PIVOTING COMPENSATING FILTERS FOR THE HEAD

FDA 510(k)

FDA Class 2 ·Radiology

DURETTE IMPLANT

FDA 510(k)

FDA Class 2 ·Ophthalmic

CALM

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

SILICONE SPHERES

FDA 510(k)

FDA Class 2 ·Ophthalmic

E-Z LINK

FDA 510(k)

FDA Class 2 ·General Hospital

INTER-VIAL

FDA 510(k)

FDA Class 2 ·General Hospital

THE PHARAOH COMPENSATING FILTER

FDA 510(k)

FDA Class 2 ·Radiology

VARIANT OF OCTOSTOP AND OCTOPAQUE

FDA 510(k)

FDA Class 1 ·Radiology

WRIST TRACTION

FDA 510(k)

FDA Class 2 ·Radiology

ACCESSORY TO UNIVERSAL OCTOPAQUE

FDA 510(k)

FDA Class 1 ·Radiology

OCTOSTOP(R) CHAIR (NEW MODEL

FDA 510(k)

FDA Class 2 ·Radiology

D. R. MEDICAL CONTROLLED PRESSURE GARMENTS

FDA 510(k)

FDA Class 2 ·General Hospital

DURETTE OCULAR IMPLANT

FDA 510(k)

FDA Class 2 ·Ophthalmic

ANTIFUNGAL QC LEVEL 1

FDA UDI

UTAK LABORATORIES, INC.·B800ANTIFQC1V2LPFTF0·ANTIFUNGAL QC LEVEL 1

ANTIFUNGAL QC LEVEL 2

FDA UDI

UTAK LABORATORIES, INC.·B800ANTIFQC2V2LPFTF0·ANTIFUNGAL QC LEVEL 2

ETG PLUS QC LEVEL 2 V2

FDA UDI

UTAK LABORATORIES, INC.·B800ETGQC2V2UFUCSF0·ETG PLUS QC LEVEL 2 V2

ETG PLUS QC LEVEL 1 V2

FDA UDI

UTAK LABORATORIES, INC.·B800ETGQC1V2UFUCSF0·ETG PLUS QC LEVEL 1 V2

Fluorescence In Situ Hybridization, Chromosome 17p Deletion (Tp53)

FDA Pre-Market Approval

FDA Class 3 ·Vysis CLL FISH Probe Kit

Fluorescence In Situ Hybridization, Anaplastic Lymphoma Kinase, Gene Rearrangement

FDA Pre-Market Approval

FDA Class 3 ·Vysis ALK Break Apart FISH Probe Kit

Kit, Rna Detection, Human Papillomavirus

FDA Pre-Market Approval

FDA Class 3 ·Aptima HPV Assay