0909FCC, 0909FCC-HS

FDA 510(k)

FDA Class 2 ·Radiology

1717SCV, 1717SGV

FDA 510(k)

FDA Class 2 ·Radiology

Unispace SA Cervical Cage

FDA 510(k)

FDA Class 2 ·Orthopedic

Xmaru View V1 and Xmaru PACS, Medical Image Processing Software

FDA 510(k)

FDA Class 2 ·Radiology

I-CHROMA IFOB WITH I-CHROMA READER

FDA 510(k)

FDA Class 2 ·Hematology

Jeesung Safety Syringe and Single Use Needles

FDA 510(k)

FDA Class 2 ·General Hospital

EzRay Air 2 Wall (Model: VEX-S350W)

FDA 510(k)

FDA Class 2 ·Dental

Green16/Green18 (Model: PHT-65LHS)

FDA 510(k)

FDA Class 2 ·Radiology

FRAXIS DUO

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

ASPIRON ACP SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

STERI-OSS Implant System

FDA 510(k)

FDA Class 2 ·Dental

Velofix™ SA Cervical Cage

FDA 510(k)

FDA Class 2 ·Orthopedic

Calcium Salt Bone Void Filler, Drillable, Non-Screw Augmentation

FDA Pre-Market Approval

FDA Class 2 ·PRO OSTEON IMPLANT 500 HYDROXYAPATITE BONE VOID FILLER

Powered Breast Pump (Models 7V and 7X)

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

NubeX

FDA 510(k)

FDA Class 2 ·Radiology

INNO SLA Submerged Implant System

FDA 510(k)

FDA Class 2 ·Dental

SKORE Smooth Condoms - SKORE Colors & Flavors, SKORE Smooth Condoms - SKORE Vanilla

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

Assure Prism multi Blood Glucose Monitoring System

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

Huvitz Imaging System

FDA 510(k)

FDA Class 2 ·Radiology

ReliOn Premier Classic Blood Glucose Monitoring System

FDA 510(k)

FDA Class 2 ·Clinical Chemistry