107 results
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Sources: EU EUDAMED, US FDA
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FDA Recall
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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
4205 Journey Rolling Walker Product Usage: used to assist people in walking
FDA Recall
Terminated
·Nova Ortho-Med Inc·Product code ITJ·October 1, 2016
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
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 Recall
Terminated
·Ortho Solutions Inc·Product code HSB·April 19, 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 Recall
Terminated
·Ortho Organizers, Inc.·Product code EJF·April 2, 2019
ClassOne Orthodontics Buccal SS Tubes Label ID Reference Number 351-327 (NF DB UR 6 Convertible .018-14T 14DO HK-Each); ClassOne Orthodontics Buccal SS Tubes Label ID Reference Number 351-328, NF DB UL 6 Convertible .018-14T 14DO HK-Each; ClassOne Orthodontics Buccal SS Tubes Label ID Reference Number 351-418, NF DB UL/LR 6&7 Mini Single .022 0T 0O; ClassOne Orthodontics Buccal SS Tubes Label ID Reference Number 351-427, NF DB UR 6 Convertible .022-14T 14DO HK-Each; ClassOne Orthodontics Label ID Reference Number 351-428, NF DB UL 6 Convertible .022-14T 14DO HK-Each; ClassOne Orthodontics Buccal SS Tubes Label ID Reference Number 351-459, NF DB LR 6 Convertible .022-25T 4DO HK-Each; ClassOne Orthodontics Buccal SS Tubes Label ID Reference Number 351-460, NF DB LL 6 Convertible .022-25T 4DO HK-Each.
FDA Recall
Terminated
·Ortho Organizers Inc·Product code DZD·November 1, 2010
FPS 35mm x 3.5 mm non-locking screw
FDA Recall
Terminated
·Ortho Solutions Inc·Product code HWC·July 21, 2016
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
Maestro Orthodontic Bracket REF711-206-10 QTY. 10 Rx Only (01)00190707016517 (10)112233 (422)484
FDA Recall
Terminated
·Ortho Organizers, Inc.·Product code EJF·April 2, 2019
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
7% BSA (Bovine Serum Albumin), Product Code: 8262487 - Product Usage: is used to dilute samples when assay values exceed the reportable (dynamic) range using the VITROS 250/350/5,1 FS/4600 Chemistry Systems and VITROS 5600/XT 7600 Integrated Systems.
FDA Recall
Terminated
·Ortho Clinical Diagnostics Inc·Product code DCF·October 14, 2019