81 results
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25ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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PuRE PMMA Disc
FDA 510(k)
FDA Class 2
·Dental
THERMAL MASSAGE BED, MODEL 2D-GX
FDA 510(k)
FDA Class 2
·Physical Medicine
NEXGEN PROLONG ALL-POLY PATELLA
FDA 510(k)
FDA Class 2
·Orthopedic
LAMITRODE S-8 LEAD KIT, 60CM LENGTH
FDA Adverse Event
Injury
·ABBOTT MEDICAL·Product code LGW·August 26, 2025
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·October 15, 2014
URETEX SUP URETHRAL SUPPORT SYSTEM
FDA Adverse Event
Injury
·SOFRADIM PRODUCTION·Product code OTN·April 26, 2013
UNICEL DXC 600 SYNCHRON SYSTEM
FDA Adverse Event
Malfunction
·BECKMAN COULTER, INC.·Product code JJE·June 24, 2011
Integra Licox Brain Tissue Oxygen Monitoring 1 x Complete Brain Probe Kit REF IM3.SR Rx Only, Manufacturer GMS- Gesellschaft fur medizinische, Sondentechnik mbH Dofstrasse 2 24247 Melkendorf, Germany Distributed by Integra Neurosciences 311 Enterprise Drive Plainsboro, NJ 08536 USA Used in direct monitoring of the partial pressure of oxygen.
FDA Enforcement
Class II
·Terminated·Integra LifeSciences Corp.·October 30, 2013
FUSION OMNI-TOME
FDA Adverse Event
Malfunction
·COOK ENDOSCOPY·Product code KNS·June 29, 2021
FUSION PRE-LOADED WITH ACROBAT WIRE GUIDE
FDA Adverse Event
Malfunction
·COOK ENDOSCOPY·Product code KNS·May 27, 2021
FUSION OMNI-TOME
FDA Adverse Event
Malfunction
·COOK ENDOSCOPY·Product code KNS·June 1, 2021
FUSION OMNI-TOME PRE-LOADED SPHINCTEROTOME
FDA Adverse Event
Malfunction
·COOK ENDOSCOPY·Product code KNS·April 4, 2022
FUSION OMNI-TOME
FDA Adverse Event
Malfunction
·COOK ENDOSCOPY·Product code KNS·May 28, 2021
FUSION OMNI-TOME
FDA Adverse Event
Injury
·COOK ENDOSCOPY·Product code KNS·July 19, 2021
FUSION® PRE-LOADED WITH ACROBAT WIRE GUIDE
FDA Adverse Event
Malfunction
·WILSON-COOK MEDICAL INC·Product code KNS·December 13, 2023
FUSION OMNI-TOME
FDA Adverse Event
Malfunction
·COOK ENDOSCOPY·Product code KNS·January 11, 2021
FUSION OMNI-TOME
FDA Adverse Event
Malfunction
·COOK ENDOSCOPY·Product code KNS·April 29, 2021
FUSION PRE-LOADED WITH ACROBAT WIRE GUIDE
FDA Adverse Event
Malfunction
·COOK ENDOSCOPY·Product code KNS·May 20, 2021
FUSION OMNI-TOME
FDA Adverse Event
Malfunction
·COOK ENDOSCOPY·Product code KNS·May 3, 2021
FUSION OMNI-TOME
FDA Adverse Event
Malfunction
·COOK ENDOSCOPY·Product code KNS·May 28, 2021