6,418 results · 41ms · Sources: EU EUDAMED, US FDA

IML 2000 Toxoplasma Quant IgG

FDA registration
Siemens Healthcare Diagnostics Inc.·6 products·🇺🇸 United States

Pepsinogen Ⅱ (CLIA)、PGⅡ Calibrators

Basic UDI-DI
EU IVDR · Eu Ivd Class C ·Shenzhen Mindray Bio-Medical Electronics Co., Ltd.·3 devices

Pepsinogen I (CLIA)、PGⅠCalibrators

Basic UDI-DI
EU IVDR · Eu Ivd Class C ·Shenzhen Mindray Bio-Medical Electronics Co., Ltd.·3 devices

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval
FDA Class 3 ·INGENIO 2 PACEMAKERS. ALTRUA 2 , ESSENTIO, PROPONENT, ACCOLADE. IMPLANTABLE PULSE GENERATOR (PG), ADVANTIO, INGENIO, VI

Biologic Material, Dental

FDA Pre-Market Approval
FDA Class 3 ·Straumann Emdogain

P.J. Brennan & Company Limited

Importer
🇮🇪 Ireland·18 Manufacturers

ENERPEEL GA-70

Basic UDI-DI
EU MDD · Eu Md Class 2a ·GENERAL TOPICS SRL·1 device

Radioimmunoassay, Follicle-Stimulating Hormone

FDA classification
FDA Class 1 ·Radioimmunoassay, Follicle-Stimulating Hormone

Colostrum, Antigen, Antiserum, Control

FDA classification
FDA Class 1 ·Colostrum, Antigen, Antiserum, Control

ENERPEEL GA-70

Basic UDI-DI
EU MDD · Eu Md Class 2b ·GENERAL TOPICS SRL·1 device

ENERPEEL GA-50

Basic UDI-DI
EU MDD · Eu Md Class 2a ·GENERAL TOPICS SRL·1 device

ENERPEEL GA-40

Basic UDI-DI
EU MDD · Eu Md Class 2a ·GENERAL TOPICS SRL·1 device

ENERPEEL GA-30

Basic UDI-DI
EU MDD · Eu Md Class 2a ·GENERAL TOPICS SRL·1 device

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval
FDA Class 3 ·ELITE,ELITE II,MINUET,PREVA,PRODIGY,THERA D,THERA DR IPGS, THERA ID PG,THERA IPG,THERA S IPG,THERA SR IPG,THERA VDD IPG,

EC Certification Service GmbH

Authorized representative
🇦🇹 Austria·8 Manufacturers

ENERPEEL GA-50

Basic UDI-DI
EU MDD · Eu Md Class 2a ·GENERAL TOPICS SRL·1 device

ENERPEEL GA-40

Basic UDI-DI
EU MDD · Eu Md Class 2a ·GENERAL TOPICS SRL·1 device

ENERPEEL GA-30

Basic UDI-DI
EU MDD · Eu Md Class 2a ·GENERAL TOPICS SRL·1 device

Smith & Nephew, Inc. ANTHEM Total Knee System, Genesis Uni Knee System, JOURNEY BCS and II Knee Systems, JOURNEY II CR Knee System, JOURNEY II Uni Knee System, Journey II UK Knee System, JOURNEY II XR Bi-Cruciate Retaining Knee System, JOURNEY PFJ System, JOURNEY Uni Knee System, Legion Hinge Total Knee System, Legion Total Knee System, ZUK Unicompartmental Knee System, ENGAGE Partial Knee System and Porous Patella and Porous Tibial Baseplates

FDA 510(k)
FDA Class 2 ·Orthopedic

P. J. Dahlhausen & Co. GmbH

Authorized representative
🇩🇪 Germany·3 Manufacturers