ePlex Instrument

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

SECHRIST AIR/OXYGEN MIXER, MODEL 3500 CP-G

FDA 510(k)

FDA Class 2 ·Cardiovascular

ePlex Blood Culture Identification Panel - Gram Positive (BCID-GP) Panel

FDA 510(k)

FDA Class 2 ·Microbiology

CLP GLYCOSYLATED HEMOGLOBIN CONTROL-NR

FDA 510(k)

FDA Class 2 ·Hematology

ANTIMICROBIAL SUSCEPTIBILITY TEST PANEL

FDA 510(k)

FDA Class 2 ·Microbiology

MICROSPAN HYSTEROSCOPE SHEATH

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

ANTIMICROBIAL SUSCEPTIBILITY TEST PANEL/MODIFIED

FDA 510(k)

FDA Class 2 ·Microbiology

SoloSmart Injection Pen Adapter (SoloSmart®)

FDA 510(k)

FDA Class 2 ·General Hospital

SICKLE HEMOGLOBIN (HBA/S) CONTROL SET

FDA 510(k)

FDA Class 2 ·Hematology

REDTECH GIPC 2000

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

IMAGYN INTRAUTERINE INSEMINATION DEVICE

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

CRYSTAL VISION AND ACCESSORIES

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

SPECULUM SMOKE EVACUATOR TUBING

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

IMAGYN ENDOSCOPE SHEATH

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

MALIBU SPINAL SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

CHRYS(TM) MODEL MED-MAX

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

SEASPINE SPACER SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

IMAGYN EXPANDABLE LAPAROSCOPIC INTRODUCER

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

IMAGYN MEDICAL INFLATION DEVICE WITH NON-INVASIVE PRESSURE TUBING

FDA 510(k)

FDA Class 2 ·Cardiovascular

SURGEN VALVE

FDA 510(k)

FDA Class 2 ·General Hospital