TempSure System

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

OXFORD EXTERNAL FIXATION SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

GYRUS ACMI PK BUTTON ELECTRODE

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

HELI-TECH RETRIEVAL BASKET

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

GC IV CORONARY GUIDING CATHETER

FDA 510(k)

FDA Class 2 ·Cardiovascular

ACCESS SURGICAL INT'L INC. ENDOSCOPIC SURG. INST.

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

POSITIVE PLACEMENT ANETHESIA KIT

FDA 510(k)

FDA Class 2 ·Anesthesiology

TORNIER CINCH KNOTLESS FIXATION IMPLANT SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

MODIFICATION TO PARIETEX COMPOSITE (PCO) MESH

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

EXPEDIUM SPINE SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

Symmetric Total Knee System

FDA 510(k)

FDA Class 2 ·Orthopedic

SARNS SM03 MEMBRANE OXYGENATOR, MODIFICATION

FDA 510(k)

FDA Class 2 ·Cardiovascular

Retitrack

FDA 510(k)

FDA Class 2 ·Ophthalmic

TOTAL BILIRUBIN REAGENT SET

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

MEDTRONIC 5F & 9F ZUMA GUIDING CATHETERS

FDA 510(k)

FDA Class 2 ·Cardiovascular

LUMENA FH HAIR REMOVAL SYSTEM

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

QUANTEX FERRITIN

FDA 510(k)

FDA Class 2 ·Immunology

INFINITY PLUS ELECTROTHERAPY SYSTEM

FDA 510(k)

FDA Class 2 ·Physical Medicine

BREATH TRACKER(TM) MODEL 1800 CAN-O-GAUGE

FDA 510(k)

FDA Class 2 ·Anesthesiology

QUANTRA

FDA 510(k)

FDA Class 2 ·Radiology