MICROSPAN INSEMINATION SYSTEM

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

IMAGYN MICROLAP AND MICRO LAP-GOLD LAPAROSCOPES

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

MICROSPAN HYSTEROSCOPE

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

IMAGYN ENDOSCOPE

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

MICROSPAN HYSTEROSCOPE SHEATH

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

REDTECH GIPC 2000

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

IMAGYN INTRAUTERINE INSEMINATION DEVICE

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

IMAGYN ENDOSCOPE SHEATH

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

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

MicroScan Dried Gram-Negative MIC/Combo Panels with Ceftazidime (Caz) (0.5-64 µg/mL )

FDA 510(k)

FDA Class 2 ·Microbiology

PATHWAY ACCESS SHEATH CATHETER

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

PATHWAY ACCESS SHEATH CATHETER

FDA 510(k)

FDA Class 2 ·Cardiovascular

PATHWAY URETERAL ACCESS SHEATH, PATHWAY EXPANDABLE URETERAL ACCESS SHEATH

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

PATHWAY BALLOON EXPANDABLE URETERAL ACCESS SHEATH, MODEL BEUS

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

KOBRA GPS FIXATION SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

BALLOON EXPANDABLE TRANSSEPTAL INDRODUCER, MODELS BETI-1840 AND BETI-1870

FDA 510(k)

FDA Class 2 ·Cardiovascular

CLEARFLASH AC2100 COSMETIC SYSTEM

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

DREAM COLOR I (POLYMACON) SOFT (HYDROPHILIC) CONTACT LENS, DREAM COLOR II (POLYMACON) SOFT (HYDROPHILIC) CONTACT LENS, D

FDA 510(k)

FDA Class 2 ·Ophthalmic

SD GLUCONAVII MENTOR NFC MULTI BLOOD GLUCOSE MONITORING SYSTEM, AND SD GLUCONAVII MENTOR NFC BLOOD GLUCOSE MONITORING SYSTEM

FDA 510(k)

FDA Class 2 ·Clinical Chemistry