17 results
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40ms
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Sources: EU EUDAMED, US FDA
SEKISUI DIAGNOSTICS, LLC
FDA registration
SEKISUI DIAGNOSTICS, LLC·1 product·🇺🇸 United States
IMMUNOSTICS, INC.
FDA registration
IMMUNOSTICS, INC.·1 product·🇺🇸 United States
Status First H.pylori
FDA registration
PRINCETON BIOMEDITECH CORP.·1 product·🇺🇸 United States
Sekisui Diagnostics, LLC
FDA registration
Sekisui Diagnostics, LLC·1 product·🇺🇸 United States
PolyStat H. pylori
FDA registration
POLYMEDCO, INC. / POLYMEDCO CANCER DIAGNOSTIC PRODUCTS, LLC.·1 product·🇺🇸 United States
BIOSIGN H. PYLORI WB-NEW ONE-STEP ANTI-H. PYLORI ANTIBODY TEST
FDA 510(k)
FDA Class 1
·Microbiology
K980797
FDA registration
Peregrine Surgical, LLC.·1 product·🇺🇸 United States
Helicobacter Pylori
FDA classification
FDA Class 1
·Helicobacter Pylori
Isomedix Operations, Inc.
FDA registration
Isomedix Operations, Inc.·3 products·🇺🇸 United States
Prime Acetabular Cup System
FDA registration
MICROPORT ORTHOPEDICS INC.·3 products·🇺🇸 United States
Acid Phosphatase Liquid Stabilizer
FDA registration
Fisher Diagnostics·1 product·🇺🇸 United States
ISOMEDIX OPERATIONS INC.
FDA registration
ISOMEDIX OPERATIONS INC.·3 products·🇺🇸 United States
Captia EBNA-1 IgM
FDA registration
Trinity Biotech USA·1 product·🇺🇸 United States
Prime Acetabular Cup System
FDA 510(k)
FDA Class 2
·Orthopedic
INTEL HEALTH GUIDE, MODEL: PHS6000
FDA 510(k)
FDA Class 2
·Cardiovascular
Transmitters And Receivers, Physiological Signal, Radiofrequency
FDA classification
FDA Class 2
·Transmitters And Receivers, Physiological Signal, Radiofrequency
Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
FDA classification
FDA Class 2
·Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented