10 results
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10ms
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Sources: EU EUDAMED, US FDA
Filters
Status: Terminated
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ThermaSure(TM), a CENORIN(TM) product, SERIES 1000 MEDICAL DEVICE DRYER: (a) Model 1009; (b) Model 1010 Forced air dryer for medical devices
FDA Recall
Terminated
·Cenorin, LLC·Product code JRJ·June 7, 2017
ThermaSure(TM), a CENORIN(TM) product, SERIES 300 MEDICAL DEVICE DRYER: (a) Model 330; (b) Model 340 Forced air dryer for medical devices
FDA Recall
Terminated
·Cenorin, LLC·Product code JRJ·June 7, 2017
ThermaSure(TM), a CENORIN(TM) product, SERIES 130 MEDICAL DEVICE DRYER: (a) Model 135; (b) Model 136 Forced air dryer for medical devices
FDA Recall
Terminated
·Cenorin, LLC·Product code JRJ·June 7, 2017
Edwards VAMP Jr. 6 in (15 cm) REF: VMP306, Blood Management System, Rx Only, Single Use, CE, Sterile EO UDI: (01)57460691944782
FDA Recall
Terminated
·Edwards Lifesciences, LLC·Product code DXO·May 26, 2021
Edwards VAMP Jr. 6 in (15 cm) REF: VMP306, Blood Management System, Rx Only, Single Use, CE, Sterile EO UDI: (01)57460691944782
FDA Enforcement
Class II
·Terminated·Edwards Lifesciences, LLC·July 7, 2021
Novoste, Beta-Cath 3.5F System, New B-Rail 3.5F Delivery Catheter, with Indicator of Source Train (IST), Novoste Corporate, 3890 Steve Reynolds Blvd, Norcross, GA 30093, Tel: +1770-717-0904, Fax: +1770-717-1283, 1-800-NOVOSTE (1-800-668-6783), www.novoste.com.
FDA Recall
Terminated
·Novoste Corporation·Product code JAJ·January 25, 2002
Hill-Rom Bariatric Power Recliner, Product Model # P9096 Hill-Roms 660 lb Powered Bariatric Recliner was created to provide an aesthetically pleasing design that will enhance the overall experience for the bariatric patient. Using spring box construction and an exceptionally smooth mechanism, the patient is able to move into a reclined position with little effort and infinite positions up to 38 degrees. An independent footrest enables patients to be in a fully seated position with their feet up for added comfort.
FDA Recall
Terminated
·Hill-Rom, Inc.·Product code FRJ·January 20, 2016
Kelyniam Custom Skull Implant (CSI), Model no. PEEK-IM1004
FDA Enforcement
Class II
·Terminated·Kelyniam Global, Inc.·May 23, 2018
Beacon Tip Torcon NB Advantage Catheter. Angiographic catheter. For use in angiographic procedures as a conduit for the delivery of contrast media and can help physicians diagnose occlusion or stenosis. The catheters are designed for percutaneous introduction into the vascular system over an appropriately sized wire guide.
FDA Enforcement
Class I
·Terminated·Cook Inc.·August 12, 2015
Beacon Tip Torcon NB Advantage Catheter Catheter, Intravascular, Diagnostic
FDA Enforcement
Class II
·Terminated·Cook Inc.·August 31, 2016