AFFINITY CP CENTRIFUGAL BLOOD PUMP WITH OR WITHOUT COATING, AFFINITY CP ADAPTER

FDA 510(k)

FDA Class 2 ·Cardiovascular

REVEAL DX INSERTABLE CARDIAC MONITOR, REVEAL PATIENT ASSISTANT, MODEL(S) 9528,9538

FDA 510(k)

FDA Class 2 ·Cardiovascular

LINQ II Insertable Cardiac Monitor

FDA 510(k)

FDA Class 2 ·Cardiovascular

Reveal LINQ Insertable Cardiac Monitor

FDA 510(k)

FDA Class 2 ·Cardiovascular

HEMOSTASIS MANAGMENT SYSTEM PLUS (HMS-PLUS)

FDA 510(k)

FDA Class 2 ·Hematology

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

FDA 510(k)

FDA Class 2 ·Cardiovascular

HEPARIN ASSAY CONTROLS

FDA 510(k)

FDA Class 2 ·Hematology

REVEAL XT INSERTABLE CARDIAC MONITOR, MODEL 9529, REVEL DX INSERTABLE CARDIAC MONITOR, MODEL 9528

FDA 510(k)

FDA Class 2 ·Cardiovascular

Reveal LINQ

FDA 510(k)

FDA Class 2 ·Cardiovascular

MC2™ Two-Stage Venous Cannula; MC2X™ Three-Stage Venous Cannula

FDA 510(k)

FDA Class 2 ·Cardiovascular

Reveal LINQ

FDA 510(k)

FDA Class 2 ·Cardiovascular

Medtronic Temporary External Pacemaker 53401

FDA 510(k)

FDA Class 2 ·Cardiovascular

MEDTRONIC C315 DELIVERY CATHETER

FDA 510(k)

FDA Class 2 ·Cardiovascular

Medtronic Patient Asistant

FDA 510(k)

FDA Class 2 ·Cardiovascular

Affera Integrated Mapping System; Impedance Localization Patch Kit

FDA 510(k)

FDA Class 2 ·Cardiovascular

BIO-PROBE TRANSDUCER (ADULT)

FDA 510(k)

FDA Class 2 ·Cardiovascular

Affera Integrated Mapping System

FDA 510(k)

FDA Class 2 ·Cardiovascular

AVIVO Mobile Patient Management (MPM) System

FDA 510(k)

FDA Class 2 ·Cardiovascular

LINQ II Insertable Cardiac Monitor, Zelda AI ECG Classification System

FDA 510(k)

FDA Class 2 ·Cardiovascular

Attain Hybrid Guide Wire

FDA 510(k)

FDA Class 2 ·Cardiovascular