CALCIJECT

FDA 510(k)

FDA Class 2 ·Dental

MODIFIED HAND INSTRUMENT DEVICES

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

TURBO AIR COMPRESSOR 8000

FDA 510(k)

FDA Class 2 ·Anesthesiology

GDC 1742 (A CASTING ALLOY FOR DENTAL RESTORATIONS)

FDA 510(k)

FDA Class 2 ·Dental

OSCILLOMATE EMS NIBP MONITOR MODEL 9001

FDA 510(k)

FDA Class 2 ·Cardiovascular

RMU-2000 Automated Chest Compression System

FDA 510(k)

FDA Class 2 ·Cardiovascular

Swoop Portable MR Imaging System

FDA 510(k)

FDA Class 2 ·Radiology

ENDOMETRIAL PIPELLE

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

MARTANIQUE 6-TUBE HOME SOLARIUM

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

IMUBIND PLASMA PAI-1 ELISA,MODEL 822

FDA 510(k)

FDA Class 2 ·Hematology

OPC 3G ALL-CERAMIC SYSTEM, CORE AND OVERLAY PORCELAINS

FDA 510(k)

FDA Class 2 ·Dental

FLEXON TEMPORARY CARDIAC PACER LEAD

FDA 510(k)

FDA Class 2 ·Cardiovascular

CLEANFLOW SYSTEM

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

HI VISION ASCENDUS, HV ASCENDUS, ASCENDUS

FDA 510(k)

FDA Class 2 ·Radiology

MODEL 750E SERIES MONITOR

FDA 510(k)

FDA Class 2 ·Cardiovascular

Synapse PACS

FDA 510(k)

FDA Class 2 ·Radiology

ACUTRON MULTIWAVE FOR USE IN TMJ SYNDROME PAIN CON

FDA 510(k)

FDA Class 2 ·Physical Medicine

NEEDLETUBE SYRINGE CARTRTIDGE

FDA 510(k)

FDA Class 2 ·Dental

Signia Circular Adapters (for use with Signia Staplers), Tri-Staple 2.0 Circular Reloads (for use with Signia Circular Adapters)

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

TEMPIT-E

FDA 510(k)

FDA Class 2 ·Dental