Freestyle Freedom Blood Glucose Monitoring Sytem

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

NON-STERILE KIRSCHNER WIRES AND STEINMANN PINS, MODELS #'S 290-101/160, 290-201/216, 290-060/330, 290-161/220

FDA 510(k)

FDA Class 2 ·Orthopedic

DURAMAX .035 BILIARY STENT SYSTEM, MODELS DML0718-80, DML0718-135, DML0818-80, DML0818-135, DML0918-80, DML0918-135, DML

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

FreeStyle InsuLinx Blood Glucose Monotioring System

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

FreeStyle Lite Blood Glucose Monitoring System

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

SYNTEC-TAICHUNG NON-STERILE UNREAMED INTERLOCKING NAIL SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

ADMIRAL .035 DILATATION CATHETER, MODELS ADL0720-80,ADL0720-135,ADL0820-80, ADL0820-135,ADL0920-80,ADL0920-135,ADL1020-0

FDA 510(k)

FDA Class 2 ·Cardiovascular

DURAMAX .018 BILIARY STENT SYSTEM

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

SYNTEC-TAICHUNG NON-STERILE INTERLOCKING NAIL SYSTEM, MODEL:HUMERUS:256-000/280, FEMUR:274-000/870, TIBIA:249-300/420 25

FDA 510(k)

FDA Class 2 ·Orthopedic

SYNTEC-TAICHUNG NON-STERILE BONE PLATE AND SCREW IMPLANTS, MODEL#'S 222020-248120, 240050-240980, 241130-246620, 4240420

FDA 510(k)

FDA Class 2 ·Orthopedic

SYNTEC-TAICHUNG NON-STERILE DHS/DCS PLATE SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

SYNTEC-TAICHUNG NON-STERILE TITANIUM ALLOY MINI-PLATE

FDA 510(k)

FDA Class 2 ·Orthopedic

FLEXI-STAT REUSABLE FINGER CLIP SPO2 SENSORS (NELLCOR-COMPATIBLE),(BCI-COMPATIBLE), (DATEX-COMPATIBLE)

FDA 510(k)

FDA Class 2 ·Cardiovascular

FLEXI-STAT DISPOSABLE NON-ADHESIVE SPO2 SENSORS, (NELLCOR-COMPATIBLE), (BCI-COMPATIBLE), (DATEX-COMPATIBLE)

FDA 510(k)

FDA Class 2 ·Cardiovascular

FIBEROPTIC CATHETER

FDA 510(k)

FDA Class 2 ·Cardiovascular

ROTARY* POWERED SCALPEL

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

ENVISEN NELLCOR, BCI, NONIN, CSI, HP/PHILIPS, DATEX-OHMEDA COMPATIBLE DISPOSABLE AND REUSABLE SPO2 SENSORS

FDA 510(k)

FDA Class 2 ·Cardiovascular

SkyPulse

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

LightWalker Laser System Family

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

ACE HEMOGLOBIN A1C REAGENT, MODEL ACI-21, HEMOGLOBIN A1C CALIBRATORS, MODEL S2-72, HEMOGLOBIN A1C CONTROLS, MODEL C2-72

FDA 510(k)

FDA Class 2 ·Hematology