81 results
·
34ms
·
Sources: EU EUDAMED, US FDA
Filters
Status: Open, Classified
×
EVEXIA LUXE DVT PREVENTION DEVICE, Aid in the Prevention of Deep Vein Thrombosis, REF(s): EVE-11/EVE-X11, Rx Only, Not Sterile
FDA Recall
Open, Classified
·Ortho8, Inc.·Product code JOW·July 9, 2021
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 Recall
Open, Classified
·Ortho8, Inc.·Product code JOW·July 9, 2021
Brand Name: NOVA ORTHO-MED INC. Product Name: MONARCH ROLLATOR PURPLE Model/Catalog Number: 4329PL Product Description: ROLLING WALKER MOBILITY AID
FDA Recall
Open, Classified
·Nova Ortho-Med Inc·Product code ITJ·August 26, 2024
Brand Name: NOVA ORTHO-MED INC. Product Name: MONARCH ROLLATOR BLUE Model/Catalog Number: 4329BL Product Description: ROLLING WALKER MOBILITY AID
FDA Recall
Open, Classified
·Nova Ortho-Med Inc·Product code ITJ·August 26, 2024
Brand Name: NOVA ORTHO-MED INC. Product Name: MONARCH ROLLATOR RED Model/Catalog Number: 4329RD Product Description: ROLLING WALKER MOBILITY AID
FDA Recall
Open, Classified
·Nova Ortho-Med Inc·Product code ITJ·August 26, 2024
Star 8 Rolling Walker/Rollator, Items: 4258/ BK(Black)/ BL(Blue)/ DB(Sky Blue)/ PL(Purple)/ RD(Red)
FDA Recall
Open, Classified
·Nova Ortho-Med Inc·Product code ITJ·October 7, 2019
Vertebral Motion Analyzer (VMA), 2.3.250. Product System, image processing, radiological
FDA Recall
Open, Classified
·Ortho Kinematics, Inc·Product code LLZ·May 23, 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 Recall
Open, Classified
·Ortho Kinematics, Inc·Product code LLZ·March 2, 2017
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 Recall
Open, Classified
·Ortho Kinematics, Inc·Product code LLZ·January 11, 2017
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 Recall
Open, Classified
·Ortho Kinematics, Inc·Product code LLZ·August 12, 2016
VITROS Immunodiagnostic Products FSH Reagent Pack- IVD 1931922
FDA Recall
Open, Classified
·Ortho-Clinical Diagnostics, Inc·Product code CGJ·March 25, 2022
VITROS 3600 Immunodiagnostic System Product Code 6802783 and Refurbished Product Code 6802914 Running Software Version 3.8.0
FDA Recall
Open, Classified
·Ortho-Clinical Diagnostics, Inc.·Product code JJE·October 10, 2023
VITROS 3600 Immunodiagnostic System Catalog Nos. 6802783 (regular) and 6802914 (refurbished)
FDA Recall
Open, Classified
·Ortho-Clinical Diagnostics, Inc.·Product code JJE·January 26, 2024
VITROS Immunodiagnostic Products Anti-SARSCoV- 2 Total N Antibody Calibrators programmed onto the Assay Data Disks (ADD) Data Release Versions (DRV): DRVs 6213 through 6218 supporting VITROS Calibrators. Product Code: 6199976
FDA Recall
Open, Classified
·Ortho-Clinical Diagnostics, Inc.·Product code QKO·March 9, 2023
VITROS Chemistry Products Calibrator Kit 11 VANC Reagent Generation (GEN) 50 with affected Assay Data Disk (ADD) for Data Release Versions (DRVs) 6215 through 6223. In vitro diagnostic -VITROS Chemistry Products Calibrator Kit 11 is used to calibrate the VITROS 5,1 FS/4600 Chemistry Systems and the VITROS 5600/XT 7600 Integrated Systems for the quantitative measurement of vancomycin (VANC). Product Code: 6801696
FDA Recall
Open, Classified
·Ortho-Clinical Diagnostics, Inc.·Product code DLJ·April 14, 2023
VITROS Chemistry Products CRP Slides- In vitro diagnostic quantitatively measures C-reactive protein (CRP) concentration in serum and plasma Model/Catalog Number: 1926740
FDA Recall
Open, Classified
·Ortho-Clinical Diagnostics, Inc.·Product code DCK·October 11, 2024
VITROS Chemistry Products CRP Slides. One sales unit contains 5 cartridges, of 18 slides per cartridge, for a total of 90 slides.
FDA Recall
Open, Classified
·Ortho-Clinical Diagnostics, Inc.·Product code DCK·April 14, 2025
Brand Name: VITROS Product Name: VITROS 5600 Integrated System Model/Catalog Number: 6802413 (New), 6802415 (Certified/Refurbished), 6904001 (China) Software Version: version 3.8.0 or higher Product Description: In vitro diagnostic chemistry analyzer. FDA 3 letter product code: JJE Component: No, not a component
FDA Recall
Open, Classified
·Ortho-Clinical Diagnostics, INc.·Product code JJE·December 19, 2024
Brand Name: VITROS; Product Name: VITROS XT 7600 Integrated System; Model/Catalog Number: (1) 6844461, (2) 6272222; Software Version: version 3.2 to version 3.8.3 (all available software versions); Product Description: In vitro diagnostic chemistry analyzer.
FDA Recall
Open, Classified
·Ortho-Clinical Diagnostics, Inc.·Product code JJE·May 9, 2025
VITROS Immunodiagnostic Products - FSH Reagent Pack (10758750000302) 1931922
FDA Recall
Open, Classified
·Ortho Clinical Diagnostics Inc·Product code CGJ·July 12, 2018