7 results
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19ms
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Sources: EU EUDAMED, US FDA
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FDA Enforcement
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EL-Anti-SARS-CoV-2 IgM Kit, Catalog #104-129, IVD. Submitted as EUA202129
FDA Enforcement
Class II
·Terminated·Thera Test Laboratories, Inc.·September 8, 2021
EL-Anti-SARS-CoV-2 IgG Kit, Catalog #104-130. Submitted as EUA202128
FDA Enforcement
Class II
·Terminated·Thera Test Laboratories, Inc.·September 8, 2021
E25Bio COVID-19 Direct Antigen Rapid Test ; E25Bio COVID-19 DART Kit
FDA Enforcement
Class I
·Terminated·E25Bio, Inc.·February 16, 2022
Alinity m Resp-4-Plex AMP Kit (Non-US Assay) and Alinity m Resp-4-Plex Application Specification File. in vitro diagnostic
FDA Enforcement
Class I
·Terminated·Abbott Molecular, Inc.·October 20, 2021
Sterile Custom Packs to be used in surgical procedures.
FDA Enforcement
Class II
·Terminated·American Contract Systems·June 10, 2020
Orthofix Power Drill Torque Limiter, Sterile, Rx Only, Single Use; Sold individually and in the Galaxy UNYCO Diaphyseal Tibia Sterile Kit, Galaxy UNYCO Mini Kit Instruments Sterile, Galaxy UNYCO Diaphyseal Femur Box, Galaxy UNYCO Knee Bridging Box, Galaxy UNYCO Ankle Bridging Box - Unilateral Frame, Galaxy UNYCO Ankle Bridging Box - Delta Frame, and Galaxy UNYCO Diaphyseal Tibia Box. Intended to be used for temporary bone stabilization in trauma and orthopedic procedures of the lower limb prior to definitive treatment.
FDA Enforcement
Class II
·Terminated·Orthofix Srl·January 3, 2018
TrueBeam Radiotherapy Delivery System version 2.0 and 2.5 EDGE Radiotherapy Delivery System version 2.0 and 2.5 Product Usage: The TrueBeam delivery systems are intended to provide radiotherapy and stereotactic radiosurgery for lesions, tumors, and conditions anywhere in the body where radiation treatment is indicated.
FDA Enforcement
Class II
·Terminated·Varian Medical Systems·October 10, 2018