AEQUALIS FLEX REVIVE Shoulder System

FDA 510(k)

FDA Class 2 ·Orthopedic

VIDAS TOXO IGG AVIDITY

FDA 510(k)

FDA Class 2 ·Microbiology

PRISMA DISPOSABLE ENDO-OCULAR PROBE

FDA 510(k)

FDA Class 2 ·Ophthalmic

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

HIGH MOLECULAR WEIGHT KININOGEN(HMWK) DEF PLASMA

FDA 510(k)

FDA Class 2 ·Hematology

TURNPIKE CATHETER

FDA 510(k)

FDA Class 2 ·Cardiovascular

INCSTAR'S DANDELION ALLERGEN DISC

FDA 510(k)

FDA Class 2 ·Immunology

OZARK 46

FDA 510(k)

FDA Class 2 ·Dental

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

VITEK 2 AST-GN Tobramycin (</=1->/= 16 ug/mL); VITEK 2 AST-Gram Negative Tobramycin (</=1->/=16 ug/mL)

FDA 510(k)

FDA Class 2 ·Microbiology

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

SIGMA CALCIUM REAGENT

FDA 510(k)

FDA Class 2 ·Clinical Chemistry