSIS D7S486/CEP 7 FISH PROBE KIT

FDA 510(k)

FDA Class 2 ·Hematology

RHIGENE DSG-1 & DSG-3 ELISA TEST SYSTEM, MODEL 7680 E

FDA 510(k)

FDA Class 2 ·Immunology

KM-30 TENS ELECTRODE

FDA 510(k)

FDA Class 2 ·Neurology

ORTHORALIX E/GX-9000 PANORAMIC X-RAY SYSTEM

FDA 510(k)

FDA Class 2 ·Dental

PROCESSOR, RADIOGRAPHIC-FILM, AUTOMATIC, DENTAL

FDA 510(k)

FDA Class 2 ·Radiology

RHIGENE MESACUP-2 TEST RNP, MODEL M7741

FDA 510(k)

FDA Class 2 ·Immunology

EyeYon (hioxirilcon D) Soft (hydrophillc) ContactLensesfor Daily Wear, Hyper-CL (hioxirilcon D)TherapeuticSoft (hydrophillc) Contact Lensesfor Daily Wear

FDA 510(k)

FDA Class 2 ·Ophthalmic

K-DEFIB/PACE ADULT ELECTRODE, MODEL KDP-85

FDA 510(k)

FDA Class 2 ·Cardiovascular

DIGITRON 3, LV ANALYSIS PROTCOL

FDA 510(k)

FDA Class 2 ·Radiology

SPS-1TM STATIC PRESERVATION SOLUTION, MODELS SPS-1-500 ML, SPS 1-1L, SPS-1-2L

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

RHIGENE HEP-ANA TEST SYSTEM

FDA 510(k)

FDA Class 2 ·Immunology