Processor, Cervical Cytology Slide, Automated

FDA Pre-Market Approval

FDA Class 3 ·PREPSTAIN INSTRUMENT

TruSignal SpO2 Resusable Sensor, Sensative Skin, Adult/Pediatric/Infant/Neonate, 1M (QTY 3)

Basic UDI-DI

EU MDD · Eu Md Class 2b ·GE Healthcare Finland Oy·1 device

Conductive Garments

Basic UDI-DI

EU MDR · Eu Md Class 1 ·Everyway Medical Instrument Co., Ltd.·9 devices

Airway, Nasopharyngeal

FDA classification

FDA Class 1 ·Airway, Nasopharyngeal

Console, Heart-Lung Machine, Cardiopulmonary Bypass

FDA classification

FDA Class 2 ·Console, Heart-Lung Machine, Cardiopulmonary Bypass

CentriMag Pre-connected Pack

FDA registration

APPLIMED SA -CSSR·7 products·🇨🇭 Switzerland

SARNS 8000 MODULAR PERFUSION SYSTEM

FDA registration

TERUMO CARDIOVASCULAR SYSTEMS CORPORATION·7 products·🇺🇸 United States

CentriMag Pre-connected Pack

FDA registration

THORATEC CORP.·7 products·🇺🇸 United States

ABBOTT

FDA registration

CENTERPIECE S. DE R.L DE C.V (sterilization site)·7 products·🇲🇽 Mexico

Remote Or Wearable Patient Monitoring Device For Drug Induced Qt Prolongation Monitoring

FDA classification

FDA Not Classified ·Remote Or Wearable Patient Monitoring Device For Drug Induced Qt Prolongation Monitoring

TQ TECNOL SAU

Importer

🇪🇸 Spain

FI20/07011

Certificate

MDD Annex II (excluding section 4)·QT Medical, Inc.·SGS FIMKO OY·1 Basic UDI-DI

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

FDA Pre-Market Approval

FDA Class 3 ·Evia HF /HF-T; Entovis HF/ HF-T ; Edora 8 HF-T; Entira 8 HF-1; Etrinsa 8 HF-T; Epyra 8 HF-T; Eluna 8 HF-T; Edora 8HF-T Q

Defibrillator, Implantable, Dual-Chamber

FDA Pre-Market Approval

FDA Class 3 ·Ilivia 7 HF-T, Intica 7/5 HF-T, Acticor 7 HF-T, Rivacor 7/5/3 HF-T, Ilivia 7 HF-T QP, Initca 7 HF-T QP, Acticor 7 HF-T Q

Sarns™ Modular Perfusion System 8000

FDA UDI

Terumo Cardiovascular Systems Corporation·00886799000212·Cardioplegia Monitor

Sarns™ Modular Perfusion System 8000

FDA UDI

Terumo Cardiovascular Systems Corporation·00886799001721·Lamp Long 33"

Sarns™ Modular Perfusion System 8000

FDA UDI

Terumo Cardiovascular Systems Corporation·00886799000229·CDI 500 Comm module for TCVS Sarns 8000

Sarns™ Modular Perfusion System 8000

FDA UDI

Terumo Cardiovascular Systems Corporation·00886799000342·Flow meter

Sarns™ Modular Perfusion System 8000

FDA UDI

Terumo Cardiovascular Systems Corporation·00886799000236·Line Occluder

Advena Limited

Authorized representative

🇲🇹 Malta·467 Manufacturers·13717 Devices