18 results
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25ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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HealthOST
FDA 510(k)
FDA Class 2
·Radiology
AVOSET INFUSION PUMP ROW
FDA Adverse Event
Malfunction
·EITAN MEDICAL LTD.·Product code FRN·March 25, 2025
AVOSET INFUSION PUMP ROW
FDA Adverse Event
Malfunction
·EITAN MEDICAL LTD.·Product code FRN·March 25, 2025
JOSTRA DUAL STAGE VENOUS RETURN CANNULAE
FDA 510(k)
FDA Class 2
·Cardiovascular
KOSTEC MEDICAL GRADE LDC MONITORS
FDA 510(k)
FDA Class 2
·Radiology
SYRINGE 10ML LL S/C 200
FDA Adverse Event
Malfunction
·BECTON DICKINSON MEDICAL SYSTEMS·Product code FMF·June 9, 2021
AVOSET INFUSION PUMP ROW
FDA Adverse Event
Malfunction
·EITAN MEDICAL LTD.·Product code FRN·March 25, 2025
BD SYRINGE LUER-LOK TIP
FDA Adverse Event
Malfunction
·BECTON DICKINSON MEDICAL SYSTEMS·Product code FMF·April 1, 2021
AVOSET INFUSION PUMP ROW
FDA Adverse Event
Malfunction
·EITAN MEDICAL LTD.·Product code FRN·June 22, 2025
AVOSET INFUSION PUMP ROW
FDA Adverse Event
Malfunction
·EITAN MEDICAL LTD.·Product code FRN·December 23, 2025
AVOSET INFUSION PUMP ROW
FDA Adverse Event
Malfunction
·EITAN MEDICAL LTD.·Product code FRN·January 5, 2026
AVOSET INFUSION PUMP ROW
FDA Adverse Event
Malfunction
·EITAN MEDICAL LTD.·Product code FRN·January 5, 2026
AVOSET INFUSION PUMP ROW
FDA Adverse Event
Malfunction
·EITAN MEDICAL LTD.·Product code FRN·April 29, 2026
MBT CEM KEEL TIB TRAY SZ3
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS, INC.·Product code NJL·October 27, 2008
ASR ACETABULAR CUPS 58
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL, LTD.·Product code KWA·August 12, 2011
ENSPIRE
FDA Adverse Event
Injury
·SPINE VIEW INC.·Product code HRX·July 9, 2013
Subcutaneous Implantable Cardioverter Defibrillator (S-ICD) System, labeled as EMBLEM MRI S-ICD Pulse Generator
FDA Enforcement
Class II
·Ongoing·Boston Scientific Corporation·September 25, 2019
BV Pulsera with Software Release 2.3-A mobile, diagnostic X-ray image acquisition and viewing system. Model Number: 718095
FDA Enforcement
Class II
·Ongoing·Philips North America Llc·December 15, 2021