IONTOPHORESIS DEVICE

FDA 510(k)

FDA Class 2 ·Physical Medicine

LASER MIRROR

FDA 510(k)

CSPI PREMIUM SURGICAL ASPIRATOR

FDA 510(k)

PTC-6 AND PTC-8 PERCUTANEOUS CHOLANGIOGRAPHY

FDA 510(k)

FDA Class 1 ·General, Plastic Surgery

BONE MARROW BIOPSY PROCEDURE TRAY

FDA 510(k)

FDA Class 1 ·General, Plastic Surgery

GASTROINTESTINAL TUBE AND ACCESSORIES

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Steerable Intracardiac Catheter Introducer Kit and Transseptal Needle

FDA 510(k)

FDA Class 2 ·Cardiovascular

ESP EMERGENCY CARE KIT

FDA 510(k)

LIFE-LINE(TM) VASCULAR ACCESS SYSTEM

FDA 510(k)

FDA Class 2 ·General Hospital

MODIFICATION TO:XCEED NITINOL SELF-EXPANDING TRANSHEPATIC BILIARY STENT SYSTEM, MODELS 14819, 14820, 14821, 14822, 14822

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

OMNILINK .018 BILIARY STENT SYSTEM

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

MEDTRONIC AVE BRIDGE CONSTANT BILIARY STENT SYSTEM OR ('CONSTANT

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

MODIFICATION TO BRIDGE SELF-EXPANDING BILIARY STENT DELIVERY SYSTEM (BRIDGE SE)

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

PEEK CEMENT RESTRICTOR X-BOX

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Monarch eTNS System

FDA 510(k)

FDA Class 2 ·Neurology

PRIMUS STENT AND DELIVERY SYSTEM

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

B·R·A·H·M·S sFlt-1/ PlGF KRYPTOR Test System

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

CD HORIZON SPINAL SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

LIFESTENT SDS BILIARY ENDOPROSTHESIS, LIFESTENT XL SDS BILIARY ENDOPROSTHESIS

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

INRATIO2 PI/NR MONITORING SYSTEM; INRATIO PT/INR TEST STRIP

FDA 510(k)

FDA Class 2 ·Hematology