4,934 results
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41ms
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Sources: EU EUDAMED, US FDA
Analyzer, Diagnostic, Fiber Optic (Colon)
FDA Pre-Market Approval
FDA Class 3
·OPTICAL BIOPSY(TM) SYSTEM
2CM PERIPHERAL CUTTING BALLOON, SMALL PERIPHERAL CUTTING BALLOON WITH MONORAIL AND OVER-THE-WIRE DELIVERY SYSTEMS
FDA 510(k)
FDA Class 2
·Cardiovascular
LAP DISC 120 X 120MM X 2CM #LD111; LAP DISC 120 X 120MM X 7CM #LD112
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
SCANLAN® Minimally Invasive Instrumentation
FDA UDI
SCANLAN INTERNATIONAL INC·00846159021271·SCANLAN® CardioVasive™ /Thoracoscopic Fine Need...
HUMAN (IGG) SUBCLASS (EIA) KIT
FDA 510(k)
FDA Class 1
·Immunology
AMINOGLYCOSIDE CONTROLS
FDA 510(k)
FDA Class 1
·Immunology
HUMAN IGG SUBCLASSES NEPHELOMETRIC BNA KIT
FDA 510(k)
FDA Class 1
·Immunology
ANTISERUM TO HUMAN IG G FC FRAGMENTS
FDA 510(k)
FDA Class 1
·Immunology
HUMAN IGG SUBCLASSES ELISA COMBI KIT
FDA 510(k)
FDA Class 1
·Immunology
HUMAN IGG SUBCLASSES RID COMBI KIT (MODIFICATION)
FDA 510(k)
FDA Class 1
·Immunology
PELICALSS HUMAN IGG SUBCLASS NEPHLOMETRIC ARRAY KIT
FDA 510(k)
FDA Class 1
·Immunology
ANTISERUM TO HUMAN FC
FDA 510(k)
FDA Class 1
·Immunology
Needle Guide Starter Kit
FDA UDI
CIVCO MEDICAL INSTRUMENTS CO., INC.·00841436107037·Reusable non-sterile bracket with sterile needl...
Needle Guide Starter Kit
FDA UDI
CIVCO MEDICAL INSTRUMENTS CO., INC.·00841436107020·Reusable non-sterile bracket with sterile needl...
Straumann BLX Ø3.5 mm Implants
FDA 510(k)
FDA Class 2
·Dental
ELMED
FDA UDI
ELMED INCORPORATED·00842180167315·STAINLESS STEEL WEIGHTED HANDLE, 1.5 LBS, 4 1/1...
Needle Guide Start Kit
FDA UDI
CIVCO MEDICAL INSTRUMENTS CO., INC.·00841436181211·Reusable non-sterile bracket with sterile (1cm,...
SCANLAN® Jacobson Needle Holder
FDA UDI
SCANLAN INTERNATIONAL INC·00846159030242·SCANLAN® CardioVasive™ Jacobson Needle Holder (...
Needle Guide Starter Kit
FDA UDI
CIVCO MEDICAL INSTRUMENTS CO., INC.·00841436110129·Reusable non-sterile bracket with sterile (1cm,...
Needle Guide Starter Kit
FDA UDI
CIVCO MEDICAL INSTRUMENTS CO., INC.·00841436110112·Reusable non-sterile bracket with sterile (1cm,...