ACON ON CALL VIVID PAL BLOOD GLUCOSE MONITORING SYSTEM

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

SPI ELEMENT PLATFORM O 4.0 MM

FDA 510(k)

FDA Class 2 ·Dental

MODIFICATION TO ARTHROCARE ARTHROWANDS

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

MODIFICATION TO ENDOTINE RIBBON

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

MICRUS MICROCOIL DELIVERY SYSTEM, MODELS SPH, HEL, CHE, PC4, HSR, FSR, CSP, CFS, SRC, PP4, STR

FDA 510(k)

FDA Class 2 ·Neurology

NUVASIVE SPHERX II SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

ENDOSCOPE REPROCESSOR OER-PRO

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

ECHELON MICRO CATHETER, MARATHON MICRO CATHETER, NAUTICA MICRO CATHETER ULTRAFLOW HPC FLOW DIRECTED MICRO CATHETER, REBA

FDA 510(k)

FDA Class 2 ·Cardiovascular

MODEL 10-C W/LP-10A/U & OB-10A/U FOR ORAL/ENT USE

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

EVALVE STEERABLE GUIDE CATHETER

FDA 510(k)

FDA Class 2 ·Cardiovascular

OCTAVE SPEEDER SPINE

FDA 510(k)

FDA Class 2 ·Radiology

ARTHOCARE SPARTAN PEEK SUTURE IMPLANT SYSTEM; PUNCH TAP ; EXTRACTION TOOL

FDA 510(k)

FDA Class 2 ·Orthopedic

LAKONG ULTRASONIC SCALER

FDA 510(k)

FDA Class 2 ·Dental

OPIATE ENZYME IMMUNOASSAY

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

TRAGET DETACHABLE COIL

FDA 510(k)

FDA Class 2 ·Neurology

THERA-FIT

FDA 510(k)

FDA Class 2 ·Physical Medicine

EMIT CONVENIENCE PACK FOR THE COBAS MIRA PRIMIDONE

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

HEPARIN INFUSIN PUMP

FDA 510(k)

FDA Class 2 ·General Hospital

t:slim Insulin Delivery System

FDA 510(k)

FDA Class 2 ·General Hospital

KARL STORZ UNIPOLAR BALL, NEEDLE, LOOP ELECTRODES

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology