9 results
·
19ms
·
Sources: EU EUDAMED, US FDA
Filters
FDA Enforcement
×
Denticator PICK-A-DENT, periodontal aid - intradental pick, REF 621714
FDA Enforcement
Class III
·Ongoing·Young Dental Manufacturing I, LLC·December 28, 2022
Vanguard Complete Knee System, Vanguard CR Lipped Tibial Bearing 10x71/75, Item Number: 183540 Product Usage: For use in total knee arthroplasty
FDA Enforcement
Class II
·Terminated·Zimmer Biomet, Inc.·February 28, 2018
Vanguard Complete Knee System, Vanguard CR Tibial Bearing 12x71/75, Item Number: 183442 Product Usage: For use in total knee arthroplasty
FDA Enforcement
Class II
·Terminated·Zimmer Biomet, Inc.·February 28, 2018
Alinity m SARS-CoV-2 Amp Kit (Non-US Assay) and Alinity m SARS-CoV-2 Application Specification File. in vitro diagnostic
FDA Enforcement
Class I
·Terminated·Abbott Molecular, Inc.·October 20, 2021
HURRICANE RX DILATION BALLOON 4MM 2CM-for endoscopic dilatation of strictures of the biliary tree and the Sphincter of Oddi. UPN: M00545890
FDA Enforcement
Class II
·Ongoing·Boston Scientific Corporation·December 8, 2021
Dimension CTNI-In vitro diagnostic test intended to quantitively measure cardiac troponin-I levels in human serum and heparinized plasma to aid in the diagnosis of myocardial infarction. Siemens Material Number (SMN)/REF (Catalog Number): 10444905/RF421C
FDA Enforcement
Class II
·Terminated·Siemens Healthcare Diagnostics, Inc.·July 13, 2022
Epix latis GRASPER, 5 mm x 35 cm, REF C4130, Qty: 10, Sterile R, CE, Rx ONLY, UDI: (01)00607915110147
FDA Enforcement
Class II
·Terminated·Applied Medical Resources Corp·June 3, 2020
Alinity m SARS-CoV-2 Amp Kit (Emergency Use Authorization, US Assay) and Alinity m SARS-CoV-2 Application Specification File. in vitro diagnostic
FDA Enforcement
Class I
·Terminated·Abbott Molecular, Inc.·October 20, 2021
Access Immunoassay Systems (1) Access 2 Immunoassay Analyzer (81600N); (2) Access 2 Immunoassay Analyzer, Refurbished (386220); (3) Access 2 Immunoassay Analyzer, Refurbished (A65531) ; and (4) Access 2 Section, DxC 600i Packaged(A25640).
FDA Enforcement
Class II
·Ongoing·Beckman Coulter, Inc.·March 22, 2023