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ST JUDE MEDICAL INC

WORKMATE CLARIS · Cardiovascular

510(k): 0 Recall: 0 UDI: 29 MAUDE: 10 Class.: 63

UDI Registrations (29)

WorkMate Claris™

System - Display Plus

WorkMate Claris™

IBP Cable, For Use With Smiths Medical NovaTrans II™ MX860

WorkMate Claris™

IBP Cable, For Use With Utah Medical Deltran™ II

WorkMate Claris™

Cart 24 Inch

WorkMate Claris™

Software Upgrade Kit

WorkMate Claris™

IBP Cable, For Use With Edwards Lifesciences TruWave

WorkMate Claris™

IBP Cable, For Use With Smiths Medical LogiCal™ MX960

WorkMate Claris™

ECG Cable Set, Radiolucent

WorkMate Claris™

Amplifier

WorkMate Claris™

IBP Cable, For Use With Argon DTXPlus™

WorkMate Claris™

System Printer

WorkMate Claris™

IBP Cable For Use With ICU Medical Transpac IV

WorkMate Claris™

System

WorkMate Claris™

IBP Cable, For Use With Navilyst Medical Namic™ Perceptor™ DT

WorkMate Claris™

System Printer

WorkMate Claris™

Software Upgrade Kit

WorkMate Claris™

Z440 Software Upgrade Kit

WorkMate Claris™

Cable Kit, 15m

WorkMate Claris™

IBP Cable, For Use With Merit Medical Meritrans™

WorkMate Claris™

Power Kit, 110 Compatible with St. Jude Medical Electrophysiology Products

WorkMate Claris™

Software Upgrade Kit v.F

WorkMate Claris™

IBP Cable, For Use With Smiths Medical TranStar™ MX950

WorkMate Claris™

Cable Kit, 10 m

WorkMate Claris™

Display Workstation

WorkMate Claris™

Software Upgrade Kit

WorkMate Claris™

System

WorkMate Claris™

System Cart 48 Inch

WorkMate Claris™

Software Upgrade Kit

WorkMate Claris™

Display Plus Amplifier

MAUDE Adverse Events (10)

Injury
20200928
Injury
20200725
Injury
20200624
Injury
20200519
Injury
20200513
Injury
20200509
Injury
20200427
Injury
20200427
Injury
20200406
Injury

FDA Classification (63)

Cpr Aid Feedback Device (No Software)

Cardiovascular

Dilator, Vessel, For Percutaneous Catheterization

Cardiovascular

Predictive Indicator For Long-Term Cardiovascular Outcomes

Cardiovascular

Catheter, Angioplasty, Peripheral, Transluminal, Dual-Balloon

Cardiovascular

Pulse Oximeter For Over-The-Counter Use

Cardiovascular

Introducer, Catheter

Cardiovascular

Catheter, Oximeter, Fiber Optic, Reprocessed

Cardiovascular

Transducer, Blood-Pressure, Extravascular

Cardiovascular

Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type

Cardiovascular

Low Patient Acuity Monitoring System

Cardiovascular

Nonabsorbable Expanded Polytetrafluoroethylene Surgical Suture For Chordae Tendinae Repair Or Replacement

Cardiovascular

Outpatient Cardiac Telemetry

Cardiovascular

Apical Closure Device

Cardiovascular

Filter, Intravascular, Cardiovascular

Cardiovascular

Cardiovascular Surgical Instruments Tray

Cardiovascular

Digital Angiography Tray

Cardiovascular

Pulse-Generator, Pacemaker, External

Cardiovascular

Ultrasonic Body Composition Analyzer

Cardiovascular

Coronary Mechanical Thrombectomy With Aspiration

Cardiovascular

Catheters, Transluminal Coronary Angioplasty, Percutaneous

Cardiovascular

Bag, Polymeric Mesh, Pacemaker

Cardiovascular

Transducer, Heart Sound

Cardiovascular

Central Venous Catheter Tray

Cardiovascular

Septostomy Catheter, Reprocessed

Cardiovascular

Oximeter, Tissue Saturation

Cardiovascular

Catheter, Intravascular, Diagnostic

Cardiovascular

Ballistocardiograph

Cardiovascular

Percutaneous Catheter For Cutting Or Splitting Heart Valve Leaflets Concomitant To Transcatheter Valve Procedures

Cardiovascular

Monitor, St Segment

Cardiovascular

Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass

Cardiovascular

Software Device System For Estimation Of Cardiac Pressures

Cardiovascular

Monitor And/Or Control, Level Sensing, Cardiopulmonary Bypass

Cardiovascular

Software For Optical Camera-Based Measurement Of Pulse Rate, Heart Rate, Breathing Rate, And/Or Respiratory Rate

Cardiovascular

Dc-Defibrillator, Low-Energy, (Including Paddles)

Cardiovascular

Peripheral Mechanical Thrombectomy With Aspiration

Cardiovascular

Vectorcardiograph

Cardiovascular

Reprocessed Blood Pressure Cuff

Cardiovascular

Temporary Catheter, Embolic Protection, Transcatheter Intracardiac Procedures

Cardiovascular

Optical Coherence Tomography, Intravascular Catheter

Cardiovascular

Holder, Heart-Valve, Prosthesis

Cardiovascular

Magnet, Test, Pacemaker

Cardiovascular

Marker, Cardiopulmonary Bypass (Vein Marker)

Cardiovascular

Catheter, Thrombus Retriever

Cardiovascular

Percutaneous Catheter, Ultrasound

Cardiovascular

Syringe, Balloon Inflation

Cardiovascular

Catheter, Intravascular Occluding, Temporary

Cardiovascular

Cannula, Catheter

Cardiovascular

Detector And Alarm, Arrhythmia

Cardiovascular

Loss Of Pulse Notification Software

Cardiovascular

Winged Intravenous Catheterization Kit

Cardiovascular

Device, Vascular, For Promoting Embolization

Cardiovascular

Cardiovascular Delivery Catheter System Positioning And Stabilization Device

Cardiovascular

Over-The-Counter Automated External Defibrillator

Cardiovascular

Suction Control, Intracardiac, Cardiopulmonary Bypass

Cardiovascular

Injector, Contrast Medium, Automatic, Reprocessed

Cardiovascular

Clip, Vascular

Cardiovascular

Oximeter, Infrared, Sporting, Aviation

Cardiovascular

Oximeter, Ear

Cardiovascular

Electrocardiograph Software For Over-The-Counter Use

Cardiovascular

Filter, Prebypass, Cardiopulmonary Bypass

Cardiovascular

Esophageal Protection Device For Use In Percutaneous Cardiac Catheter Ablation Procedures, Mechanical Deviation

Cardiovascular

Sensor, Blood-Gas, In-Line, Cardiopulmonary Bypass

Cardiovascular

Computer, Diagnostic, Programmable

Cardiovascular