b-ONE MOBIO Total Knee System

FDA 510(k)

FDA Class 2 ·Orthopedic

b-ONE® Total Hip System

FDA 510(k)

FDA Class 2 ·Orthopedic

APEX MODULAR ACCTABULAR CUP (NOW NAMED APEX INTERFACE ACETABULAR SYSTEM)

FDA 510(k)

FDA Class 2 ·Orthopedic

MODIFICATION TO: BINAX NOW LEGIONELLA URINARY ANTIGEN TEST, #852-000,852-012

FDA 510(k)

FDA Class 2 ·Microbiology

BECKMAN VALPROIC ACID REAGENT

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

CMV IGM ANTIBODY TEST (INDIRECT FLUORESCENT TEST)

FDA 510(k)

FDA Class 2 ·Microbiology

HIGH PERFORMANCE TIPS

FDA 510(k)

FDA Class 2 ·Ophthalmic

VACUUM SURGE SUPRESSER

FDA 510(k)

FDA Class 2 ·Ophthalmic

COLORZYME NDNA TEST SYSTEM

FDA 510(k)

FDA Class 2 ·Immunology

BONART'S ARTEOTOMY OMI AND OPI ULTRASONIC SURGERY SYSTEM & ACCESSORIES

FDA 510(k)

FDA Class 2 ·Dental

BECKMAN ARRAY TOBRAMYCIN (TOB) REAGENT

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

LIFEMATE MLA MULTI-LINE ADAPTOR; LIFEMATE SFR STERILE FLUID RESERVOIR

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

BECKMAN IMMUNOGLOBULIN G (IGG) REAGENT, URINE APPLICATION, URINE PROTEIN CALIBRATOR, CONTROL

FDA 510(k)

FDA Class 2 ·Immunology

CMV IGG ANTIBODY TEST (INDIRECT FLUORESCENT TEST)

FDA 510(k)

FDA Class 2 ·Microbiology

I.D.-ZONE IMMUNOFIXATION ELECTROPHORESIS CONTROLS

FDA 510(k)

FDA Class 2 ·Immunology

COMFORTMATE FLUID WARMING SYSTEM, MODEL # FW-200; COMFORTMATE DISPORSABLE DISPOSABLE WARMING SET, MODEL #FWS-200

FDA 510(k)

FDA Class 2 ·General Hospital

SUTURE HANDLER

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

APOLIPOPROTEIN CALIBRATOR (APO-CAL)

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

FLUID ASPIRATION NEEDLE

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

BONART ULTRASONIC SCALER, MOEDLS ART-P3II PRO AND ART-MII PRO

FDA 510(k)

FDA Class 2 ·Dental