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

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

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

FDA 510(k)

FDA Class 2 ·Microbiology

SYNTHES TI-6AI-7NB UNREAMED FEMORAL NAIL

FDA 510(k)

FDA Class 2 ·Orthopedic

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

TOTIM Patient Cushion Immobilization System

FDA 510(k)

FDA Class 2 ·Radiology

Apogee 6500,Apogee 6300,Apogee 6200 Digital Color Doppler Ultrasound Imaging System

FDA 510(k)

FDA Class 2 ·Radiology

DC-N3/DC-NS3 DIAGNOSTIC ULTRASOUND SYSTEM

FDA 510(k)

FDA Class 2 ·Radiology

3N Contact Lenses Adjunct Cleaner

FDA 510(k)

FDA Class 2 ·Ophthalmic

SR-8230, SR-8230S Portable X-ray Unit

FDA 510(k)

FDA Class 2 ·Radiology

ePM Series Patient monitors

FDA 510(k)

FDA Class 2 ·Cardiovascular

Passport Series Patient Monitors(Passport 12m, Passport 17m)

FDA 510(k)

FDA Class 2 ·Cardiovascular

Apogee 5500/Apogee 5300/ Apogee 5800 Digital Color Doppler Ultrasound Imaging System

FDA 510(k)

FDA Class 2 ·Radiology

ePM Series Patient monitors

FDA 510(k)

FDA Class 2 ·Cardiovascular

V Series Monitoring System (including V12 and V21 Monitors)

FDA 510(k)

FDA Class 2 ·Cardiovascular

TK Insulin Syringe with/without Saftey Retractable Device

FDA 510(k)

FDA Class 2 ·General Hospital

Disposable Surgical Mask

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery