Alzair Allergy Blocker

FDA 510(k)

FDA Class 2 ·General Hospital

AllerBlock Junior

FDA 510(k)

FDA Class 2 ·General Hospital

IMMUNOCYT

FDA 510(k)

FDA Class 2 ·Hematology

SWAN-GANZ THERM CATH SM HEART AMC THROM 93A102H5F

FDA 510(k)

FDA Class 2 ·Cardiovascular

Adaptive Motion Correction (AMC), CSMC-001A and 4D Airways

FDA 510(k)

FDA Class 2 ·Radiology

ORTHOMET LHMC FEMORAL STEM

FDA 510(k)

FDA Class 2 ·Ophthalmic

SWAN-GANZ(R) HI-SHORE(R) THERMO CATH W/AMC(TM)

FDA 510(k)

FDA Class 2 ·Cardiovascular

NG-Test CARBA 5

FDA 510(k)

FDA Class 2 ·Microbiology

RAPIDEC CARBA NP

FDA 510(k)

FDA Class 2 ·Microbiology

NG-Test® CTX-M MULTI

FDA 510(k)

FDA Class 2 ·Microbiology

VANTEX CENTRAL VENOUS CATHETER WITH OLIGON MATERIAL WITH OR WITHOUT AMC THROMBOSHIELD COATING

FDA 510(k)

FDA Class 2 ·General Hospital

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

RETINA TOMOGRAPH AND FLOWMETER

FDA 510(k)

FDA Class 2 ·Ophthalmic

RETINA FLOWMETER

FDA 510(k)

FDA Class 2 ·Ophthalmic