3,148 results · 44ms · Sources: EU EUDAMED, US FDA

FLYWAY

FDA 510(k)
FDA Class 1 ·Ophthalmic

Human BCR-ABL Fusion Gene Mutation Detection Kit (Fluorescence PCR)

Basic UDI-DI
EU IVDD · Eu Ivd General ·Jiangsu Macro & Micro-Test Med-Tech Co., Ltd.·1 device

ZENA MAX BCR/ABL Major Real Time PCR Quantitative Kit

Basic UDI-DI
EU IVDD · Eu Ivd General ·Advanced Molecular Diagnostics Ltd·1 device

Fluid, Intraocular

FDA Pre-Market Approval
FDA Class 3 ·PERFLURON

Sentosa SA BCR-ABL minor Quantitative RT-PCR Test v2.0 (4x8)

Basic UDI-DI
EU IVDD · Eu Ivd General ·Vela Operations Singapore Pte. Ltd.·1 device

Sentosa SA BCR-ABL Major Quantitative RT-PCR Test v2.0 (4x8)

Basic UDI-DI
EU IVDD · Eu Ivd General ·Vela Operations Singapore Pte. Ltd.·1 device

Leukemia BCR-ABL Fusion Gene Typing Real Time RT-PCR Kit

Basic UDI-DI
EU IVDD · Eu Ivd General ·SHANGHAI ZJ BIO-TECH CO., LTD·1 device

Human BCR-ABL Gene T315I Mutation Detection Kit (Multiplex Fluorescence Polymerase Chain Reaction)

Basic UDI-DI
EU IVDD · Eu Ivd General ·XIAMEN SPACEGEN CO.,LTD.·1 device

IMMCO DIAGNOSTICS

FDA UDI
IMMCO DIAGNOSTICS, INC.·00845714004179·Mounting Medium

IMMCO DIAGNOSTICS

FDA UDI
IMMCO DIAGNOSTICS, INC.·00845714004162·Mounting Medium

Bite Block

Basic UDI-DI
EU MDR · Eu Md Class 1 ·G-FLEX FLEXIBLE INSTRUMENTS EUROPE·2 devices

Multiband Ligator

Basic UDI-DI
EU MDR · Eu Md Class 1 ·G-FLEX FLEXIBLE INSTRUMENTS EUROPE·1 device

Multiple Autoantibodies, Indirect Immunofluorescent, Antigen, Control

FDA classification
FDA Class 2 ·Multiple Autoantibodies, Indirect Immunofluorescent, Antigen, Control

Absorbent, Carbon-Dioxide

FDA classification
FDA Class 1 ·Absorbent, Carbon-Dioxide

Trocar, Tracheal, Laryngeal, Sinus, Reprocessed

FDA classification
FDA Class 1 ·Trocar, Tracheal, Laryngeal, Sinus, Reprocessed

Infant Supine Sleep System

FDA classification
FDA Class 2 ·Infant Supine Sleep System

KL Global Procurement e.K.

Importer
🇩🇪 Germany

Control Material, Blood Circulating Epithelial Cancer Cell

FDA classification
FDA Class 2 ·Control Material, Blood Circulating Epithelial Cancer Cell

Percutaneous Cardiac Ablation Catheter For Treatment Of Atrial Fibrillation With Irreversible Electroporation

FDA Pre-Market Approval
FDA Class 3 ·FARAPULSE™ Pulsed Field Ablation System (FARAWAVE™ Pulsed Field Ablation Catheter, FARAWAVE™ NAV Pulsed Field Ablation C

Medical Device Management Ltd

Authorized representative
🇮🇪 Ireland·27 Manufacturers·1124 Devices