SYVA EMIT II METHADONE ASSAY

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

AMPHETAMINES ENZYME IMMUNOASSAY, CATALOG #0040 (500 TESTS KIT), CATALOG #0041 (5000 TESTS KIT)

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

AVIE TOTAL HB TEST SYSTEM

FDA 510(k)

FDA Class 2 ·Hematology

CANNABINOID ENZYME IMMUNOASSAY, CATALOG 0070, 0071

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

VANSONNENBERG GASTROSTOMY CATHETER

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

LASERSCOPE VELA ERBIUM:YAG LASER SYSTEM AND ACCESSORIES

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

TRITEST REAGENT CD3 FITC/CD8 PE/CD45 PERCP;WITH TRUCOUNT ABSOLUTE COUNT TUBES

FDA 510(k)

FDA Class 2 ·Hematology

iFuse Implant System- iFuse Navigation

FDA 510(k)

FDA Class 2 ·Neurology

STERISAFE HP TABLE-TOP STEAM STERILIZER

FDA 510(k)

FDA Class 2 ·General Hospital

EMIT 2000 PHENOBARBITAL ASSAY, MODEL OSR4D229

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

800 SERIES SURGICAL LASER SYSTEM ORION SERIES SURGICAL LASER SYSTEM ANGLED DELIVERY DEVICES

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

NESSY SURESTICK(TM)/STANDARD SURESTICK(TM)

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

MICRUS ONE 2 ONE GUIDEWIRE AND SOFT GUIDEWIRE

FDA 510(k)

FDA Class 2 ·Cardiovascular

V-CATH PERCUTANEOUS INTRODUCER KIT

FDA 510(k)

FDA Class 2 ·General Hospital

MICRUS MICROCOIL SYSTEM, DELTAPAQ 10 STRETCH RESISTANT

FDA 510(k)

FDA Class 2 ·Neurology

MODIFICATION TO THE EMIT II PLUS PROPOXYPHENE ASSAY, MODEL OSR9G229

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

Spirair Nasal Septal Strap

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

HipCheck

FDA 510(k)

FDA Class 2 ·Radiology

1688 4K Camera Control Unit with Advanced Imaging Modality (1688010000)

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

CIRCAMED HOLTER VERSION 4

FDA 510(k)

FDA Class 2 ·Cardiovascular