Bone Sonometer

FDA Pre-Market Approval

FDA Class 2 ·DTU-ONE ULTRASOUND SCANNER

RAPID GENOTYPING ASSAY -CYP2C9 & VKORC1, MODEL CATALOG NO. 006+0203 GACTGA

FDA 510(k)

FDA Class 2 ·Hematology

EpiFaith Syringe (Luer Slip) , EpiFaith Syringe (NRFit)

FDA 510(k)

FDA Class 2 ·General Hospital

GUIDEWIRES

FDA 510(k)

FDA Class 2 ·Cardiovascular

EMBRYON SINGLE AND DOUBLE LUMEN NEEDLES

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

ULTRA-FINE DIATHERMY LOOP AND COAGULATION BALLS

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

ROCKET PLEURASEAL II CHEST DRAINAGE SYSTEM

FDA 510(k)

FDA Class 2 ·General Hospital

HYSTALOG HSG CATHETER

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

Avantgarde Faecal Management Systems, Avantgarde Faecal Management System Replacement Pouches

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

CRAFT DUO-VAC SUCTION UNIT AND CRAFT SUCTION UNIT

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

EMBRYON TRANSFER CATHETERS/SETS

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

URIGLOW TRANSILLUMINATING URETERIC STENT MODEL

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

NEUROTHERM RF CANNULA

FDA 510(k)

FDA Class 2 ·Neurology

EMBRYON GIFT TRANSFER CATHETERS/SETS

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

System, Test, Carcinoembryonic Antigen

FDA Pre-Market Approval

FDA Class 2 ·ABBOTT CEA-EIA ONE-STEP

Anovo Surgical System (Model 6Ne); Anovo Instrument ARM Curved Scissors ; Anovo Instrument ARM Hook Electrode

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

VACUETTE VISIO PLUS BLOOD COLLECTION NEEDLES

FDA 510(k)

FDA Class 2 ·General Hospital

TRUSTEX FLAVOR CONDON IN COLORS

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

VACUETTE QUICKSHIELD WITH SNAPPY TUBE HOLDER

FDA 510(k)

FDA Class 2 ·General Hospital

MINICOLLECT CAPILLARY BLOOD COLLECTION TUBES

FDA 510(k)

FDA Class 2 ·Clinical Chemistry