Sphincterotome

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

TEMPERATURE DIAGNOSTIC ACCESSORY

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

A/C ENZYMATIC VITAMIN B6 ASSAY

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

MODIFICATION TO: NUVASIVE SPHERX SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

Electrosurgical System (Electrosurgical Generator with Bipolar polypectomy snare combination and Single use electrosurgical knife combination accessories)

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

POLYSTAN HEART-LUNG MACHINE SYSTEM

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

TEZO TITANIUM CAGE FAMILY

FDA 510(k)

FDA Class 2 ·Orthopedic

MRI Patient Monitor TeslaDUO

FDA 510(k)

FDA Class 2 ·Cardiovascular

DV-300 Aspirator

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

TANGORS MULTIFUNCTIONAL POSTERIOR SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

Surgical Gown (Sterile), Surgical Gown (Non-sterile)

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

SPACELABS P.C. CARDIAC OUTPUT/PRESSURE MODULE

FDA 510(k)

FDA Class 2 ·Cardiovascular

Stryker SternalPlate System

FDA 510(k)

FDA Class 2 ·Orthopedic

Disposable Stone Extraction basket

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

ThermArt (Model IR-EFT)

FDA 510(k)

FDA Class 2 ·General Hospital

Ultrasonic Scaler (WD-JY-B002,WD-JY-W001,WD-JY-R003,WD-JY-G004,WD-JY-B003,WD-JY-C006,WD-JY-M0014, WD-JY-N0015,WD-JY-N0016,WD-JY-N0017,WD-JY-E007, WD-JY-F008,WD-JY-A005,WD-JY-H009,WD-JY-I0011, WD-JY-K0012,WD-JY-K0013,WD-JY-K0014, WD-JY-L0013,WD-JY-L0014,WD-JY-L0015, WD-JY-L0016,WD-JY-L0017)

FDA 510(k)

FDA Class 2 ·Dental

Momentum™ Posterior Spinal Fixation System

FDA 510(k)

FDA Class 2 ·Orthopedic

ELECTRO-NERVE STIMULATOR TENS MODEL BMLS02-2

FDA 510(k)

FDA Class 2 ·Neurology

Volumetric Specimen Imager

FDA 510(k)

FDA Class 2 ·Radiology

MagnetOs MIS

FDA 510(k)

FDA Class 2 ·Orthopedic