AEQUALIS FLEX REVIVE Shoulder System

FDA 510(k)

FDA Class 2 ·Orthopedic

NOMAD (BASE UNIT/PORTABLE UNIT)

FDA 510(k)

FDA Class 2 ·Anesthesiology

URGENT PC NEUROMODULATION SYSTEM, MODELS UPC200-A AND UPC250-12

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

EnSite X EP System, Advisor VL Circular Mapping Catheter, Sensor Enabled, Advisor FL Circular Mapping Catheter, Sensor Enabled, Advisor HD Grid High Density Mapping Catheter, Senor Enabled

FDA 510(k)

FDA Class 2 ·Cardiovascular

POSSIS ANGIOJET RAPID THOMBECTOMY CATHETERS--F105 CATHETER MODEL 3030C, LF140 CATHETER MODEL 3040C

FDA 510(k)

FDA Class 2 ·Cardiovascular

TURNPIKE CATHETER

FDA 510(k)

FDA Class 2 ·Cardiovascular

INCSTAR'S DANDELION ALLERGEN DISC

FDA 510(k)

FDA Class 2 ·Immunology

AFFINITY FUSION RECIRCULATION LINE MODEL RCL841

FDA 510(k)

FDA Class 2 ·Cardiovascular

CORTISOL AND CORTISOL CALIBRATORS ON THE ACCESS IMMUNOASSAY SYSTEMS

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

CLOTRAC HEPARINASE TEST CARTIDGE (HTC) COAGULATION CONTROL

FDA 510(k)

FDA Class 2 ·Hematology

INNOVA PELVIC FLOOR STIMULATION SYSTEM

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

MODEL 8500, HAND HELD PULSE OXIMETER, MODEL 8500

FDA 510(k)

FDA Class 2 ·Cardiovascular

3M Attest Rapid Readout Biological Indicator

FDA 510(k)

FDA Class 2 ·General Hospital

FILTEK BULK FILL POSTERIOR RESTROATIVE

FDA 510(k)

FDA Class 2 ·Dental

CLARUS PHOENIX NEURO ENDOSCOPE MODEL 2160

FDA 510(k)

FDA Class 2 ·Neurology

AVVIGO'+ Multi-Modality Guidance System

FDA 510(k)

FDA Class 2 ·Cardiovascular

IMPRINT VINYL POLYSILOXANE IMPRESSION MATERIAL

FDA 510(k)

FDA Class 2 ·Dental

MODEL 2872 BIPOLAR LEAD ADAPTOR KIT

FDA 510(k)

FDA Class 2 ·Cardiovascular

RAEBBITT/EVOLUTION POWERED WHEELCHAIR

FDA 510(k)

FDA Class 2 ·Physical Medicine

P.A.S. PORT ELITE IMPLANTABLE VENOUS ACCESS SYSTEM

FDA 510(k)

FDA Class 2 ·General Hospital