BN-74 COATED BARDEX ALL SILICONE CATH

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

EZ LOAD MODEL 30, ALL LEVEL COT

FDA 510(k)

FDA Class 2 ·General Hospital

MicroLink All-Suture Button Fixation System (Radiolucent)

FDA 510(k)

FDA Class 2 ·Orthopedic

All’InCath 035M PTA Balloon Dilatation Catheter

FDA 510(k)

FDA Class 2 ·Cardiovascular

MOSS TUBES, INC, ALL SILICONE GASTROSTOMY TUBE

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Y-KNOT ALL-SUTURE ANCHOR MODEL HF13

FDA 510(k)

FDA Class 2 ·Orthopedic

ORION ALL SILICONE FOLEY CATHETER TEMPERATURE PROBE

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

ODOR MASKING AGENT FOR CONTENTS OF ALL

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

MODI. DICOR CASTABLE CERAMIC/ALL PORCELAIN BRIDGES

FDA 510(k)

FDA Class 2 ·Dental

All-Bond Universal w/BAC (not finalized)

FDA 510(k)

FDA Class 2 ·Dental

EdgeFlow UH10

FDA 510(k)

FDA Class 2 ·Radiology

HEARTSCAN SOFTWARE

FDA 510(k)

FDA Class 2 ·Radiology

DenQ Sub SLA Implant System

FDA 510(k)

FDA Class 2 ·Dental

Platinum dRF Imaging System

FDA 510(k)

FDA Class 2 ·Radiology

WARD-CSS (v1.2.x)

FDA 510(k)

FDA Class 2 ·Cardiovascular

BOOMERANG ABSORPTION COMENSATION FILTER

FDA 510(k)

FDA Class 2 ·Radiology

DERMATRON SKIN RESISTANCE METER

FDA 510(k)

FDA Class 2 ·Neurology

Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus

FDA Pre-Market Approval

FDA Class 2 ·ARCHITECT ANTI-HCV

VERIFY All-In-One STEAM Reusable Test Pack, VERIFY All-In-One STEAM Reusable Test Pack with Step Counter, VERIFY All-In-One STEAM Reusable Test Pack with Tracker Tag

FDA 510(k)

FDA Class 2 ·General Hospital

VERIFY All-In-One STEAM Reusable Test Pack, VERIFY All-In-One STEAM Reusable Test Pack with Step Counter, VERIFY All-In-One STEAM Reusable Test Pack with Tracker Tag

FDA 510(k)

FDA Class 2 ·General Hospital