Infrared Forehead Thermometer, Model LFR30B, LFR50, LFR60

FDA 510(k)

FDA Class 2 ·General Hospital

ACCUSTEP DOA SINGLE AND MULTI-STRIP SCREEN PANELS

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

Generator, Pulse, Pacemaker, External Programmable (For Electrophysiological Studies Only)

FDA Pre-Market Approval

FDA Class 2 ·MODEL 4553 DUAL CHAM. DDD TEMP.CARDIAC PACEMAKER

Generator, Pulse, Pacemaker, External Programmable (For Electrophysiological Studies Only)

FDA Pre-Market Approval

FDA Class 2 ·MICRO-PACE DUAL-CHAMBER, DDD, TEMPORARY CARDIAC PACEMAKER

Generator, Pulse, Pacemaker, External Programmable (For Electrophysiological Studies Only)

FDA Pre-Market Approval

FDA Class 2 ·MODEL 4553 DUAL CHAM. DDD TEMP.CARDIAC PACEMAKER

Generator, Pulse, Pacemaker, External Programmable (For Electrophysiological Studies Only)

FDA Pre-Market Approval

FDA Class 2 ·MICRO-PACE MODEL 4553 DUAL CHAMBER DDD TEMPORARY CARDIAC PACEMAKER

Generator, Pulse, Pacemaker, External Programmable (For Electrophysiological Studies Only)

FDA Pre-Market Approval

FDA Class 2 ·MODEL 4553 DUAL CHAM. DDD TEMP.CARDIAC PACEMAKER

Generator, Pulse, Pacemaker, External Programmable (For Electrophysiological Studies Only)

FDA Pre-Market Approval

FDA Class 2 ·MODEL 4553 DUAL CHAM. DDD TEMP.CARDIAC PACEMAKER

MODEL CBC-1 COA COMP ANTI-STICKING BIPOLAR COAG.

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

MODEL CBC-1 COA-COMP ANTI-STICKING BIOPOLAR COAG.

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

BIONEXIA OPTICUP MULTI-STRIP DOA DIPSTICK TEST INTEGRATED CUP

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

HEMACON-DOA(TM) DRUGS OF ABUSE WHOLE BLOOD CONTROL

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

2-in-1 Abdominal Muscle Training & Back Pain Relief System

FDA 510(k)

FDA Class 2 ·Neurology

Models 2200DR and 1600DR Digital Stationary Radiographic Systems

FDA 510(k)

FDA Class 2 ·Radiology

ACCUSIGN DOA 10, ACCUSIGN DOA 10 PANEL, ACUSIGN MET/OPI/COC/THC/PCP/BZO/BAR/MTD/TCA/AMP, BIOSIGN DOA10, BIOSIGN MET/OPI/

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

ACCUSIGN DOA 5 (THC/OPI/COC/MET OR AMP/PCP)

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

Atlas Multi-Drugs Screening Test Cup, Atlas Multi-Drugs Screening Test Panel

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

Eon Aligner

FDA 510(k)

FDA Class 2 ·Dental

ATLAS HOME PREGNANCY TEST (MIDSTREAM FORMAT) MODEL 70172001

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

Flexible Sensor-Ureterorenoscopes BOA Vision EF, Flexible Sensor-Ureterorenoscopes COBRA Vision EF

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology