Somatic Gene Mutation Detection System

FDA Pre-Market Approval

FDA Class 3 ·therascreen PDGFRA RGQ PCR Kit

Sensis Vibe Hemo (VD15B)

FDA registration

Siemens Healthineers AG·9 products·🇩🇪 Germany

Defibrillator, Implantable, Dual-Chamber

FDA Pre-Market Approval

FDA Class 3 ·TUPOS LV/ATX & KRONOS LV-T CRT-D & COROX OWT STEROID LV PACING LEAD

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

FDA Pre-Market Approval

FDA Class 3 ·EPIC + HF, ATLAS + HF, EPIC II + HF, ATLAS II + HF CARDIAC RESYNCHRONIZATION DEFIBRILLATORS

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·VENTAK PRX AND MINI IMPLANTABLE CARDIOVERTER DEFIBRILLATORS

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·VENTAK AV, PRIZM, VITALITY, VITALITY AVT IMPLANTABLE CARDIOVERTER DEFIBRILLATORS

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

FDA Pre-Market Approval

FDA Class 3 ·CONTAK CD AND RENEWAL CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATORS

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

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

FDA Pre-Market Approval

FDA Class 3 ·CARDIAC RESYNCHRONIZATION THERAPY PACEMAKER (CRT-P) DEVICES

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

FDA Pre-Market Approval

FDA Class 3 ·MEDTRONIC CONCERTO MODEL C154DWK ICD

LONG PSM POLE MOUNT

FDA registration

GE HEALTHCARE FINLAND OY·10 products·🇫🇮 Finland

LONG PSM POLE MOUNT

FDA registration

GE Medical Systems Information Technologies - Critikon de Mexico S. de R.L. de C.V.·10 products·🇲🇽 Mexico

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

FDA Pre-Market Approval

FDA Class 3 ·CONTAK RENEWAL 3 CRT-D MODELS H170/H175, CONTAK RENEWAL 3 HE CRT-D MODELS H177/H179, AND MODEL 2845 VERSION 2.2 SOFTWARE

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

FDA Pre-Market Approval

FDA Class 3 ·EPIC AND ATLAS+ HF CRT-D SYSTEMS

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)

MedNet EC-REP IIb GmbH

Authorized representative

🇩🇪 Germany·32 Manufacturers·165 Devices

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

FDA Pre-Market Approval

FDA Class 3 ·CONTAK RENEWAL CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D)

NA

FDA UDI

GE Healthcare Finland Oy·00840682104081·

Bcr/Abl1 Monitoring Test

FDA classification

FDA Class 2 ·Bcr/Abl1 Monitoring Test

IntelliVue Patient Monitor MP5, MP5T, MP5SC SW Rev. J.20

FDA registration

Philips Electronics Ltd·13 products·🇨🇦 Canada