GE LOGIQ 7 ULTRASOUND BT04

FDA 510(k)

FDA Class 2 ·Radiology

GE LUNAR DPX & PRODIGY SERIES DEXA BONE DENSITOMETERS WITH MOBILE KIT

FDA 510(k)

FDA Class 2 ·Radiology

GE LUNAR VISCERAL FAT SOFTWARE

FDA 510(k)

FDA Class 2 ·Radiology

GE LUNAR FEMUR STRENGTH SOFTWARE

FDA 510(k)

FDA Class 2 ·Radiology

GE LOGIQ BT08 DIAGNOSTIC ULTRASOUND SYSTEM

FDA 510(k)

FDA Class 2 ·Radiology

Handheld VitalSigns Monitoring System

FDA 510(k)

FDA Class 2 ·Cardiovascular

Project E Beauty LED Light Therapy Mask (Model: PE730)

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Infrared Thermometer (Model: LX-26E, LX-260TE, PRO LX-261E, LX-360, LX-361T, BW-CX10)

FDA 510(k)

FDA Class 2 ·General Hospital

GALEMED PEAK FLOW METER, MODELS 3751/3752

FDA 510(k)

FDA Class 2 ·Anesthesiology

ORTHOSORB LS

FDA 510(k)

FDA Class 2 ·Orthopedic

ORTHOSORB(R) ABSORBABLE PIN

FDA 510(k)

FDA Class 2 ·Orthopedic

ORTHOSORB RESORBABLE PINS

FDA 510(k)

FDA Class 2 ·Orthopedic

CYFRA 21-1 EIA MODEL 211-10

FDA 510(k)

FDA Class 2 ·Immunology

Elecsys CYFRA 21-1, Elecsys CYFRA 21-1 CalSet, PreciControl Tumor Marker

FDA 510(k)

FDA Class 2 ·Immunology

Hepatitis A Test (Antibody And Igm Antibody)

FDA Pre-Market Approval

FDA Class 2 ·ABBOTT HAVAB-M 7180/ HAVAB-M EIA 9843/IMX HAVAB-M 2263

Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers

FDA Pre-Market Approval

FDA Class 2 ·Elecsys free PSA Test System

Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers

FDA Pre-Market Approval

FDA Class 2 ·Elecsys free PSA Test System

Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers

FDA Pre-Market Approval

FDA Class 2 ·Elecsys free PSA

Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers

FDA Pre-Market Approval

FDA Class 2 ·Dimension TPSA Flex reagent cartridge (RF451)

Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers

FDA Pre-Market Approval

FDA Class 2 ·IMMULITE/IMMULITE 1000 PSA & 1000 THIRD GENERATION PSA