Flexible Video-Choledochoscope (CHV-110J-U); Flexible Video-Choledochoscope (CHV-US120J-U)

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Surgical Face Mask (Tie on/ Ear loops)

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

AIE REGION OF INTEREST IMAGE ENHANCEMENT

FDA 510(k)

FDA Class 2 ·Radiology

H. INFLUENZA B ANTISERA FOR CIE

FDA 510(k)

FDA Class 2 ·Microbiology

CAD-2000 CARDIAC ASSIST DEVICE

FDA 510(k)

FDA Class 2 ·Cardiovascular

Portable Liver Elastography Ultrasound Diagnostic System (Liverscan Mobile)

FDA 510(k)

FDA Class 2 ·Radiology

EN TYPING CIE KIT FOR DIAGNOSTIC USE

FDA 510(k)

FDA Class 2 ·Immunology

ENA SCREENING CIE KIT FOR DIAGNOSTIC USE

FDA 510(k)

FDA Class 2 ·Immunology

Sharps Needle Destruction Device

FDA Pre-Market Approval

FDA Class 2 ·NEEDLE ZAP (R)

Sharps Needle Destruction Device

FDA Pre-Market Approval

FDA Class 2 ·NEEDLE ZAP

Portable Liver Elastography Ultrasound Diagnostic System (Liverscan C)

FDA 510(k)

FDA Class 2 ·Radiology

AZUL PERSONAL LUBRICANT

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

Trojan Supra Lubricated Polyurethane Male Condom

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

Trojan Chain Reaction Natural Rubber Latex Condom with Sensate Lubricant

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

EUROTROL HEMATOCRIT CONTROL

FDA 510(k)

FDA Class 2 ·Hematology

TROJAN(TM) Her Pleasure Warming male natural rubber latex condom with warming lubricant

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

Trojan Chain Reaction Personal Lubricant

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

HemoTrol WB - Low, HemoTrol WB - Normal, HemoTrol WB - High

FDA 510(k)

FDA Class 2 ·Hematology

APPLICATORS FOR AFTERLOADING BRACHYTHERAPY

FDA 510(k)

FDA Class 2 ·Radiology

Trojan™ Ultra Ribbed Ecstasy latex condom with lubricant (Trojan™ Ultra Ribbed Ecstasy)

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology