MULTIPLE-LENS, SPECTACLES, CUSTOM

FDA 510(k)

FDA Class 2 ·Ophthalmic

PEDRA-17F Digital Flat Panel X-ray Detector

FDA 510(k)

FDA Class 2 ·Radiology

CD3 FITC/CD8 R-PE/CD45 TRI-COLOR MONOCLONAL ANTIBODY COMBINATION

FDA 510(k)

FDA Class 2 ·Hematology

ETII SA FIXTURE SYSTEM

FDA 510(k)

FDA Class 2 ·Dental

HIOSSEN PROSTHETIC SYSTEM

FDA 510(k)

FDA Class 2 ·Dental

CALTAG CD3 FITC, R-PE, TRI-COLOR MONOCLONAL ANTIBODY

FDA 510(k)

FDA Class 2 ·Hematology

INFINITT ULite

FDA 510(k)

FDA Class 2 ·Radiology

MULTI ANGLED ABUTMENT

FDA 510(k)

FDA Class 2 ·Dental

PRE-MILLED Abutment

FDA 510(k)

FDA Class 2 ·Dental

IBS Implant System II

FDA 510(k)

FDA Class 2 ·Dental

SILICATH ALL SILICONE FOLEY CATHETER

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

GATED MIBI 3-D EJECTION FRACTION PROCESSING

FDA 510(k)

FDA Class 2 ·Radiology

DRI HEMOGLOBIN A1C ASSAY AND CALIBRATORS

FDA 510(k)

FDA Class 2 ·Hematology

Carex Hybrid Personal Lubricant

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

Picocare

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

CARESENS N LINK BLOOD GLUCOSE MONITORING SYSTEM; CARESENS N LINK MULTI BLOOD BLUCOSE MONITORING SYSTEM

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

Magicore System

FDA 510(k)

FDA Class 2 ·Dental

MULITPLE MALE LATX CONDOM

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

CARESENS N VOICE MULTI BLOOD GLUCOSE MONITORING SYSTEM, CARESENS N VOICE MULTI BLOOD GLUCOSE METER

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

DLP SILICONE CORONARY ARTERY OSTIAL CANNULAE

FDA 510(k)

FDA Class 2 ·Cardiovascular