Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·PRISM/PRIZM 2/ CONTAK CD2/VITALITY DS/EL MODEL 2844 VERSION 3.8

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·CONTAK CD, CONTAK CD2, EASYTRAK, EASYTRAK 2, EASYTRAK 3, CONTAK RENEWAL, CONTAK RENEWAL 3

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

FDA Pre-Market Approval

FDA Class 3 ·MODELS H115 AND H119 CONTAK CD 2 (CRT-D) CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR SYSTEM

Sensor, Glucose, Invasive

FDA Pre-Market Approval

FDA Class 3 ·FREESTYLE LIBRE PRO FLASH GLUCOSE MONITORING SYSTEM

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·CONTAK CD, CONTAK CD 2, EASYTRAK, EASYTRACK 2, EASYTRAK 3, CONTAK RENEWAL, CONTAK RENEWAL 3

Defibrillator, Implantable, Dual-Chamber

FDA Pre-Market Approval

FDA Class 3 ·KRONOS LV-T CRT-D & LUMAX VR/DR/HF (-T) ICDS & CDT-DS

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

FDA Pre-Market Approval

FDA Class 3 ·CONTAK CD (MODEL 1823), CONTAK CD2 (MODEL H115, H119), RENEWAL (MODELS H135) AND RENEWAL 3 (MODELS H170,H175,H177,H179)

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·Fortify Models CD1231-40, CD1231-40Q, CD2231-40, CD2231-40Q; Fortify Assura Models CD1257-40, CD1257-40Q, CD2257-40, CD2

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

FDA Pre-Market Approval

FDA Class 3 ·CONTAK CD (MODEL 1823), CONTAK CD 2 (MODELS H115 AND H119), RENEWAL (MODEL H135), RENEWAL 3 (MODELS H170, H175, H177, A

POWRPAK REPLACEMENT BATTERIES FOR PHISIO-CONTROL LIFEPAK 5/10

FDA 510(k)

FDA Class 3 ·Cardiovascular

MEDILAS 2

FDA 510(k)

FDA Class 3 ·Unknown

NOVATHERM

FDA 510(k)

FDA Class 3 ·Obstetrics/Gynecology

OSCOR MEDICAL IMPLANTABLE PACING LEAD, RETRACTABLE

FDA 510(k)

FDA Class 3 ·Cardiovascular

MULTI-FUNCTION DEFIBRILLATION ELECTRODE

FDA 510(k)

FDA Class 3 ·Cardiovascular