AIRPREP SYSTEM - MODEL 9001

FDA 510(k)

FDA Class 2 ·Dental

ADVANCED ENDODONTIC SYSTEM- DESIGNER SERIES

FDA 510(k)

FDA Class 2 ·Dental

ACTHK-PR RIA KIT

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

Geon (S2) Nasal Aspirator

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Lenses, Soft Contact, Daily Wear

FDA Pre-Market Approval

FDA Class 2 ·CSI (CROFILCON A) EXTENDED WEAR SOFT (HYDROPHILIC) CONTACT LENS

ASI Automated RPR (rapid plasma reagin) Test for Syphilis, for use on the ASI Evolution Automated Syphilis Analyzer

FDA 510(k)

FDA Class 2 ·Microbiology

CSL X-RAY IMAGESCOPE

FDA 510(k)

FDA Class 2 ·Radiology

COMPACT AUTO-SAFETY INJECTOR (CASI)

FDA 510(k)

FDA Class 2 ·General Hospital

AUTO-SAFETY INJECTOR-2 (ASI-2)

FDA 510(k)

FDA Class 2 ·General Hospital

ASI LIGASURE(TM) SUTURE LIGATION INSTRUMENT

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

DNA/RNA Shield SafeCollect Saliva Collection kit

FDA 510(k)

FDA Class 2 ·Microbiology

DNA/RNA Shield Collection Tube

FDA 510(k)

FDA Class 2 ·Microbiology

BIOFIRE Blood Culture Identification 2 (BCID2) Panel (RFIT-ASY-0147 (30 pack) RFIT-ASY-0148 (6 pack))

FDA 510(k)

FDA Class 2 ·Microbiology

MINOLTA PULSOX-3SI, PULSOX-3IA, PULSOX-3LI

FDA 510(k)

FDA Class 2 ·Cardiovascular

ASI CYSTOSCOPE SHEATH, GRASPING FORCEPS & FOR.BODY

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

ASI TCU PROSTATIC URETHROPLASTY CATHETER & ACCESS.

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

1-M GRADUATED COMPRESSION ANTI-EMBOLISM STOCKING, MODEL SS-811, SS-508, SS-613

FDA 510(k)

FDA Class 2 ·General Hospital

ASI DEIONIZER & CARBON EXCHANGE SERVICE FOR HEMODIALYSIS

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

JBAIDS PLAQUE DETECTION KIT, MODEL JRPD-ASY-0123

FDA 510(k)

FDA Class 2 ·Microbiology

JBAIDS TULAREMIA DETECTION KIT, MODEL JRPD-ASY-0124

FDA 510(k)

FDA Class 2 ·Microbiology