REIGNING CROWN BRIDGE

FDA 510(k)

FDA Class 2 ·Dental

REIGNING REPAIR EPOXY RESIN

FDA 510(k)

FDA Class 2 ·Dental

REIGNING DENTURE MADE OF POLYCARB. RESIN

FDA 510(k)

FDA Class 2 ·Dental

REIGNING ARTIFICIAL TEETH/POLYCARB.RESIN

FDA 510(k)

FDA Class 2 ·Dental

REIGNING DENTURE

FDA 510(k)

FDA Class 2 ·Dental

MODIFICATION TO: OCU-FILM TIP COVER

FDA 510(k)

FDA Class 2 ·Ophthalmic

Topwide Surgical Face Mask

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Hyper Insight - ICH

FDA 510(k)

FDA Class 2 ·Radiology

OCU-FLEX 55 SPHERICAL, TORIC,THIN ZONE TORIC,ASPHERICAL,TORIC ASPHERICAL AND THIN ZONE TORIC ASPHERICAL (METHAFILCON A)S

FDA 510(k)

FDA Class 2 ·Ophthalmic

OCU-FLEX-49 SPHERICAL, TORIC, ASPHERICAL AND TORIC ASPHERICAL (HIOXIFILCON B) SOFT CONTACT LENSES FOR DAILY WEAR

FDA 510(k)

FDA Class 2 ·Ophthalmic

OCU-FLEX-38 KERATOCONUS (POLYMACON) SOFT CONTACT LENS FOR DAILY WEAR

FDA 510(k)

FDA Class 2 ·Ophthalmic

OCU-FLEX-53 THIN ZONE TORIC AND THIN ZONE TORIC ASPHERICAL (OCUFILCON) SOFT CONTACT LENSES FOR DAILY WEAR

FDA 510(k)

FDA Class 2 ·Ophthalmic

OCU-FLEX-49 THIN ZONE TORIC AND THIN Z0NE TORIC ASPHERICAL (HIOXIFILCON B) SOFT CONTACT LENSES FOR DAILY WEAR (LATHE-CUT

FDA 510(k)

FDA Class 2 ·Ophthalmic

OCU-FLEX PEDIATRIC APHAKIC (OCUFILCON B) SPHERICAL SOFT CONTACT LENS FOR DAILY WEAR (LATHE-CUT)

FDA 510(k)

FDA Class 2 ·Ophthalmic

OCU-FLEX-53 CUSTOM PROSTHETIC (OCUFILCON B) SOFT CONTACT LENS

FDA 510(k)

FDA Class 2 ·Ophthalmic

TINTED OCU-FLEX 53 (OCCUFILCON B) SOFT HYDROPHILIC CONTACT LENS

FDA 510(k)

FDA Class 2 ·Ophthalmic

WAKO LBA DCP TEST SYSTEM, MODEL 993-05301; DCP CONTROL SET, MODEL 995-0551; DCP CALIBRATOR SET, LIBASYS, MODEL 999-05401

FDA 510(k)

FDA Class 2 ·Immunology

REPROCESSED BALOON INFLATION DEVICE

FDA 510(k)

FDA Class 2 ·Cardiovascular

CDR SYSTEMS PRECISION PATIENT POSITIONING SYSTEM

FDA 510(k)

FDA Class 2 ·Radiology

ORTHO-MUNE OKB (CD19)- MONOCLONAL ANTIBODY (MURINE) PHYCOERYTHRINE CONJUGATE

FDA 510(k)

FDA Class 2 ·Hematology