TYRX Absorbable Antibacterial Envelope (medium), TYRX Absorbable Antibacterial Envelope (large)

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

ECT DIGITAL THERMOMETER

FDA 510(k)

FDA Class 2 ·General Hospital

FlexCath Select Steerable Sheath (10 French)

FDA 510(k)

FDA Class 2 ·Cardiovascular

Medtronic Bio-Medicus Adult Cannula Kit

FDA 510(k)

FDA Class 2 ·Cardiovascular

CARDIOBLATE GEMINI SURGICAL ABLATION DEVICE

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

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

INFUSION SYRINGE SET

FDA 510(k)

FDA Class 2 ·General Hospital

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