106 results
·
27ms
·
Sources: EU EUDAMED, US FDA
Filters
FDA Enforcement
×
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
4205 Journey Rolling Walker Product Usage: used to assist people in walking
FDA Enforcement
Class II
·Terminated·Nova Ortho-Med Inc·November 2, 2016
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
FPS 35mm x 3.5 mm non-locking screw
FDA Enforcement
Class II
·Terminated·Ortho Solutions Inc·September 28, 2016
Ortho OS Solutions UltOS 3.5mm locking screw 12mm to 50mm Ortho Solutions LTD, Unit 5 West Station Business Park, Spital Road, Maldon, Essex CM96FF Rx Only a) Sterile b) Non-Sterile Orthopaedic Bone Screw
FDA Enforcement
Class II
·Terminated·Ortho Solutions Inc·October 14, 2015
Oxford/Oxbridge AFN End Cap 10 mm x 5 mm tp 12 mm x10 mm The end caps are a circular disk with a small threaded shaft to be screwed to the distal end of the Nail.
FDA Enforcement
Class II
·Terminated·Ortho Solutions Inc·August 9, 2017
Maestro Orthodontic Bracket REF711-298Q QTY. 20 Rx Only (01)00190707017064 (10)889437 (422)484 Maestro Orthodontic Bracket REF711-299MCQ QTY. 20 Rx Only (01)00190707017071(10)889437 (422)484
FDA Enforcement
Class II
·Terminated·Ortho Organizers, Inc.·July 8, 2020
Maestro Orthodontic Bracket REF711-206-10 QTY. 10 Rx Only (01)00190707016517 (10)112233 (422)484
FDA Enforcement
Class II
·Terminated·Ortho Organizers, Inc.·July 8, 2020
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