MVR™ Venous Reservoir Bag 800 mL; MVR™ Venous Reservoir Bag 1600 mL; MVR™ Venous Reservoir Bag with Cortiva™ BioActive Surface 800 mL; MVR™ Venous Reservoir Bag with Cortiva™ BioActive Surface 1600 mL

FDA 510(k)

FDA Class 2 ·Cardiovascular

Attain Command + SureValve Delivery System, Attain Select II + SureValve delivery system

FDA 510(k)

FDA Class 2 ·Cardiovascular

LINQ II Insertable Cardiac Monitor, CareLink SmartSync LINQ II ICM Application

FDA 510(k)

FDA Class 2 ·Cardiovascular

Medtronic Model 5392 External Pulse Generator (EPG)

FDA 510(k)

FDA Class 2 ·Cardiovascular

Affinity Fusion Oxygenator with Balance Biosurface, Affinity Fusion Oxygenator with Cardiotomy/Venous Reservoir and Balance Biosurface, Affinity Fusion Oxygenator with Cortiva Biosurface, Affinity Fusion Oxygenator with Cortiva BioActive Surface & Cardiotomy/Venous Reservoir

FDA 510(k)

FDA Class 2 ·Cardiovascular

MYOtherm XP Cardioplegia Delivery System with Cortiva BioActive Surface, MYOtherm XP Cardioplegia Delivery System Uncoated

FDA 510(k)

FDA Class 2 ·Cardiovascular

SelectSite C304 Deflectable Catheter System, C315 Delivery System

FDA 510(k)

FDA Class 2 ·Cardiovascular

FlexCath Contour™ Steerable Sheath

FDA 510(k)

FDA Class 2 ·Cardiovascular

BIO-CONSOLE 560 EXTRACORPOREAL BLOOD PUMPING CONSOLE

FDA 510(k)

FDA Class 2 ·Cardiovascular

LINQ II Insertable Cardiac Monitor

FDA 510(k)

FDA Class 2 ·Cardiovascular

Marinr Steerable Intracardiac Electrode Catheter, StableMapr Steerable Intracardiac Electrode Catheter, Torqr Intracardiac Electrode Catheter, Soloist Intracardiac Electrode Catheter

FDA 510(k)

FDA Class 2 ·Cardiovascular

SelectSite C304 Deflectable Catheter System (C304); C315 Delivery System (C315)

FDA 510(k)

FDA Class 2 ·Cardiovascular

FlexCath Advance Steerable Sheath and Dilator

FDA 510(k)

FDA Class 2 ·Cardiovascular

ATTAIN COMMAND 6250 LEFT HEART DELIVERY SYSTEMS AND GUIDE CATHETERS FOR LEFT HEART DELIVERY

FDA 510(k)

FDA Class 2 ·Cardiovascular

TYRX Neuro Absorbable Antibacterial Envelope (Medium), TYRX Neuro Absorbable Antibacterial Envelope (Large)

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Bio-Medicus Life Support Catheter and Introducer

FDA 510(k)

FDA Class 2 ·Cardiovascular

PRESSURE DISPLAY BOX,DLP DISPOSABLE PRESSURE DISPLAY SETS-NON STERILE VERSIONS

FDA 510(k)

FDA Class 2 ·Cardiovascular

NTX100 Tonic Motor Activation (NTX100 ToMAc) System

FDA 510(k)

FDA Class 2 ·Neurology

MIT ONE STEP PREGNANCY TEST

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

PROASIA, MODEL L4501

FDA 510(k)

FDA Class 2 ·Physical Medicine