30 results
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26ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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ADI TiDAL Osteotomy Wedge
FDA 510(k)
FDA Class 2
·Orthopedic
NEONATE ARRAY COILS
FDA 510(k)
FDA Class 2
·Radiology
PTA-DUO PTA BALLOON CATHETER
FDA 510(k)
FDA Class 2
·Cardiovascular
FUJIFILM DUODENOSCOPE MODEL ED-580T
FDA Adverse Event
Injury
·FUJIFILM CORPORATION·Product code FDT·September 5, 2023
FUJIFILM ENDOSCOPE
FDA Adverse Event
Malfunction
·FUJIFILM CORPORATION·Product code FDS·March 18, 2022
FUJIFILM DUODENOSCOPE ED-580T
FDA Adverse Event
Injury
·FUJIFILM CORPORATION·Product code FDT·March 5, 2025
ASR UNI FEMORAL IMPL SIZE 41
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL·Product code KWA·June 26, 2013
HEARTSTREAM FR2
FDA Adverse Event
Malfunction
·PHILIPS MEDICAL SYSTEMS (HTST)·Product code MKJ·July 25, 2011
MESH
FDA Adverse Event
Injury
·DAVOL INC., SUB. C.R. BARD, INC.·Product code FTL·September 24, 2008
Medtronic MiniMed(TM) Sure-T(TM) (MMT-862, 862T, 864, 864T, 866, 866T, 874, 874T, 876, 876T, 884, 886, 886T)
FDA Enforcement
Class II
·Ongoing·Medtronic Inc.·November 29, 2017
ACUSNARE POLYPECTOMY SNARE
FDA Adverse Event
Malfunction
·COOK ENDOSCOPY·Product code FDI·December 2, 2020
ACUSNARE POLYPECTOMY SNARE
FDA Adverse Event
Malfunction
·COOK ENDOSCOPY·Product code FDI·October 23, 2020
ACUSNARE POLYPECTOMY SNARE
FDA Adverse Event
Malfunction
·COOK ENDOSCOPY·Product code FDI·December 2, 2020
ACUSNARE POLYPECTOMY SNARE
FDA Adverse Event
Malfunction
·COOK ENDOSCOPY·Product code FDI·November 30, 2020
ACUSNARE POLYPECTOMY SNARE
FDA Adverse Event
Malfunction
·COOK ENDOSCOPY·Product code FDI·December 11, 2020
ACUSNARE POLYPECTOMY SNARE
FDA Adverse Event
Malfunction
·COOK ENDOSCOPY·Product code KNS·August 31, 2021
ACUSNARE POLYPECTOMY SNARE
FDA Adverse Event
Malfunction
·WILSON-COOK MEDICAL INC·Product code FDI·January 9, 2024
ACUSNARE POLYPECTOMY SNARE
FDA Adverse Event
Malfunction
·WILSON-COOK MEDICAL INC·Product code FDI·January 9, 2024
ACUSNARE POLYPECTOMY SNARE
FDA Adverse Event
Malfunction
·WILSON-COOK MEDICAL INC·Product code FDI·December 5, 2022
ACUSNARE POLYPECTOMY SNARE
FDA Adverse Event
Malfunction
·COOK ENDOSCOPY·Product code FDI·April 20, 2021