PARASCAN SCANNING DEVICE

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

SUB-Q SUBCUTANEOUS TISSUE INFUSION SET

FDA 510(k)

FDA Class 2 ·General Hospital

KIVA VCF TREATMENT SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

TWIN FIX

FDA 510(k)

FDA Class 2 ·Orthopedic

ONE STEP MARIJUANA CARD TEST

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

HEARTPORT ENDOVENOUS DRAINAGE CANNULA

FDA 510(k)

FDA Class 2 ·Cardiovascular

SYNCHRON SYSTEMS ALCOHOL (ALC) REAGENT, SYNCHRON SYSTEMS ALCOHOL CALIBRATOR

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

HEARTPORT DIRECT AORTIC RETURN CANNULA WITH INTRODUCER

FDA 510(k)

FDA Class 2 ·Cardiovascular

CLIPPER POWER DRIVE WHEELCHAIR

FDA 510(k)

FDA Class 2 ·Physical Medicine

ATRAUMAX(TM) SURGICAL CLAMPS

FDA 510(k)

FDA Class 2 ·Cardiovascular

DEPENDABOND

FDA 510(k)

FDA Class 2 ·Dental

DMRC Dual Cure Orthodontic Band Cement

FDA 510(k)

FDA Class 2 ·Dental

Solitaire Platinum Revascularization Device

FDA 510(k)

FDA Class 2 ·Cardiovascular

PixelShine

FDA 510(k)

FDA Class 2 ·Radiology

WORKSTATIONONE BREAST IMAGING WORKSTATION

FDA 510(k)

FDA Class 2 ·Radiology

Legacy2, Legacy3, Legacy4, simplyLegacy2, simplyLegacy3 dental implants; Legacy2, Legacy3, Legacy4 fixture-mounts

FDA 510(k)

FDA Class 2 ·Dental

SLEEP-IN BONE SCREW SYSTEM

FDA 510(k)

FDA Class 2 ·Dental

GMK - LINE EXTENSION

FDA 510(k)

FDA Class 2 ·Orthopedic

MONOCLONAL MOUSE ANTI-HUMAN T-CELL, CD8, RPE-CONJUGATED, CLONE DK25

FDA 510(k)

FDA Class 2 ·Hematology

CD3 FITC/CD4 R-PE MONOCLONAL ANTIBODY COMBINATION

FDA 510(k)

FDA Class 2 ·Hematology