77 results
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115ms
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Sources: EU EUDAMED, US FDA
PRODUCTION SYSTEMS, INC.
FDA registration
PRODUCTION SYSTEMS, INC.·1 product·🇺🇸 United States
illumipro-10
FDA UDI
MERIDIAN BIOSCIENCE, INC.·00840733101243·The illumipro-10 is an automated isothermal amp...
Prosthesis, Spinous Process Spacer/Plate
FDA Pre-Market Approval
FDA Class 3
·Superion Indirect Decompression System
Monitor, Skin Resistance/Skin Temperature, For Insulin Reactions
FDA Pre-Market Approval
FDA Class 3
·SLEEP SENTRY
Tissue Adhesive For Use In Embolization Of Brain Arteriovenous Malformations
FDA Pre-Market Approval
FDA Class 3
·Trufill n-Butyl Cyanoacrylate (n-BCA) Liquid Embolic System
System, Test, Her-2/Neu, Ihc
FDA Pre-Market Approval
FDA Class 3
·PATHWAY HER-2/NEU (4B5) RABBIT MONOCLONAL PRIMARY ANTIBODY
Implant, Intragastric For Morbid Obesity
FDA Pre-Market Approval
FDA Class 3
·RESHAPE INTEGRATED DUAL BALLOON SYSTEM,RESHAPE BALLOON ASSEMBLY,RESHAPE REMOVAL CATHETER,RESHAPE VALVE SEALANT
Guidewire 0.6
FDA UDI
Fiagon GmbH·EFIAE0129131·The products GuideWire 0.6 is a variant of a na...
PointerShell LS
FDA UDI
Fiagon GmbH·EFIAE0129061·The product PointerShell LS
is a product varia...
Guidewire 0.6 Single Use
FDA UDI
Fiagon GmbH·EFIAE0139131·The product GuideWire 0.6 Singel Use is a varia...
Chromogenic In Situ Hybridization, Nucleic Acid Amplification, Her2/Neu Gene, Breast Cancer
FDA Pre-Market Approval
FDA Class 3
·INFORM HER2 Dual ISH DNA Probe Cocktail assays
MODEL NUMBER: RMS1-2604, RMS1-2614, RMS1-2404, RMS1-2414, RMS2-2604, RMS2-2614, RMS2-2404, RMS2-2414, RMS3-2604, RMS3-26
FDA 510(k)
FDA Class 2
·General Hospital
Integrated Catch-up Freedom Syringe Driver Infusion System
FDA 510(k)
FDA Class 2
·General Hospital
HIgH-Flo Super26 Subcutaneous Needle Sets
FDA 510(k)
FDA Class 2
·General Hospital
System, Test, Her-2/Neu, Ihc
FDA Pre-Market Approval
FDA Class 3
·PATHWAY Anti-HER-2/neu (4B5) Rabbit Monoclonal Primary Antibody
HOROS MD
FDA UDI
ICAT SOLUTIONS LTD·05070002336808·The Horos MD™ is an interactive image display a...
Ossano Scandinavia Oy Ab
Importer
🇫🇮 Finland·3 Manufacturers
MedNet EC-REP IIb GmbH
Authorized representative
🇩🇪 Germany·32 Manufacturers·165 Devices
MPS Medical Product Service GmbH
Authorized representative
🇩🇪 Germany·35 Manufacturers·1959 Devices
OMC NI MEDICAL LIMITED
Authorized representative
13 Manufacturers·18 Devices