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

Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)

FDA Pre-Market Approval

FDA Class 3 ·ADVIA Centaur Anti-HBc Total 2 (HBcT2), ADVIA Centaur® HBcT2 Quality Control (HBcT2 QC)

UFI GEL HARD

FDA 510(k)

FDA Class 2 ·Dental

Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)

FDA Pre-Market Approval

FDA Class 3 ·Atellica IM Hepatitis B core IgM (aHBcM) assay; Atellica IM Hepatitis B core lgM Quality Control (aHBcM QC)

Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus

FDA Pre-Market Approval

FDA Class 2 ·ADVIA Centaur HCV ReadyPack Reagents, Atellica IM Hepatitis C (aHCV), Atellica IM Hepatitis C Quality Control(aHCV QC)

Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)

FDA Pre-Market Approval

FDA Class 3 ·Atellica IM Anti-Hepatitis B core Total (HBcT), Atellica IM Anti-Hepatitis B core Total Quality Control (HBcT QC)

EVA Vitrectomy Pack VGPC Input 20G

FDA UDI

D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.·08717872034652·

EVA Vitrectomy Pack VGPC Input 20G

FDA UDI

D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.·08717872030678·

EVA NEXUS™, Phaco vitrectomy system including laser with SMA connector

FDA UDI

D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.·08717872034447·