Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·INCEPTA, ENERGEN, PUNCTUA AND TELIGEN ICDS

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·INCEPTA, ENERGEN, PUNCTUA AND COGNIS CRT-D

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·TELIGEN ICD

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·COGNIS CRT-D

Conductive Garments

Basic UDI-DI

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

Atp And Creatine Kinase (Enzymatic), Creatine

FDA classification

FDA Class 1 ·Atp And Creatine Kinase (Enzymatic), Creatine

Defoamer, Cardiopulmonary Bypass

FDA classification

FDA Class 2 ·Defoamer, Cardiopulmonary Bypass

Dropper, Ether

FDA classification

FDA Class 1 ·Dropper, Ether

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

FI20/07011

Certificate

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

Nadh, Phosphoglycerate Mutase, Atp (U.V.) 2,3-Diphosphoglyceric Acid

FDA classification

FDA Class 1 ·Nadh, Phosphoglycerate Mutase, Atp (U.V.) 2,3-Diphosphoglyceric Acid

PREPOPlus®

Basic UDI-DI

EU MDR · Eu Md Class 1 ·ORTHOPLUS·45 devices

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval

FDA Class 3 ·MEDTRONIC MODEL P1501DR ENRHYTHM IMPLANTABLE PULSE GENERATOR, MEDTRONIC MODEL 9987 APPLICATION SOFTWARE AND MEDTRONIC MO

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·ADVISA DR MRI A2DR01 IMPLANTABLE PULSE GENERATOR

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·MEDTRONIC AT500 DDDRP PACING SYSTEM (MODEL AT501) AND MODEL 9968 SOFTWARE

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·CARELINK MONITOR MODEL 2490G, CARDIOSIGHT READER

Analyzer

FDA registration

Diamond Diagnostics Inc.·29 products·🇭🇺 Hungary

PREMIER COMBO PLUS

FDA UDI

Tensproducts, LLC·00816924020303·TENS/EMS WITH 17 MODES AND AC ADAPTOR, 9 PRESETS

TETRA

FDA UDI

Tensproducts, LLC·00816924020280·TENS/EMS, 4 CHANNEL, 8 MODE, 100mA

COMFYTENS

FDA UDI

Tensproducts, LLC·00816924020266·DIGITAL TENS WITH 5 MODES