Lenses, Soft Contact, Daily Wear

FDA Pre-Market Approval

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

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

FOUNDATION HYBRID COMPOSITE

FDA 510(k)

FDA Class 2 ·Dental

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

FDA 510(k)

FDA Class 2 ·Microbiology

COMPEX SPORT

FDA 510(k)

FDA Class 2 ·Physical Medicine

STAIRFRIEND CURVED STAIRWAY CHAIRLIFT

FDA 510(k)

FDA Class 2 ·Physical Medicine

SANKEN MAT

FDA 510(k)

FDA Class 2 ·General Hospital

V-1504 VERTICAL PLATFORM LIFT

FDA 510(k)

FDA Class 2 ·Physical Medicine

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

Multi-Lancet Device 2, ReliOn Premier Lancing Device

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

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

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

FDA 510(k)

FDA Class 2 ·General Hospital

Disposable Surgical Face Mask

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

BETACHEK GLUCOSE TEST

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

DISPOSABLE ACCESSORIES FOR I/A SYS. & VITEOUS CUT.

FDA 510(k)

FDA Class 2 ·Ophthalmic