Quantum PureFlow Centrifugal Blood Pump CP37, Quantum PureFlow Centrifugal Blood Pump CP22

FDA 510(k)

FDA Class 2 ·Cardiovascular

Tyto Stethoscope

FDA 510(k)

FDA Class 2 ·Cardiovascular

CITOP10 GUIDEWIRE, 0.014(1.4MM TIP), CITOP6 GUIDEWIRE, 0.014(1.0MM TIP), CITOP SUPPORT ACCESSORY, 0.023(126CM)

FDA 510(k)

FDA Class 2 ·Cardiovascular

Nerivio

FDA 510(k)

FDA Class 2 ·Neurology

MICROSTREAM FILTERLINE ICU

FDA 510(k)

FDA Class 2 ·Anesthesiology

PRECISION RXI ANALOG X-RAY SYSTEM

FDA 510(k)

FDA Class 2 ·Radiology

THD Anopress with THD SensyProbe

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

MODIFICATION TO WBR, MODEL HR

FDA 510(k)

FDA Class 2 ·Radiology

MIS Internal Hex Dental Implant System

FDA 510(k)

FDA Class 2 ·Dental

TraumaCad Mobile Release 1.0

FDA 510(k)

FDA Class 2 ·Radiology

TEETHAN 2.0

FDA 510(k)

FDA Class 2 ·Physical Medicine

DEGANIA SILICONE INDENTI LOOPS

FDA 510(k)

FDA Class 2 ·Cardiovascular

MODIFICATION TO ENVOY PATIENT MONITOR

FDA 510(k)

FDA Class 2 ·Cardiovascular

FIXION INTRAMEDULLARY NAILING SYSTEM (FIXION IM NAILING SYSTEM)

FDA 510(k)

FDA Class 2 ·Orthopedic

MIROXI

FDA 510(k)

FDA Class 2 ·Cardiovascular

DISKOM

FDA 510(k)

FDA Class 2 ·Orthopedic

BriefCase-Quantification

FDA 510(k)

FDA Class 2 ·Radiology

MILLENNIUM SERIES, INCLUDING MILLENNIUM B, B+, B2 AND BU

FDA 510(k)

FDA Class 2 ·General Hospital

MODIFICATION TO MEDIPRIME

FDA 510(k)

FDA Class 2 ·Radiology

TEMP BASIC, TEMP PREMIUM, TEMP PREMIUM FLEXIBLE, MULTISTRATUM FLEXIBLE, THERAPON, TRY-IN, BURNOUT, TRY-IN & BURNOUT

FDA 510(k)

FDA Class 2 ·Dental