Indicator, Sterilization

FDA classification

FDA Class 2 ·Indicator, Sterilization

Leadless Cardiac Resynchronization Therapy (Crt)

FDA classification

FDA Class 3 ·Leadless Cardiac Resynchronization Therapy (Crt)

Instrument, Prosthesis Modification For Ossicular Replacement Surgery, Non-Sterile

FDA classification

FDA Class 1 ·Instrument, Prosthesis Modification For Ossicular Replacement Surgery, Non-Sterile

Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)

FDA classification

FDA Class 2 ·Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)

Restraint, Patient, Conductive

FDA classification

FDA Class 1 ·Restraint, Patient, Conductive

Drug Eluting Permanent Left Ventricular (Lv) Pacemaker Electrode

FDA classification

FDA Class 3 ·Drug Eluting Permanent Left Ventricular (Lv) Pacemaker Electrode

Pacemaker/Icd/Crt Non-Implanted Components

FDA classification

FDA Class 3 ·Pacemaker/Icd/Crt Non-Implanted Components

Implantable Cardioverter Defibrillator (Non-Crt)

FDA classification

FDA Class 3 ·Implantable Cardioverter Defibrillator (Non-Crt)

Ldt, Approved By Nys Clep

FDA classification

FDA Not Classified ·Ldt, Approved By Nys Clep

Ivd Offered As Ldt, Not An Ldt Or Under A Targeted Enforcement Discretion Policy Described In Preamble To Ldt Final Rule

FDA classification

FDA Not Classified ·Ivd Offered As Ldt, Not An Ldt Or Under A Targeted Enforcement Discretion Policy Described In Preamble To Ldt Final Rule

Drug Eluting Permanent Right Ventricular (Rv) Or Right Atrial (Ra) Pacemaker Electrodes

FDA classification

FDA Class 3 ·Drug Eluting Permanent Right Ventricular (Rv) Or Right Atrial (Ra) Pacemaker Electrodes

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA classification

FDA Class 3 ·Implantable Pulse Generator, Pacemaker (Non-Crt)

Ldt, Not Under A Targeted Enforcement Discretion Policy Described In Preamble To Ldt Final Rule

FDA classification

FDA Not Classified ·Ldt, Not Under A Targeted Enforcement Discretion Policy Described In Preamble To Ldt Final Rule

Modified Version Of Another Manufacturer’S Fda-Authorized Test Within Scope Described In Preamble To Ldt Final Rule

FDA classification

FDA Not Classified ·Modified Version Of Another Manufacturer’S Fda-Authorized Test Within Scope Described In Preamble To Ldt Final Rule

Ldt, Unmet Need Within An Integrated Healthcare System

FDA classification

FDA Not Classified ·Ldt, Unmet Need Within An Integrated Healthcare System

Permanent Defibrillator Electrodes

FDA classification

FDA Class 3 ·Permanent Defibrillator Electrodes

Ivd Offered As Ldt, First Marketed Before May 6, 2024, Not Modified Beyond Scope Described In Preamble To Ldt Final Rule

FDA classification

FDA Not Classified ·Ivd Offered As Ldt, First Marketed Before May 6, 2024, Not Modified Beyond Scope Described In Preamble To Ldt Final Rule

Television Or Monitor, Non-Crt, Non-Medical, Video Display

FDA classification

FDA Not Classified ·Television Or Monitor, Non-Crt, Non-Medical, Video Display

Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P)

FDA classification

FDA Class 3 ·Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P)

Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D)

FDA classification

FDA Class 3 ·Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D)