MRI'S ALL SILICONE FOLEY CATHETER TEMPERATURE PROBE

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

All-in-One Health Monitor, PC-303

FDA 510(k)

FDA Class 2 ·Cardiovascular

ATB ALL-TERRAIN BALLOON PTA DILATATION CATHETER

FDA 510(k)

FDA Class 2 ·Cardiovascular

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

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

VIS-U-ALL LOW TEMPERATURE STERILIZATION POUCH/TUBING

FDA 510(k)

FDA Class 2 ·General Hospital

AXIOM TOTAL KNEE SYSTEM, ALL POLY TIBIAL TRAY

FDA 510(k)

FDA Class 2 ·Orthopedic

Vis-U-All Low Temperature Sterilization Pouch/Tubing

FDA 510(k)

FDA Class 2 ·General Hospital