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

FDA Pre-Market Approval

FDA Class 3 ·CRT-D Resynchronization Devices: COGNIS, ENERGEN, PUNCTUA, INCEPTA, ORIGEN, INOGEN, DYNAGEN, AUTOGEN, RESONATE, MOMENTUM

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·Pacemaker Devices - ADVANTIO, INGENIO, VITALIO, FORMIO, ESSENTIO, ACCOLADE, PROPONENT, (INSIGNIA and ALTRUA 2 supported

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·Entrant VR ICD, Entrant DR ICD, Gallant VR ICD, Gallant DR ICD Neutrino NxT VR ICD, Neutrino NxT DR ICD

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·Avant, Gallant, Entrant, Neutrino NxT Family of ICDs

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·Avant, Neutrino NxT, Gallant, Entrant, Ellipse, Fortify Assura

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·Avant, Entrant, Fortify, Fortify Assura, Gallant, Neutrino NxT

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·LATITUDE™ NXT Patient Management System, LATITUDE Wave Communicator

SIGNET DXIS DIRECT X-RAY IMAGING SYSTEM

FDA 510(k)

FDA Class 2 ·Dental

PHILIPS HERCEPTEST DIGITAL SCORE

FDA 510(k)

FDA Class 2 ·Hematology

Abon Biopharm(Hangzhou) Co., Ltd

Manufacturer

🇨🇳 China·123 Basic UDI-DIs·123 Devices·1 Importer·TÜV SÜD Product Service GmbH, INSTITUT PRO TESTOVÁNI A CERTIFIKACI, a. s. (INSTITUTE FOR TESTING AND CERTIFICATION) merged with ex-NB 1390, INSTITUT PRO TESTOVÁNI A CERTIFIKACI, a. s. (INSTITUTE FOR TESTING AND CERTIFICATION) merged with ex-NB 1390, GMED SAS, and GMED SAS

Coach Services Inc. dba Kate Spade c/o Soluciones XB Mexico, S. De R.L. De C.V.

FDA registration

Coach Services Inc. dba Kate Spade c/o Soluciones XB Mexico, S. De R.L. De C.V.·1 product·🇲🇽 Mexico

Coach Services Inc. dba Kate Spade c/o Soluciones XB Mexico, S. De R.L. De C.V.

FDA registration

Coach Services Inc. dba Kate Spade c/o Soluciones XB Mexico, S. De R.L. De C.V.·1 product·🇲🇽 Mexico

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·Avant VR, Avant DR, Neutrino NxT VR, Neutrino NxT DR, Gallant VR, Gallant DR, Entrant VR, Entrant DR, Ellipse VR, Ellips

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·Avant™, Neutrino™ NxT, Gallant™, and Entrant™ (NGQ) ICDs and CRT-Ds DF-1 Model Expansion

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·Current, Current Accel, Current+, Ellipse, Fortify, Fortify, Assura, Epic/Epic+, Atlas/II/+, Avant, Gallant, Entrant, Ne

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·Avant™, Neutrino™ NxT, Gallant™, and Entrant™ (NGQ) ICDs and CRT-Ds DF-1 Model Expansion

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

FDA Pre-Market Approval

FDA Class 3 ·Avant™, Neutrino™ NxT, Gallant™, and Entrant™ (NGQ) ICDs and CRT-Ds DF-1 Model Expansion

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+

ErigoPro

FDA registration

HOCOMA AG·3 products·🇨🇭 Switzerland

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

FDA Pre-Market Approval

FDA Class 3 ·Avant HF, Entrant HF, Gallant HF, Neutrino NxT HF