10,000 results · 56ms · Sources: EU EUDAMED, US FDA

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Tortoise Turning and Positioning System

FDA registration
Molnlycke Manufacturing US, LLC·1 product·🇺🇸 United States

BinaxNOW Streptococcus pneumoniae Test

FDA registration
Abbott Diagnostics Scarborough, Inc.·1 product·🇺🇸 United States

BinaxNow Strep A Test

FDA registration
ABBOTT DIAGNOSTICS SCARBOROUGH, INC.·1 product·🇺🇸 United States

Legionella Urinary Antigen Enzyme Immunoassay Kit

FDA registration
ABBOTT DIAGNOSTICS SCARBOROUGH, INC.·1 product·🇺🇸 United States

Validate CM2 product code 402ab

FDA registration
LGC Clinical Diagnostics, Inc.·1 product·🇺🇸 United States

Multiple

FDA registration
ACME-MONACO CORP.·1 product·🇺🇸 United States

Lipoprotein 1 Calibration Verification Test Set

FDA registration
LGC Clinical Diagnostics, Inc.·1 product·🇺🇸 United States

VALIDATE GC3 Calibration Verification / Linearity Test Kit

FDA registration
LGC Clinical Diagnostics, Inc.·1 product·🇺🇸 United States

Implant, Cochlear

FDA Pre-Market Approval
FDA Class 3 ·MED-EL COMBI 40+ COCHLEAR IMPLANT SYSTEM PULSARCI100 COCHLEAR IMPLANT

Omnilux Clear

Device
EU MDR · Eu Md Class 2a ·I-SMART DEVELOPMENTS LIMITED·On the market·5 countries

Group B Streptococcus Antigen Detection Kit (Immunochromatography)

FDA registration
JIANGSU MACRO & MICRO-TEST MED-TECH CO., LTD.·1 product·🇨🇳 China

Easy Amp Real-time Fluorescence Isothermal Detection System, EudemonTM AIO800

FDA registration
JIANGSU MACRO & MICRO-TEST MED-TECH CO., LTD.·1 product·🇨🇳 China

Macro & Micro-Test Fluorescence Reader

FDA registration
JIANGSU MACRO & MICRO-TEST MED-TECH CO., LTD.·1 product·🇨🇳 China

Detection Kit for Group A rotavirus and Adenovirus antigens (Colloidal gold)

FDA registration
JIANGSU MACRO & MICRO-TEST MED-TECH CO., LTD.·1 product·🇨🇳 China

Macro & Micro-Test HCG Preganancy Test Midstream

FDA registration
JIANGSU MACRO & MICRO-TEST MED-TECH CO., LTD.·1 product·🇨🇳 China

Nucleic Acid Detection Kit based on Enzymatic Probe Isothermal Amplification (EPIA) for Group B Streptococcus

FDA registration
JIANGSU MACRO & MICRO-TEST MED-TECH CO., LTD.·1 product·🇨🇳 China

Insulin-like Growth Factor Binding Protein-1 (IGFBP-1) Detection Kit (Immunochromatography)

FDA registration
JIANGSU MACRO & MICRO-TEST MED-TECH CO., LTD.·1 product·🇨🇳 China

Macro & Micro-Test LH Test

FDA registration
JIANGSU MACRO & MICRO-TEST MED-TECH CO., LTD.·1 product·🇨🇳 China

Clostridium Difficile Glutamate Dehydrogenase(GDH) and Toxin A/B Detection Kit (Immunochromatography)

FDA registration
JIANGSU MACRO & MICRO-TEST MED-TECH CO., LTD.·1 product·🇨🇳 China

Macro & Micro-Test Sample Collecting, Mailing & Shipping Kit

FDA registration
JIANGSU MACRO & MICRO-TEST MED-TECH CO., LTD.·1 product·🇨🇳 China