NG-Test® CTX-M MULTI

FDA 510(k)

FDA Class 2 ·Microbiology

CentroVena Central Venous Catheter (CVC) with the CentroVena One Insertion System

FDA 510(k)

FDA Class 2 ·General Hospital

NOVA CO-OXIMETER ANALYZER

FDA 510(k)

FDA Class 2 ·Hematology

NOVA 16 ANALYZER (MODIFICATION POINT OF CARE USAGE)

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

STAT PROFILE ULTRA 11 ANALYZER (MODIFICATION)

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

STAT PROFILE PHOX ANALYZER

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

STAT PROFILE PHOX CO-OXIMETER ANALYZER, NOVA CO-OXIMETER CONTROLS, LEVELS 1 AND 2, NOVA CO-OXIMETER THB CALIBRATOR

FDA 510(k)

FDA Class 2 ·Hematology

Integrity V500 (Integrity, Integrity with VEMP)

FDA 510(k)

FDA Class 2 ·Neurology

VIVOSONIC NEUROSCREEN

FDA 510(k)

FDA Class 2 ·Neurology

SAM CRRT Unit, SAM Cassette CRRT

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Endotoxin Activity Assay (EAA)

FDA 510(k)

FDA Class 2 ·Microbiology

SPECTRAL WEST NILE VIRUS IGM STATUS TEST

FDA 510(k)

FDA Class 2 ·Microbiology

ProCell Surgical Sponge-Blood Recovery Unit

FDA 510(k)

FDA Class 2 ·Anesthesiology

BI-FLEX URETERAL ACCESS SHEATH

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

JFil Ureteral Stents, JFil Ureteral Stents ECO KIT

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

ENDOFLOW II - Irrigation, Warming and Suction System

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

RocaJJ Soft Stents

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

ROCAMED ROCAUS PLATINUM

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

RocaTub Ureteral Catheter

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Bi-Flex Evo

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology