Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·CHANGES TO ACS(R) RX STREAK(TM).014 & .010 CATH.

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·PYROGEN TESTING OF ACS/CORNARY DILATATION CATHETERS E-BEAM- RADIATION STERILIZER

VITROS Chemistry Products HbA 1c Reagent Kit, VITROS Calibrator Kit 31, VITROS Chemistry Products %A1c Performance Verifiers I and II

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

COHERENT FUNDUSL RETINAL CAMERA

FDA 510(k)

FDA Class 2 ·Ophthalmic

AO DOCUSTAR(MMIRO) FUNDUS CAMERA

FDA 510(k)

FDA Class 2 ·Ophthalmic

OPTOMED SMARTSCOPE M5 EY3 AND M5 ES1

FDA 510(k)

FDA Class 2 ·Ophthalmic

TRC-NW300 NON-MYDRIATIC RETINAL CAMERA

FDA 510(k)

FDA Class 2 ·Ophthalmic

TOMEY PE-300 PORTABLE ERG

FDA 510(k)

FDA Class 2 ·Ophthalmic

XyCAM RI, XyCAM RI System, XyCAM Retinal Imaging System

FDA 510(k)

FDA Class 2 ·Ophthalmic

LIPIVIEW OCULAR SURFACE INTERFEROMETER

FDA 510(k)

FDA Class 2 ·Ophthalmic

KOWA VX-20

FDA 510(k)

FDA Class 2 ·Ophthalmic

HT-WEDGE

FDA 510(k)

FDA Class 2 ·General Hospital

Optina-4C (MHRC-C1N)

FDA 510(k)

FDA Class 2 ·Ophthalmic

PANORAMIC LOUPES - VARIOUS

FDA 510(k)

FDA Class 2 ·Ophthalmic

KONAN NONCON ROBO PACHY SPECULAR MICROSCOPE AND OPTICL PACHYMETER

FDA 510(k)

FDA Class 2 ·Ophthalmic

KOWA GENESIS-D

FDA 510(k)

FDA Class 2 ·Ophthalmic

CF-1

FDA 510(k)

FDA Class 2 ·Ophthalmic

DIGITAL RETINAL CAMERA

FDA 510(k)

FDA Class 2 ·Ophthalmic

ORION

FDA 510(k)

FDA Class 2 ·Ophthalmic

LipiView II Ocular Surface Interferometer

FDA 510(k)

FDA Class 2 ·Ophthalmic