Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·Assurity MRI and Endurity MRI Pacemakers, Tendril MRI Lead, MRI Activator, Merlin PCS Programmer Software

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

FDA Pre-Market Approval

FDA Class 3 ·Anthem, Allure/RF, Allure Quadra/RF family of CRT-Ps

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·ASSURITY, ASSURITY+, ENDURITY, ACCENT FAMILY OF PACEMAKERS

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·CURRENT, CURRENT ACCEL, CURRENT+, ELLIPSE, FORTIFY, FORTIFY ASSURA, EPIC/EPIC+, ATLAS/II/+ FAMILY OF ICD'S

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

FDA Pre-Market Approval

FDA Class 3 ·PROMOTE/+/RF/Q, PROMOTE ACCEL, PROMOTE QUADRA, UNIFY, UNIFY ASSURA, UNIFY QUADRA, QUADRA ASSURA, EPIC+/HF/HF+/II HF/II+

HEADSTAR

FDA UDI

HEADSTAR MEDICAL PRODUCTS CO., LTD.·04711402234158·HP-2557 Nebulizer Kit(Adult) includes: nebulize...

HEADSTAR

FDA UDI

HEADSTAR MEDICAL PRODUCTS CO., LTD.·04711402234165·HP-2558 Nebulizer Kit(Child) includes: nebulize...

System, Hemodynamic, Implantable

FDA Pre-Market Approval

FDA Class 3 ·CARDIOMEMS HF SYSTEM

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

FDA Pre-Market Approval

FDA Class 3 ·ANTHEM, ALLURE/RF, ALLURE QUADRA/RF FAMILY OF CRT-P'S

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·ASSURITY, ASSURITY+, ENDURITY, ACCENT FAMILY OF PACEMAKERS

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

FDA Pre-Market Approval

FDA Class 3 ·PROMOTE/+/RF/Q, ACCEL/ QUADR;UNIFY ASSURA/ QUADRA, EPIC+/HF/HF+/II HF/II+ HF,ATLAS+HF/II HH/II+ H FAMILY OF CRT-D FAMILY

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·CURRENT, CURRENT ACCEL, CURRENT+, ELLIPSE, FORTIFY, FORTIFY ASSURA, EPIC/EPIC+, ATLAS/II/+ FAMILY OF ICDS

BIOMIC

FDA UDI

Giles Scientific, Inc.·00863504000217·

NExT Station; NExT Station Advanced

FDA 510(k)

FDA Class 2 ·Neurology

BE PLUS / AURA-LTM64 AMPLIFIER

FDA 510(k)

FDA Class 2 ·Neurology

NEMUS SYSTEM; NEMUS PC PERIPHERAL

FDA 510(k)

FDA Class 2 ·Physical Medicine

STM 9000 Basic, STM 9000 Standard, STM 9000 Fast, STM 9000 Ultra-Fast

FDA 510(k)

FDA Class 2 ·Neurology

NIC36 AMPLIFIER

FDA 510(k)

FDA Class 2 ·Neurology

MIZAR, BASIS BE, SANDMAN DIGITAL

FDA 510(k)

FDA Class 2 ·Neurology

BE PLUS LTM AMPLIFIER GWI AMPLIFIER

FDA 510(k)

FDA Class 2 ·Neurology