HOT SACK

FDA 510(k)

FDA Class 2 ·General Hospital

A-1 IN-HOME PREGNANCY TEST

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

5.2F DUAL LUMEN EXTENDED LENGTH CATHETER (DELC)

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

MINI-BEEP

FDA 510(k)

FDA Class 2 ·Physical Medicine

SYSTEM 100; S-100 ULTRAFILTRATION CONSOLE; BDT 500 ULTRAFILTRATION SET

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

AQUADEX SYSTEM

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

ACU-SLIDE TEST

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

SYSTEM 100 ULTRAFILTRATION CATHETER

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Patient Monitor, models LM-8, LM-10, LM-12 and LM-15

FDA 510(k)

FDA Class 2 ·Cardiovascular

LE-12CH

FDA 510(k)

FDA Class 2 ·Cardiovascular

Patient Monitor, models LMPLUS-12, LMPLUS-15 and LMPLUS-17

FDA 510(k)

FDA Class 2 ·Cardiovascular

RAPID METHADONE TEST STRIP, MODEL 7019 & RAPID METHADONE TEST CARD, MODEL 7020

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

RAPID OPIATES TEST STRIP II, RAPID OPIATES TEST CARD II AND DOA MULTIPLE DRUG TEST CARDS (UP TO SIX TESTS)

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

RAPID BARBITURATE TEST STRIP AND TEST CARD, MODELS 7015 AND 7016

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

RAPID DRUGS OF ABUSE SINGLE AND MULTIPLE TEST PANELS

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

R-C1 TENS and EMS Stimulator; R-E1- EMS Stimulator; R-T1 TENS Stimulator

FDA 510(k)

FDA Class 2 ·Physical Medicine

Electrical Stimulator - Model R-C1 TENS and EMS stimulator, Model R-E1 EMS stimulator, Model R-T1 TENS Stimulator

FDA 510(k)

FDA Class 2 ·Neurology

PlaniMax Orthodontic Software

FDA 510(k)

FDA Class 2 ·Dental

SURGICLA INSTRUMENT KIT

FDA 510(k)

FDA Class 2 ·General Hospital

Ortho Solutions Plating System

FDA 510(k)

FDA Class 2 ·Orthopedic