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

JASON MARINE ALL TERRAIN ELECTRIC WHEELCHAIR, MODEL SEEKER II

FDA 510(k)

FDA Class 2 ·Physical Medicine

Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus

FDA Pre-Market Approval

FDA Class 2 ·ADVIA Centaur and Atellica IM HCV

Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus

FDA Pre-Market Approval

FDA Class 2 ·ARCHTECT ANTI-HCV

ALL SILICONE HEMATURIA CATHETER, MODELS 4861, 4862, 4863, 4864, 4865

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

APOLLO(TM) HIP SYST-STRAIGHT STEM/ALL-POLY ACET COMP

FDA 510(k)

FDA Class 2 ·Orthopedic

FSI LAPAROSCOPIC PROBE FOR ALL FSI ULE-OVERCLAD FF201 FIBERS

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

AXIOM TOTAL KNEE SYST, DUAL DOME ALL POLY TIB TRAY

FDA 510(k)

FDA Class 2 ·Orthopedic

ALL-SILICONE FOLEY BALLOON CATHETER (TWO WAY; THREE WAY, RADIOPAQUE)

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

REMEDY Stemmed Knee Spacer System with All-Poly Tibial Component

FDA 510(k)

FDA Class 2 ·Orthopedic

ALL-ETCH, ALL- ETCH WITH BAC; UNI- ETCH, UNI- ETCH WITH BAC; ETCH- 37, ETCH- 37 WITH BAC; DARK- ETCH, DARK ETCH (BLUE- E

FDA 510(k)

FDA Class 2 ·Dental

HISTOPLASMA YEAST ANTI #CF10021X

FDA 510(k)

FDA Class 2 ·Microbiology

FUNGAL IMMUNODIFFUSION KIT #ID1001

FDA 510(k)

FDA Class 2 ·Microbiology

HISTOPLASMA CAPSULATUM, ANTISERUM

FDA 510(k)

FDA Class 2 ·Microbiology

HISTOPLASMA YEAST ANTIGEN

FDA 510(k)

FDA Class 2 ·Microbiology