7 results
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13ms
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Sources: EU EUDAMED, US FDA
Filters
Status: Ongoing
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STANDARD Q COVID-19 Ag Home Test STANDARD Q COVID-19 Ag Home Test is a rapid chromatographic immunoassay for the qualitative detection of SARS-CoV-2 nucleocapsid antigen present in human nasal sample.
FDA Enforcement
Class I
·Ongoing·SD Biosensor, Inc.·March 23, 2022
On-X Mitral Heart Valve with Conform-X Sewing Ring, Model: ONXMC-25/33
FDA Enforcement
Class II
·Ongoing·On-X Life Technologies, Inc.·May 20, 2026
VACUETTE SAFELINK, REF: 450210
FDA Enforcement
Class II
·Ongoing·Greiner Bio-One GmbH·January 15, 2025
VACUETTE TUBE 4 ml FX Sodium Fluoride/Potassium Oxalate, Item #454297, 13x75 grey cap-black ring, non-ridged.
FDA Enforcement
Class II
·Ongoing·Greiner Bio-One North America, Inc.·January 24, 2024
VACUETTE¿ TUBE 8 ml CAT Serum Separator Clot Activator 16x100 red cap-yellow ring, non-ridged
FDA Enforcement
Class II
·Ongoing·Greiner Bio-One North America, Inc.·July 24, 2024
Greiner BIO-ONE VACUETTE 2 ml 9NC Coagulation sodium citrate 3.2%, REF: 454322
FDA Enforcement
Class II
·Ongoing·Greiner Bio-One North America, Inc.·November 5, 2025
Brand Name: Vacuette Product Name: 8 ml CAT Serum Separator Clot Activator Model/Catalog Number: 455071P Product Description: Greiner VACUETTE Blood Collection Tube with Clot Activator and Gel Separator and Standard Stopper (16 x 100 mm, 8ml)
FDA Enforcement
Class II
·Ongoing·Greiner Bio-One North America, Inc.·November 26, 2025