TITAN INSUFFLATION NEEDLE

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

ENDOLAP INSUFFLATOR TUBING SET

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

SEALOUETTE FIBRIN SEALANT APPLICATOR

FDA 510(k)

FDA Class 2 ·General Hospital

INSIGHT IMAGE GUIDED SURGICAL SYSTEM

FDA 510(k)

FDA Class 2 ·Neurology

ETEST Aztreonam/Avibactam (AZA) (0.016/4-256/4 µg/mL)

FDA 510(k)

FDA Class 2 ·Microbiology

MODEL EB-22 NOISE STIK

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

Accessories, Soft Lens Products

FDA Pre-Market Approval

FDA Class 2 ·ARMSTRONG STERILE SALINE SOLUTION

System, Test, Carcinoembryonic Antigen

FDA Pre-Market Approval

FDA Class 2 ·CEA-ROCHE TEST KIT

System, Test, Carcinoembryonic Antigen

FDA Pre-Market Approval

FDA Class 2 ·CEA-ROCHE TEST KIT

System, Test, Carcinoembryonic Antigen

FDA Pre-Market Approval

FDA Class 2 ·CEA-ROCHE TEST KIT

System, Test, Carcinoembryonic Antigen

FDA Pre-Market Approval

FDA Class 2 ·CEA-ROCHE TEST KIT

VAS-CATH URETERAL STENT CATHETER

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

MODIFIED VAS-CATH CATHETER REPAIR KIT

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

VAS-CATH URETERAL STENTS CATHETER, MODIFICATION

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

OPTI-PLAST 5F PTA CATHETERS, MODIFICATION

FDA 510(k)

FDA Class 2 ·Cardiovascular

VENOWAVE MODELS VW5-6, VW5-10, VW5-20 AND VW5-30

FDA 510(k)

FDA Class 2 ·Cardiovascular

VAS-CATH CATHETER REPAIR KIT

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

HeartCheck Cardi Beat ECG Monitor with GEMS Mobile

FDA 510(k)

FDA Class 2 ·Cardiovascular

VAS-CATH INC. OPTI-PLAST ANGIOPLASTY CATHETER

FDA 510(k)

FDA Class 2 ·Cardiovascular

VAS-CATH OPTI-PLAST 5F PERIPHERAL ANGIOPLASTY CATH

FDA 510(k)

FDA Class 2 ·Cardiovascular