10 ML BAK'SNAP DUOPROSS RETRACTABLE SAFETY SYRINGE

FDA 510(k)

FDA Class 2 ·General Hospital

DUOPRO SAFETY SYRINGE (DUOPROSS)

FDA 510(k)

FDA Class 2 ·General Hospital

DUOPRO SAFETY SYRINGE (DUOPROSS)

FDA 510(k)

FDA Class 2 ·General Hospital

MAK-6 MONOCLONAL ANTI-CYTOKERATIN COCKTAIL

FDA 510(k)

FDA Class 2 ·Immunology

MULTIPLE ARTIFICIAL KIDNEY SYSTEMS (MAKS) #IDM

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

ONTRAK TESTSTIK FOR MORPHINE 2000 (M2K)

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

Analyzer, Medical Image

FDA Pre-Market Approval

FDA Class 2 ·IMAGECHECKER M1000 SYSTEM

MAKS CENTRAL DELIVERY SYS-11-200 ETC

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

ONTRAK TESTCUP M2K, MODEL CAT. 11 1849 8

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·SPRINTER MX2 BALLOON DILATATION CATHETER

Paper Sterilization Pouch and Roll(Sterilization Pouch Flat, Sterilization Pouch Gusseted, Sterilization Roll Flat and Sterilization Roll Gusseted)

FDA 510(k)

FDA Class 2 ·General Hospital

MAKS CENTRAL DELIVERY SYSTEMS MODELS 11-425/11-445

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

MERIT MAK (MINI ACCESS KIT) WITH PALLADIUM TIP GUIDE WIRE

FDA 510(k)

FDA Class 2 ·Cardiovascular

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·NC STORMER MX2/OTW BALLOON DILATATION CATHETER

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·MEDTRONIC VASCULAR NC STORMER MX2 BALLON DILATATION CATHETER

System, Test, Carcinoembryonic Antigen

FDA Pre-Market Approval

FDA Class 2 ·TANDEM(R) E CEA IMMUNORADIOMETRIC ASSAY

NaviENT

FDA 510(k)

FDA Class 2 ·Neurology

POLYURETHANE SOLUTION 29% W/W

FDA 510(k)

FDA Class 2 ·Dental

Navident

FDA 510(k)

FDA Class 2 ·Dental

Navident

FDA 510(k)

FDA Class 2 ·Dental