Lithotriptor, Extracorporeal Shock-Wave, Urological

FDA Pre-Market Approval

FDA Class 2 ·GENESTONE 190 LITHOTRIPTER

DEGANIA SILICONE INDENTI LOOPS

FDA 510(k)

FDA Class 2 ·Cardiovascular

SILCLEAR TUBING

FDA 510(k)

FDA Class 2 ·General Hospital

AQUARIUS Gastrostomy Replacement Tube

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

AQUARIUS LOW PROFILE GASTROSTOMY FEEDING TUBE

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

SILCLEAR TUBING (MODIFICATION)

FDA 510(k)

FDA Class 2 ·General Hospital

COUDE/ OR TIEMANN

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

DEGANIA SILICONE IDENTI LOOPS

FDA 510(k)

FDA Class 2 ·Cardiovascular

ALL SILICONE FOLEY CATHETER, 2-WAY, 3-WAY, WITH TEMPERATURE SENSOR

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

AQUARIUS NASAL FEEDING TUBE

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

GASTROSTOMY REPLACEMENT TUBE, MODEL 253

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

ALPHA-THAL SCREEN 20 TEST KIT & 100 KIT

FDA 510(k)

FDA Class 2 ·Hematology

ALPHA-THAL SCREEN TM CONTROL

FDA 510(k)

FDA Class 2 ·Hematology

ROMEO POSTERIOR OSTEOSYNTHESIS SYSTEM PREBENT CROSS-CONNECTORS; PREBENT RODS

FDA 510(k)

FDA Class 2 ·Orthopedic

HLA-2000

FDA 510(k)

FDA Class 2 ·Cardiovascular

TEMPERATURE SENSOR CATHETER

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

AQUARIUS EXTENSION FEEDING SET

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Stylus

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

LOW PROFILE GASTROSTOMY FEEDING TUBE OR GASTROTOMEY BUTTON

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

SAGE Vitrification Kit (ART-8025 and ART-8026) / SAGE Vitrification Warming Kit (ART-8030 and ART-8031)

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology