FORTUNE ALL SILICONE STOMACH (GASTRIC) TUBES, MODEL 2020

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Paradigm All-Suture Anchor 1.8mm, White/Black #2

FDA 510(k)

FDA Class 2 ·Orthopedic

NeuroStar Advanced Therapy System (All previously cleared models)

FDA 510(k)

FDA Class 2 ·Neurology

SAUFLON ALL-IN-ONE LIGHT CONTACT LENS SOLUTION

FDA 510(k)

FDA Class 2 ·Ophthalmic

Freedom Total Knee System (All-poly Tibial Plate)

FDA 510(k)

FDA Class 2 ·Orthopedic

Vis-U-All Low Temperature Sterilization Pouch/Tubing

FDA 510(k)

FDA Class 2 ·General Hospital

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·LEOCOR SABLE(TM) PTCA CATHETER

Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus

FDA Pre-Market Approval

FDA Class 2 ·ELECSYS ANTI-HCV IMMUNOASSAY

Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus

FDA Pre-Market Approval

FDA Class 2 ·ELECSYS ANTI-HCV IMMUNOASSAY

Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus

FDA Pre-Market Approval

FDA Class 2 ·ELECSYS ANTI-HCV IMMUNOASSAY

PCA MODULAR TOTAL KNEE SYS-ALL PLAS PATELLAR COMP

FDA 510(k)

FDA Class 2 ·Orthopedic

Currie Medical ALP Pediatric Calf Compression Sleeves (all sizes)

FDA 510(k)

FDA Class 2 ·Cardiovascular

Well Lead All Silicone Foley Catheter with Temperature Sensor

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

P.F.C.(R) MODULAR KNEE SYST, STAB ALL-PLAST TIBIAL

FDA 510(k)

FDA Class 2 ·Orthopedic

ORTHOLOC ADVANTIM LSI POSTERIOR STABLIZED ALL POLYTHYLENE TIBIAL COMPONENT

FDA 510(k)

FDA Class 2 ·Orthopedic

VIS-U-ALL II HEAT-SEAL POUCH AND TUBING

FDA 510(k)

FDA Class 2 ·General Hospital

TRITANIUM NON-MODULAR SHELL & X3 ALL-POLY INSERT

FDA 510(k)

FDA Class 2 ·Orthopedic

Responsive Arthroscopy Stealth and Mini Stealth All-Suture Anchors

FDA 510(k)

FDA Class 2 ·Orthopedic

OPC 3G ALL-CERAMIC SYSTEM, CORE AND OVERLAY PORCELAINS

FDA 510(k)

FDA Class 2 ·Dental

MODIFICATION TO ATB ALL-TERRAIN BALLOON PTA DILATATION CATHETER

FDA 510(k)

FDA Class 2 ·Cardiovascular