B-Secur HeartKey Software Library

FDA 510(k)

FDA Class 2 ·Cardiovascular

CLEARPLAN EASY II HOME PREGNANCY TEST

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

AZITHROMYCIN ANTIMICROBIAL SUSCEPTIBILITY TEST DISC

FDA 510(k)

FDA Class 2 ·Microbiology

LIQUIBAND FLOW CONTROL

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

TENSCARE ITOUCH SURE MODEL ITS

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

I-LIPO SYSTEM

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

IMMULITE® 2000 Cortisol

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

COMPACT AUTO-SAFETY INJECTOR (CASI)

FDA 510(k)

FDA Class 2 ·General Hospital

PORTEX PERCUTANEOUS DILATATIONAL TRACHEOSTOMY KITS

FDA 510(k)

FDA Class 2 ·Anesthesiology

VICKERS MEDICAL MODEL 272 TEMPERATURE MONITOR

FDA 510(k)

FDA Class 2 ·General Hospital

SURESAMPLE-WALLACE ENDOMETRIAL SAMPLER, ENDO 26

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

QAB2A IGM ELISA KIT

FDA 510(k)

FDA Class 2 ·Immunology

RANDOX DIGOXIN ASSAY

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

Insufflator, Endoscopic Vessel Harvesting

FDA classification

FDA Class 2 ·Insufflator, Endoscopic Vessel Harvesting

Hydrophilic Re-Coating Solution

FDA classification

FDA Class 2 ·Hydrophilic Re-Coating Solution

Gas Chromatography, Primidone

FDA classification

FDA Class 2 ·Gas Chromatography, Primidone

Gas Chromatography, Opiates

FDA classification

FDA Class 2 ·Gas Chromatography, Opiates

Gas Chromatography, Propoxyphene

FDA classification

FDA Class 2 ·Gas Chromatography, Propoxyphene

Gas Chromatography, Phenobarbital

FDA classification

FDA Class 2 ·Gas Chromatography, Phenobarbital

Gas Chromatography, Benzodiazepine

FDA classification

FDA Class 2 ·Gas Chromatography, Benzodiazepine