THERATEST EL-ANTI-CCP/2

FDA 510(k)

FDA Class 2 ·Immunology

CONSTELLATION CATHETERS, MODEL 8031M

FDA 510(k)

FDA Class 2 ·Cardiovascular

PENTARAY NAV HIGH-DENSITY MAPPING CATHETER

FDA 510(k)

FDA Class 2 ·Cardiovascular

FRIMAP ADAPTER CONNECTOR (MAC)

FDA 510(k)

FDA Class 2 ·Cardiovascular

Reprocessed IntellaMap Orion High Resolution Mapping Catheter

FDA 510(k)

FDA Class 2 ·Cardiovascular

OPTRELL Mapping Catheter with TRUEref Technology

FDA 510(k)

FDA Class 2 ·Cardiovascular

QUANTA LITE CCP3 IGG ELISA

FDA 510(k)

FDA Class 2 ·Immunology

CONSTELLATION CATHETERS, MODEL 8039

FDA 510(k)

FDA Class 2 ·Cardiovascular

Reprocessed Advisor HD Grid Mapping Catheter, Sensor Enabled

FDA 510(k)

FDA Class 2 ·Cardiovascular

QUANTA LITE CCP ELISA

FDA 510(k)

FDA Class 2 ·Immunology

MERCATOR ATRIAL HIGH DENSITY ARRAY CATHETER MODELS, 7005, 7006, 7007, MERCATOR ATRIAL HIGH DENSITY ARRAY DEPLOYMENT KIT,

FDA 510(k)

FDA Class 2 ·Cardiovascular

CONSTELLATION MULTIPLE ELECTRODE RECORDING & PACING CATHETER

FDA 510(k)

FDA Class 2 ·Cardiovascular

Advisor™ HD Grid X Mapping Catheter, Sensor Enabled™

FDA 510(k)

FDA Class 2 ·Cardiovascular

Reprocessed PentaRay Nav eco High-Density Mapping Catheter

FDA 510(k)

FDA Class 2 ·Cardiovascular

MULTI-ANALYTE DETECTION SYSTEMS

FDA 510(k)

FDA Class 2 ·Immunology

IMMUNOSCAN CCPLUS

FDA 510(k)

FDA Class 2 ·Immunology

ENSITE ARRAY MULTI-ELECTRODE DIAGNOSTIC CATHETER

FDA 510(k)

FDA Class 2 ·Cardiovascular

Advisor HD Grid Mapping Catheter, Sensor Enabled

FDA 510(k)

FDA Class 2 ·Cardiovascular

PENTARAY® NAV ECO High Density Mapping Catheter, DECANAV® Mapping Catheter, Webster® CS Catheter with Auto ID, Webster® CS Catheter with EZ Steer Technology, Webster® CS Catheter with EZ Steer Technology with Auto ID

FDA 510(k)

FDA Class 2 ·Cardiovascular

AXSYM ANTI-CCP REAGENT, STANDARD CALIBRATOR AND CONTROL KITS, MODELS 3L91-20, 3L91-01 AND 3L91-10

FDA 510(k)

FDA Class 2 ·Immunology