SleepImage System

FDA 510(k)

FDA Class 2 ·Anesthesiology

LIFE+CEL BATTERY

FDA 510(k)

FDA Class 2 ·Cardiovascular

ZESPIN SI Joint Fusion System, Paeon Posterior Cervical Fixation System, Paeon Anterior Cervical Plate System, Spinema Lumbar Plate System

FDA 510(k)

FDA Class 2 ·Orthopedic

Maven Patient-Specific Instrumentation

FDA 510(k)

FDA Class 2 ·Orthopedic

COBE OPTIMIN HOLLOW FIBER MEMBRANE OXYGENATOR

FDA 510(k)

FDA Class 2 ·Cardiovascular

MegaVac Mechanical Thrombectomy System

FDA 510(k)

FDA Class 2 ·Cardiovascular

SI-TECHNOLOGY® SI-DESIS® X™ Sacroiliac Joint Fusion System

FDA 510(k)

FDA Class 2 ·Orthopedic

POCKETED WRAPS #3009 A,B,C

FDA 510(k)

FDA Class 2 ·General Hospital

Getinge Assured MI Steam Migrating Integrator

FDA 510(k)

FDA Class 2 ·General Hospital

TightRail Guardian Motorized Dilator Sheath, 9 French (575-009); TightRail Guardian Motorized Dilator Sheath, 11 French (575-011); TightRail Guardian Motorized Dilator Sheath, 13 French (575-013)

FDA 510(k)

FDA Class 2 ·Cardiovascular

STN PROBE

FDA 510(k)

FDA Class 2 ·Radiology

JAWS(TM) Nitinol Staple System

FDA 510(k)

FDA Class 2 ·Orthopedic

LIFECARE EXHALATION VALVE #06-699

FDA 510(k)

FDA Class 2 ·Anesthesiology

DENTAL IMPLANT SYSTEM

FDA 510(k)

FDA Class 2 ·Dental

GYREX PRIMA 1TG 1.0T MRI SYSTEM

FDA 510(k)

FDA Class 2 ·Radiology

STEALTHSTATION SYSTEM THREE DIMENSIONAL C-ARM INTERFACE

FDA 510(k)

FDA Class 2 ·Neurology

Rapid SDH

FDA 510(k)

FDA Class 2 ·Radiology

Nellcor Bedside SpO2 Patient Monitoring System

FDA 510(k)

FDA Class 2 ·Cardiovascular

PRISMA CFM (CONTINUOUS FLUID MANAGEMENT SYSTEM)

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

OPTIMUM GP (OXYGEN PERMEABLE) DAILY WEAR CONTACT LENSES

FDA 510(k)

FDA Class 2 ·Ophthalmic