16 results
·
22ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
G7, Dental Operative Unit and Accessories
FDA 510(k)
FDA Class 1
·Dental
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
ENDOANCHOR AND OPENANCHOR
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
DISPOSABLE POWDER FREE VINYL SYNTHETIC EXAM GLOVES, WITH ALOE VERA, GREEN COLOR
FDA 510(k)
FDA Class 1
·General Hospital
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
ANALYTICAL P MODULE
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code JJE·October 22, 2008
COLLEAGUE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·August 16, 2011
VITALITY 2
FDA Adverse Event
Malfunction
·GUIDANT CRM CLONMEL IRELAND·Product code LWS·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
Philips AneurysmFlow. Model Number: 001015. AneurysmFlow is a software medical device (Interventional Tool) intended to be used in combination with a Philips interventional X-ray system and 3DRA data.
FDA Enforcement
Class II
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·April 22, 2026