TERUMO SENSIBEAD EIG HCG KIT

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

EPIDURAL MINI KIT, ELDOR COMBINED SPINAL/EPIDURAL KIT

FDA 510(k)

FDA Class 2 ·Anesthesiology

Burn Resuscitation Decision Support System - Clinical (BRDSS-C)

FDA 510(k)

FDA Class 2 ·Anesthesiology

MAPS 10000

FDA 510(k)

FDA Class 2 ·Radiology

FROG (Filter Removal of Glass)

FDA 510(k)

FDA Class 2 ·General Hospital

BD Phoenix™ Automated Microbiology System

FDA 510(k)

FDA Class 2 ·Microbiology

MTF ALLOGRAFT ANCHOR

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

WHITSOFT

FDA 510(k)

FDA Class 1 ·Clinical Chemistry

SPECTACLE FRAME

FDA 510(k)

FDA Class 1 ·Ophthalmic

SPRAYGENIX CRYO ABLATION SYSTEM

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

APS SERIES DIALYZERS (WET MODELS), APS SERIES DIALYSIS (DRY MODELS)

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

STEREOTACTIC BODY FRAME, MODEL COD. 70-1A

FDA 510(k)

FDA Class 2 ·Radiology

IDI-VANR ASSAY

FDA 510(k)

FDA Class 2 ·Microbiology

SINOVENT MAXILLARY SINUS DRAINAGE SYSTEM

FDA 510(k)

FDA Class 1 ·General, Plastic Surgery

DMI LAPAROSCOPIC IRRIGATION PUMP

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

FUTREX-5000

FDA 510(k)

FDA Class 2 ·Cardiovascular

HEAT STACK

FDA 510(k)

FDA Class 2 ·General Hospital

WIESLAB CAP MPO-ANCA

FDA 510(k)

FDA Class 2 ·Immunology

AMBIDERM LATEX EXAMINATION GLOVES (VIOLET, BLUE , GREEN, AND PINK) CONTAINING 50 MCGM OR LESS OF TOTAL WATER EXTRACTABLE

FDA 510(k)

FDA Class 1 ·General Hospital

INDIRECT FLUORESCENT ASSAY FOR HERPES SIMPLEX 1

FDA 510(k)

FDA Class 2 ·Microbiology