6 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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Allura Xper FD20 OR Table; Catalog numbers: (1) 722023, (2) 722035.
FDA Enforcement
Class I
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·February 26, 2025
O.T.D - Optimum Traction Device - Street Orange. Single use traction splint.
FDA Enforcement
Class II
·Ongoing·Emergency Products & Research·April 3, 2024
Allura Xper FD20 OR Table Product Codes: (1)722023, (2) 722035, (3) 722015; Associated 510(k) numbers: K102005, K130842, K130638, K133292, K141979, K161563, K162859, K033737, K041949;
FDA Enforcement
Class II
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·October 1, 2025
AlluraXper FD20 OR Table System Code: (1) 722023 (2) 722035
FDA Enforcement
Class II
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·February 12, 2025
Brand Name: Sterilmed Reprocessed Imaging Catheter Product Name: ACUSON, CATHETER ACUNAV DIAGNOSTIC ULTRASOUND 8FR FOR USE WITH SIEMENS SYSTEM Model/Catalog Number: ACU10135936 Software Version: N/A Product Description: ACUSON, CATHETER ACUNAV DIAGNOSTIC ULTRASOUND 8FR FOR USE WITH SIEMENS SYSTEM Component: N/A
FDA Enforcement
Class II
·Ongoing·Sterilmed, Inc.·November 26, 2025
Hemoglobin A1c Control, Part no. 220232 for use as quality control material to monitor the precision of laboratory testing procedures for HbA1c quantitation.
FDA Enforcement
Class III
·Terminated·Tosoh Bioscience Inc·December 19, 2018