ST360 DEGREES SPINAL FIXATION SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

X4

FDA 510(k)

FDA Class 2 ·Neurology

iLet® ACE Pump

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

DYNESYS TOP-LOADING SPINAL SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

Kogent Disposable Copper Forceps, Kogent Disposable Irrigating Copper Forceps, Kogent Disposable Illuminating Copper Forceps

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

NAVIGATOR APPLICATIONS SUITE

FDA 510(k)

FDA Class 2 ·Anesthesiology

Direxion and Direxion HI-FLO Torqueable Microcatheters

FDA 510(k)

FDA Class 2 ·Cardiovascular

HUMID-VENT HEPA

FDA 510(k)

FDA Class 2 ·Anesthesiology

Uroject12 Syringe Lever

FDA 510(k)

FDA Class 2 ·General Hospital

CODMAN DURAL GRAFT IMPLANT, MODELS 80-1471, 80-1472, 80-1473, 80-1474, 80-1475, 80-1476, 80-1477, 80-1478, 80-1480, 80-1

FDA 510(k)

FDA Class 2 ·Neurology

NAVIGATOR APPLICATIONS SUITE

FDA 510(k)

FDA Class 2 ·Anesthesiology

GE DATEX-OHMEDA S/5 ADU CARESTATION

FDA 510(k)

FDA Class 2 ·Anesthesiology

MICROSOFT AMALGA UIS IMAGE PROCESSING MODULE

FDA 510(k)

FDA Class 2 ·Radiology

INVIA MOTION NEGATIVE PRESSURE WOUND THERAPY SYSTEM

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

HYBRID ANTERIOR CERVICAL PLATE SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

Direxion Torqueable Microcatheter

FDA 510(k)

FDA Class 2 ·Cardiovascular

APNEA RISK EVALUATION SYSTEM (ARES)

FDA 510(k)

FDA Class 2 ·Anesthesiology

X10 HEADSET WITH X-SERIES BASIC SOFTWARE, X24 HEADSET WITH X-SERIES BASIC SOFTWARE

FDA 510(k)

FDA Class 2 ·Neurology

APDL Drainage Catheter System, Flexima APDL Drainage Catheter System, Flexima APDL Drainage Catheter System Kit with Dissolving Tip, Flexima APDL Drainage Catheter System with Dissolving Tip, Flexima APD Drainage Catheter System, Flexima APD Drainage Catheter System Kit, Flexima APD Drainage Catheter System with Dissolving Tip, Flexima APD Drainage Catheter System Kit with Dissolving Tip, Flexima Quickstick Drainage Catheter System, vanSonnenberg Drainage Cateter System, vanSonnenberg

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

SecurAcath

FDA 510(k)

FDA Class 2 ·General Hospital