9 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Single-Use Video Bronchoscopes, Digital Controller
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
iTero Lumina Cart Configuration
FDA UDI
Align Technology, Inc.·00816063021414·iTero Lumina Intraoral scanner Cart Configuration
DISETRONIC PENFINE INSULIN INJECTION PEN NEEDLE
FDA 510(k)
FDA Class 2
·General Hospital
PARAGON HIP SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
HEMOSPHERE FORESIGHT MODULE
FDA Adverse Event
Malfunction
·EDWARDS LIFESCIENCES·Product code MUD·February 26, 2026
ITREL 3
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code LGW·October 28, 2008
PHILIPS MP50 M3001A
FDA Adverse Event
Injury
·PHILIPS GCX CORP.·Product code DQA·August 16, 2007
2CM PERIPHERAL CUTTING BALLOON?
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - GALWAY·Product code LIT·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