Modius Stress

FDA 510(k)

FDA Class 2 ·Neurology

Flexi-Seal Signal Fecal Management System

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

AXSYM ANTI-CCP REAGENT, STANDARD CALIBRATOR AND CONTROL KITS, MODELS 3L91-20, 3L91-01 AND 3L91-10

FDA 510(k)

FDA Class 2 ·Immunology

Unicare (K-UNICARE-USA)

FDA 510(k)

FDA Class 2 ·Neurology

GAMMA-BCT INTACT PTH

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

LOMEFLOXACIN ANTIMICROBIAL SUSCEPTIBILITY TEST DISC

FDA 510(k)

FDA Class 2 ·Microbiology

KEELER SLIT LAMP H-SERIES

FDA 510(k)

FDA Class 2 ·Ophthalmic

ESCHMANN ELECTROSURGICAL UNIT, MODEL TD411

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

PICO 7 Single Use Negative Pressure Wound Therapy System, PICO 14 Single Use Negative Pressure Wound Therapy System, PICO Fluid Management Packs

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

QACA IGG/IGM ELISA KIT HRP

FDA 510(k)

FDA Class 2 ·Immunology

BIOSLEEP

FDA 510(k)

FDA Class 2 ·Neurology

BABY DOPPLEX 4000 (BD4000)

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

ProVu Single Use Video Stylet with Reinforced ET Tube (Size 6.5) (038-995-065U); ProVu Single Use Video Stylet with Reinforced ET Tube (Size 7.0) (038-995-070U); ProVu Single Use Video Stylet with Reinforced ET Tube (Size 7.5) (038-995-075U); ProVu Single Use Video Stylet with Reinforced ET Tube (Size 8.0) (038-995-080U)

FDA 510(k)

FDA Class 2 ·Anesthesiology

CoreLite X-Ray Specimen Cabinet

FDA 510(k)

FDA Class 2 ·Radiology

SC+ Hemodialysis Device (SC-14269); Dialysate Cartridge (SC-14656); Blood Tube Set (SC-14651)

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Quick-Start Orthopaedic Fixation Screw and Reverse Thread Screw

FDA 510(k)

FDA Class 2 ·Orthopedic

DOMINATOR

FDA 510(k)

FDA Class 2 ·Orthopedic

INFANT FLOW SYSTEM, MODEL M672P

FDA 510(k)

FDA Class 2 ·Anesthesiology

MICROMANIPULATOR

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

SPARFLOXACIN ANTIMICROBIAL SUSCEPTIBILITY TEST DISC

FDA 510(k)

FDA Class 2 ·Microbiology