7 results
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9ms
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Sources: EU EUDAMED, US FDA
stryker ORTHOLOC 3Di Fusion Plate MTP Right, REF 58A221RT, bone stabilization and fixation
FDA Enforcement
Class II
·Ongoing·Wright Medical Technology, Inc.·May 3, 2023
stryker ORTHOLOC 3Di Fusion Plate MTP Right, REF 58A220RT, bone stabilization and fixation
FDA Enforcement
Class II
·Ongoing·Wright Medical Technology, Inc.·May 3, 2023
CDI OneView System BPM Probe: Cat. No. CDI753 - CDI OneView BPM Probe, Cat. No. CDI753TK - CDI OneView BPM Probe Trial Kit
FDA Enforcement
Class II
·Ongoing·Terumo Cardiovascular Systems Corporation·July 2, 2025
Orthopantomograph OP300 dental computed tomography x-ray system. The X-ray device produces conventional 2D X-ray images and Xray projection images for the reconstruction of a 3D view. The device is operated and used by qualified healthcare professionals.
FDA Enforcement
Class II
·Ongoing·Palodex Group Oy·August 21, 2024
Brand Name: STA Liatest D-Di Product Name: STA Liatest D-Di Model/Catalog Number: REF 00515 Product Description: The STA¿ - Liatest ¿ D-Di kit is an immuno-turbidimetric assay for the quantitative determination of D-dimer in venous plasma (in 3.2 % sodium citrate) for use on STA-R¿, STA Compact¿ and STA Satellite¿ analyzers by professional laboratory personnel. The STA¿ - Liatest¿ D-Di is intended for use in conjunction with a clinical pretest probability (PTP) assessment model to exclude pulmonary embolism (PE) and deep venous thrombosis (DVT) in outpatients suspected of PE or DVT. Component: No
FDA Enforcement
Class II
·Ongoing·Diagnostica Stago, Inc.·March 25, 2026
Product: STA Liatest D-Di; REF: 00515;
FDA Enforcement
Class II
·Ongoing·Diagnostica Stago, Inc.·October 22, 2025
Terumo CDI OneView Monitoring System Hematocrit / Oxygen Saturation Probe, Catalog Number REF CD1754
FDA Enforcement
Class II
·Ongoing·Terumo Cardiovascular Systems Corporation·April 9, 2025