18 results
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32ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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TENS & EMS DEVICE (Model: FM-B2403A)
FDA 510(k)
FDA Class 2
·Neurology
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
KLS Martin Neuro Rongeurs
FDA 510(k)
FDA Class 2
·Neurology
Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Cefiderocol in the dilution range of 0.03-64 ug/ml
FDA 510(k)
FDA Class 2
·Microbiology
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·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
STONE CONE NITINOL UROLOGICAL RETRIEVAL COIL
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC·Product code FGO·October 22, 2008
COLLEAGUE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·August 16, 2011
CONTIGEN BARD COLLAGEN TREATMENT SYRINGE
FDA Adverse Event
Injury
·C.R. BARD, INC. (COVINGTON)·Product code LNM·July 3, 2013
BD CONNECTA¿ STOPCOCK WITH VALVE & EXTENSION TUBING
FDA Adverse Event
Malfunction
·BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.·Product code FMG·January 28, 2019
VICRYL PLUS POLYGLACTIN 910 SUTURE
FDA Adverse Event
Injury
·ETHICON INC.·Product code GAM·October 2, 2024
SFXSYM PDS+ UNI VIO 18IN 1 SA CTX
FDA Adverse Event
Injury
·ETHICON INC.·Product code NEW·October 2, 2024
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