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

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

TEMPORARY BIPOLAR MYOCARDIAL PACING WIRE

FDA 510(k)

FDA Class 2 ·Cardiovascular

Ensmile

FDA 510(k)

FDA Class 2 ·Dental

Byonyks X-1 APD Cycler; Byonyks Automated PD Set DS-1

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

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

Z-RAY INTRA-ORAL DIGITAL RADIOGRAPHY SYSTEM

FDA 510(k)

FDA Class 2 ·Dental

NOVEL PRINT CYAN ALGINATES

FDA 510(k)

FDA Class 2 ·Dental

ID MILLENNIUM, ID MOMENTS SILICONE

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

FEMMYCYCLE

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

QUICKPROFILE SINGLE DRUG OF ABUSE DEVICE AND QUICK PROFILE MULTI-DRUGS OF ABUSE SCREEN DEVICE

FDA 510(k)

FDA Class 2 ·Clinical Toxicology