81 results
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25ms
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Sources: EU EUDAMED, US FDA
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Status: Ongoing
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CIRCUL8 LUXE DVT PREVENTION DEVICE, Aid in the Prevention of Deep Vein Thrombosis, REF: 08-0020, Rx Prescription Only, Not Sterile IP22, Latex Free,
FDA Enforcement
Class II
·Ongoing·Ortho8, Inc.·August 25, 2021
EVEXIA LUXE DVT PREVENTION DEVICE, Aid in the Prevention of Deep Vein Thrombosis, REF(s): EVE-11/EVE-X11, Rx Only, Not Sterile
FDA Enforcement
Class II
·Ongoing·Ortho8, Inc.·August 25, 2021
Brand Name: NOVA ORTHO-MED INC. Product Name: MONARCH ROLLATOR RED Model/Catalog Number: 4329RD Product Description: ROLLING WALKER MOBILITY AID
FDA Enforcement
Class II
·Ongoing·Nova Ortho-Med Inc·October 23, 2024
Brand Name: NOVA ORTHO-MED INC. Product Name: MONARCH ROLLATOR BLUE Model/Catalog Number: 4329BL Product Description: ROLLING WALKER MOBILITY AID
FDA Enforcement
Class II
·Ongoing·Nova Ortho-Med Inc·October 23, 2024
Brand Name: NOVA ORTHO-MED INC. Product Name: MONARCH ROLLATOR PURPLE Model/Catalog Number: 4329PL Product Description: ROLLING WALKER MOBILITY AID
FDA Enforcement
Class II
·Ongoing·Nova Ortho-Med Inc·October 23, 2024
Star 8 Rolling Walker/Rollator, Items: 4258/ BK(Black)/ BL(Blue)/ DB(Sky Blue)/ PL(Purple)/ RD(Red)
FDA Enforcement
Class II
·Ongoing·Nova Ortho-Med Inc·December 30, 2020
Vertebral Motion Analyzer (VMA) Version 2.3.252. VMA software is a quantitative imaging software application intended to be used to process digital image files.
FDA Enforcement
Class II
·Ongoing·Ortho Kinematics, Inc·August 29, 2018
Vertebral Motion Analyzer (VMA), 2.3.250. Product System, image processing, radiological
FDA Enforcement
Class II
·Ongoing·Ortho Kinematics, Inc·August 29, 2018
Vertebral Motion Analyzer (VMA), 2.3.239 - 2.3.254. Product Usage: VMA software is a quantitative imaging software application intended to be used to process digital image files.
FDA Enforcement
Class II
·Ongoing·Ortho Kinematics, Inc·August 29, 2018
Vertebral Motion Analyzer (VMA), VMA DataLink Software.2.3.231, 2.3.232. Product Usage: VMA software is a quantitative imaging software application intended to be used to process digital image files.
FDA Enforcement
Class II
·Ongoing·Ortho Kinematics, Inc·August 29, 2018
VITROS Chemistry Products LAC Slides. Catalog Number: 8150112. 1 Sales Unit = contains 5 cartridges of 18 slides, for a total of 90 tests.
FDA Enforcement
Class II
·Ongoing·Ortho-Clinical Diagnostics, Inc.·September 24, 2025
Chemistry Products LAC Slides. Catalog Number: 8433880. 1 Sales Unit = contains 5 cartridges of 60 slides, for a total of 300 tests.
FDA Enforcement
Class II
·Ongoing·Ortho-Clinical Diagnostics, Inc.·September 24, 2025
VITROS Chemistry Products Ca Slides; Catalog Number: 145 0261;
FDA Enforcement
Class II
·Ongoing·Ortho-Clinical Diagnostics, Inc.·August 27, 2025
Brand Name: VITROS Chemistry Products Product Name: VITROS Chemistry Products Performance Verifier II Model/Catalog Number: 8231474 Software Version: N/A Product Description: VITROS Chemistry Products Performance Verifier is an assayed control used to monitor performance on VITROS 250/350/5,1 FS/4600/XT 3400 Chemistry Systems and the VITROS 5600/XT 7600 Integrated Systems. VITROS Performance Verifier is prepared from processed human serum to which enzymes, electrolytes, stabilizers,mpreservatives and other organic analytes have been added. Component: No, not a component
FDA Enforcement
Class II
·Ongoing·Ortho-Clinical Diagnostics, Inc.·July 23, 2025
Brand Name: VITROS Chemistry Products Product Name: VITROS Chemistry Products Performance Verifier I Model/Catalog Number: 806 7324 Software Version: Not Applicable Product Description: VITROS Chemistry Products Performance Verifier is an assayed control used to monitor performance on VITROS 250/350/5,1 FS/4600/XT 3400 Chemistry Systems and the VITROS 5600/XT 7600 Integrated Systems. VITROS Performance Verifier is prepared from processed human serum to which enzymes, electrolytes, stabilizers,mpreservatives and other organic analytes have been added. Component: No, not a component
FDA Enforcement
Class II
·Ongoing·Ortho-Clinical Diagnostics, Inc.·July 23, 2025
VITROS Chemistry Products CHE Slides; Catalog Numbers: (1) 191 4605 (300 slides), (2) 800 4707 (90 slides);
FDA Enforcement
Class II
·Ongoing·Ortho-Clinical Diagnostics, Inc.·July 23, 2025
Brand Name: Solana¿ Bordetella Complete Assay Product Name: Solana Bordetella kit Model/Catalog Number: M308 Software Version: not applicable Product Description: One sales unit (kit) contains materials for 48 tests. One kit contains 48 tubes of 1.45 mL Process Buffer and 48 Reaction Tubes. Component: No, not a component
FDA Enforcement
Class II
·Ongoing·Ortho-Clinical Diagnostics, Inc.·June 18, 2025
Brand Name: VITROS Product Name: VITROS 5600 Integrated System Model/Catalog Number: (1) 6802413, (2) 6802915
FDA Enforcement
Class II
·Ongoing·Ortho-Clinical Diagnostics, Inc.·July 9, 2025
VITROS Chemistry Products CHE Slides (Japan); Catalog Numbers: (1) 684 4074 (90 slides), (2) 684 4138 (300 slides);
FDA Enforcement
Class II
·Ongoing·Ortho-Clinical Diagnostics, Inc.·July 23, 2025
VITROS Chemistry Products OP Reagent Gen 15. Model Number: 680 1997. The VITROS OP Reagent is a dual-chambered package containing ready-to-use liquid reagents that are used to detect opiates in urine. One sales unit contains 6 Microtip packs of reagent. Each pack has 50 OP tests.
FDA Enforcement
Class II
·Ongoing·Ortho-Clinical Diagnostics, Inc.·July 9, 2025